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Jeanine's liver hurts. "Janine": the effectiveness and side effects of hormonal contraceptive

Dosage form

Sugar-coated tablets

Compound

One tablet contains

active substances: ethinylestradiol 0.03 mg,

dienogest 2.0 mg,

Excipients: lactose monohydrate, corn starch, maltodextrin, magnesium stearate,

cthe rest of the shell: sucrose, liquid glucose, calcium carbonate, povidone K 25, macrogol 35000, titanium dioxide (E 171), carnauba wax.

Description

Smooth, white, sugar-coated tablets, round shape

Pharmacotherapeutic group

Sex hormones and modulators of the reproductive system.

Hormonal contraceptives for systemic use.

Progestogens and estrogens (fixed combination). dienogest and estrogen.

ATX code G03AA16

Pharmacological properties

The state of equilibrium concentration is reached during the second half of the treatment cycle, when the serum level of the drug increases by about 2 times compared with the level when taking a single dose of the drug.

Pharmacodynamics

Janine â - an oral combined contraceptive preparation containing ethinyl estradiol and the progestogen dienogest.

The contraceptive effect of Jeanine® is based on the interaction of various factors, the most important of which are the inhibition of ovulation and changes in the secretion of cervical mucus.

Dienogest is a nortestosterone derivative with an in vitro affinity for progesterone receptors 10-30 times less than other synthetic progestogens.

In vivo animal data have demonstrated potent progestogenic and antiandrogenic activity.

Dienogest does not have significant androgenic, mineralocorticoid or glucocorticoid activity in vivo.

It has been established that dienogest contributes to the inhibition of ovulation at a dose of 1 mg per day.

When using high-dose oral contraceptives (0.05 mg ethinyl estradiol), the risk of developing endometrial and ovarian cancer is reduced. The extent to which these data relate to low-dose contraceptives requires further study.

Indications for use

Oral contraception (see section "Special Instructions")

Dosage and administration

The tablets should be taken orally in the order indicated on the package, every day at about the same time, with a little water. Take one tablet per day continuously for 21 days. The next pack is started after a 7-day tablet break, during which withdrawal bleeding usually occurs. Bleeding usually starts 2-3 days after taking the last pill and may not end before starting a new pack.

How to start taking Jeanine ®

In the absence of taking any hormonal contraceptives in the previous month

Janine® is started on the first day of the menstrual cycle (i.e. the first day of menstrual bleeding).

When switching from other combined oral contraceptives (COCs)

It is preferable to start taking Janine the next day after taking the last hormone-containing tablet from the previous package of combined oral contraceptive, but in no case later than the next day after the usual 7-day break (for preparations containing 21 tablets) or after taking the last hormone-free tablet for preparations containing 28 tablets per package).

· When switching from vaginal ring, transdermal patch

It is preferable to start taking Janine® on the day of removal of the last ring or patch, but in no case later than the day when the next ring or patch should have been applied.

· When switching from contraceptives containing only gestagens ("mini-pill", injectable forms, implant) or from a progestogen-releasing intrauterine system (IUD).

A woman can switch from a mini-pill to Jeanine® on any day (without a break), from an implant or intrauterine contraceptive with a progestogen - on the day it is removed, from an injection form - from the day the next injection was to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.

· After an abortion in the first trimester of pregnancy

A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection.

· After childbirth or abortion in the second trimester of pregnancy

It is recommended to start taking the drug on the 21-28th day after childbirth or abortion. If the reception is started later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if a woman has already lived a sexual life, pregnancy should be excluded before taking Janine®, or it is necessary to wait for the first menstruation.

For information regarding the period of breastfeeding, see the section "Special Instructions"

Taking missed pills

If the delay in taking the drug was less than 12 hours, contraceptive protection is not reduced. The woman should take the missed tablet as soon as possible, as soon as she remembers, the next tablet is taken at the usual time.

If the delay in taking the tablets was more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:

· The drug should never be interrupted for more than 7 days.

· 7 days of continuous tablet intake are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

Accordingly, the following advice can be given in daily practice if the delay in taking the tablets was more than 12 hours (the interval from the moment of taking the last tablet is more than 36 hours).

· First week of taking the drug

The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next tablet is taken at the usual time. Additionally, a barrier method of contraception (such as a condom) must be used for the next 7 days. If sexual intercourse took place during the week before missing the tablet, the reliability of the drug is reduced, so the likelihood of pregnancy must be taken into account.

As the number of missed pills increases and the regular break period approaches, the chance of pregnancy increases.

· Second week of taking the drug

The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next tablet is taken at the usual time.

If the woman has taken the pills correctly in the 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as if you miss two or more tablets, you must additionally use barrier methods of contraception (for example, a condom) for 7 days.

· Third week of taking the drug

The risk of reduced reliability is inevitable due to the upcoming break in taking pills. However, the weakening of contraceptive protection can still be prevented by adjusting the pill schedule. Therefore, by adhering to one of the two schemes proposed below, additional protection measures can be dispensed with, provided that within 7 days before the first tablet was missed, the woman took all the tablets correctly. Otherwise, she should be advised to use the first of the following regimens and, in parallel, use additional methods of contraception for 7 days.

1. The woman should take the last missed pill as soon as she remembers (even if it means taking two pills at the same time). She then continues to take her tablets at the usual time. The next pack should be started immediately after the completion of taking the tablets from the current pack, that is, without interruption in taking the pills. Withdrawal bleeding is unlikely until the second pack is finished, but spotting and breakthrough bleeding may occur while taking the tablets.

2. The woman may also stop taking the pills from the current package. Then she should take a break for 7 days, including the day she missed the pill, and then start taking a new pack.

If a woman misses a pill and then does not have withdrawal bleeding during the pill break, pregnancy should be ruled out.

Changing the start date of the menstrual cycle

In order to delay the onset of menstruation, a woman should continue taking the tablets from the new Jeanine® package immediately after all the tablets from the previous one have been taken, without interruption in taking. Tablets from a new package can be taken for as long as the woman wishes (until the package runs out).

While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Janine® from a new pack after the usual 7-day break.

In order to move the day of the start of menstruation to another day of the week, a woman is advised to shorten the duration of the next break in taking pills by as many days as she wishes. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and subsequently spotting and breakthrough bleeding during the second pack (same as if she would like to delay the onset of her period).

Additional information for special categories of patients

Children and teenagers

Elderly patients

Not applicable. Jeanine® is not indicated after menopause.

Patients with liver disorders

Jeanine® is contraindicated in women with severe liver disease (See also section "Contraindications").

Side effects

The following is the frequency of side effects while taking Janine®, based on data from clinical studies:

Often (≥1/100,<1/10)

Headache

Breast pain, including discomfort and tightness

mammary glands

Uncommon (≥1/1000,< 1/100)

Vaginitis/vulvovaginitis, vaginal candidiasis, or other fungal vulvovaginal infections

increased appetite

Decreased mood

Dizziness, migraine

Arterial hypertension and hypotension

Pain in the abdomen, including in the upper and lower sections, discomfort and a feeling of "bursting" in the abdomen, nausea, vomiting, diarrhea

Rash, including patchy and acne, alopecia, itching, including generalized

Vaginitis/vulvovaginitis, vaginal candidiasis or others

Pathological withdrawal bleeding, including menorrhagia, hypomenorrhea, oligomenorrhea, amenorrhea, intermenstrual bleeding (vaginal or uterine), enlargement of the mammary glands, including swelling and flushing, swelling of the mammary glands, dysmenorrhea, discharge from the genital tract; ovarian cysts, pelvic pain

Fatigue, including malaise and asthenia

Weight gain

Rarely (≥1/10,000,<1/ 1000)

Hypersensitivity reactions

Salpingo-oophoritis, urinary tract infections, cystitis, mastitis, cervicitis, fungal infections, candidiasis, influenza, oral herpes, bronchitis, sinusitis, upper respiratory tract infections, viral infection

Uterine leiomyoma, breast lipoma

virilization

Anorexia

Depression, mental disorders, insomnia, sleep disorders, aggression

Ischemic stroke, cerebrovascular disorders, dystonia

Dry eyes, eye irritation, blurred vision, oscillopsia

Sudden hearing loss, tinnitus, vertigo, hearing loss

Cardiovascular disorders, tachycardia

Venous thromboembolism (VTE), arterial thromboembolism, pulmonary embolism, thrombophlebitis, diastolic

hypertension, orthostatic circulatory dysregulation, hot flashes, varicose veins, vein changes, vein pain

Bronchial asthma, hyperventilation

Dyspepsia, gastritis, enteritis

Allergic dermatitis, atopic dermatitis/neurodermatitis, eczema, psoriasis, hyperhidrosis, chloasma, pigmentation disorders/hyperpigmentation, seborrhoea, dandruff, hirsutism, skin reactions and skin changes, orange skin symptom, spider nevus

Back pain, musculoskeletal discomfort, myalgia, pain in extremities

Cervical dysplasia, adnexal cyst, adnexal pain, breast cyst, fibrocystic breast disease, genital pain associated with intercourse, galactorrhea, menstrual irregularities

Chest pain, peripheral oedema, influenza-like illness, inflammatory disease, pyrexia, irritability

Elevated plasma triglycerides, hypercholesterolemia, weight loss, changes in body weight

Manifestation of an asymptomatic accessory breast

With an unknown frequency (revealed only in the process of post-marketing observations)

Mood changes, decreased libido, increased libido

contact lens intolerance

Urticaria, erythema nodosum, erythema multiforme

Discharge from the mammary glands

Fluid retention

Description of individual adverse reactions

The following adverse reactions have been observed in women using combined oral contraceptives, which are also described in the "Special Instructions" section:

The frequency of breast cancer diagnosis is slightly increased among women taking oral contraceptives. Since breast cancer is rare in women under 40 years of age, the increase in the number of diagnoses is small in relation to the overall risk of developing this disease. Its relationship with the use of combined oral contraceptives has not been proven.

Liver tumors (benign and malignant)

Cervical cancer

Other states

Women with hypertriglyceridemia have an increased risk of developing pancreatitis while taking combined oral contraceptives.

Arterial hypertension

The appearance or worsening of the following conditions, the relationship of which with the use of combined oral contraceptives has not been proven: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnancy, hearing loss associated with otosclerosis

In women with hereditary angioedema, provoking or exacerbating symptoms of the disease under the influence of exogenous estrogens

Liver dysfunction

Impaired glucose tolerance or effects of peripheral insulin resistance

Crohn's disease and ulcerative colitis

Chloasma

Interactions

Breakthrough bleeding and / or a decrease in the contraceptive effectiveness of the drug due to interactions of combined oral contraceptives with drugs (liver enzyme inducers)

Contraindications

Combined hormonal contraceptives should not be used in the presence of any of the conditions listed below. If any of these conditions develop for the first time while taking a combined hormonal contraceptive, the drug should be immediately discontinued.

Presence or risk of venous thromboembolism

current (on anticoagulant therapy) or history of venous thromboembolism (eg, deep vein thrombosis, or pulmonary embolism)

hereditary or acquired predisposition to venous thromboembolism (for example, resistance to activated protein C (including factor V Leiden), deficiency of antithrombin III, protein C, or protein S

major surgical interventions with prolonged immobilization

high risk of venous thromboembolism due to the presence of multiple risk factors (See also the section "Special Instructions").

Presence or risk of arterial thromboembolism

current or previous arterial thromboembolism (eg, myocardial infarction) or conditions prior to arterial thromboembolism (eg, angina pectoris)

cerebrovascular disease - current or history of stroke, or conditions prior to cerebrovascular disease (eg, transient ischemic attacks)

hereditary or acquired predisposition to arterial thromboembolism (for example, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant)

migraine with a history of focal neurological symptoms

high risk of developing arterial thromboembolism due to the presence of multiple risk factors, such as:

Diabetes mellitus with vascular complications

Severe arterial hypertension

Severe dyslipoproteinemia

Pancreatitis with severe hypertriglyceridemia at present or in history.

Current or history of severe liver disease (before normalization of liver tests)

Liver tumors (benign or malignant) at present or in history

Identified or suspected hormone-dependent malignant diseases (for example, genital or mammary glands)

Unexplained vaginal bleeding

Hypersensitivity to any of the components of the drug

Drug Interactions

When prescribing concomitant therapy, the drug interactions section of each prescribed drug should be reviewed to identify potential interactions.

Effects of other drugs on Janine â

Interactions with drugs that induce liver enzymes are possible, which may increase the clearance of sex hormones and lead to breakthrough bleeding and / or a decrease in the contraceptive effectiveness of the drug.

Enzyme induction can be observed after a few days of treatment. Maximum enzymatic induction usually occurs within a few weeks. After stopping treatment, enzyme induction may persist for up to 4 weeks.

Short course of treatment

For women on a short course of treatment with liver enzyme-inducing drugs, it is recommended to use a barrier method of contraception in addition to Jeanine® or choose another method of contraception. In this case, the barrier method of contraception should be used during the period of concomitant use of drugs and within 28 days after their withdrawal. If the period of using the barrier method of protection ends later than the tablets in the Jeanine package, you need to move on to the next Jeanine package. â without the usual break in taking the pills.

Long course of treatment

Women on long-term treatment with liver enzyme-inducing drugs are advised to use another reliable, non-hormonal method of contraception.

Jeanine's influence ® for other drugs

Combined oral contraceptives can affect the metabolism of other drugs, resulting in an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in their plasma and tissue concentrations.

However, based on the data of in vitro studies, it is unlikely that the inhibition of enzymes of the cytochrome P450 system will develop when dienogest is prescribed at a therapeutic dose.

Clinical data suggest that ethinylestradiol inhibits the clearance of CYP1A2 substrates, resulting in mild (eg, theophylline) or moderate (eg, tizanidine) elevations.

special instructions

The decision to prescribe Jeanine should be made on an individual basis, taking into account the woman's risk factors, in particular the development of venous thromboembolism and the assessment of the risk of developing venous thromboembolism while taking Jeanine in comparison with other combined hormonal contraceptives.

Precautions and Warnings

If any of the conditions / risk factors listed below are currently present, it is necessary to discuss with the woman the advisability of using Jeanine.

In the event of an increase or first manifestation of any of these conditions or risk factors, the woman should consult her physician, who may decide whether to discontinue Jeanineâ.

If venous thromboembolism (VTE) or arterial thromboembolism (ATE) is suspected or confirmed, combined hormonal contraceptives should be discontinued. If a woman is prescribed anticoagulant therapy, adequate contraception by an alternative method should be provided, given the teratogenic effect of anticoagulant therapy (coumarins).

· Circulatory disorders

Risk of venous thromboembolism

The use of any combined hormonal contraceptive increases the risk of VTE in patients compared to women who do not use them.

Preparations containing levonorgestrel, norgestimate and norethisterone have the lowest risk of developing VTE. It is not known how much risk Jeanine has compared to these low risk drugs.

The decision to use these drugs, rather than any other low-risk VTE drug, should only be made after discussion with the woman. This is necessary to ensure that the woman is aware of the risks of developing VTE with Jeanine and how her risk factors will affect this risk, and that the risk of VTE is maximum in the first year of use.

In addition, there is some evidence that an increased risk may occur when a combined oral contraceptive is restarted after a break of 4 weeks or more.

In women who do not use combined hormonal contraceptives and in the absence of pregnancy, VTE develops at a rate of 2 per 10,000 cases over 1 year. However, this risk can increase significantly depending on each woman's individual risk factors (see below).

The results of epidemiological studies have shown that among women using low-dose combined hormonal contraceptives (<0,05 мг этинилэстрадиола ВТЭ возникает у 9–12 из 10 000 женщин) в течение года.

It is estimated that out of 10,000 women taking combined hormonal contraceptives containing levonorgestrel, 6 cases develop VTE within 1 year.

Limited data from epidemiological studies suggest that the risk of VTE with CHCs containing dienogest may be similar to the risk with CHCs containing levonorgestrel.

The indicated incidence of VTE during the year is lower than expected during pregnancy and in the postpartum period.

Venous thromboembolism can be fatal in 1-2% of cases.

In women taking combined hormonal contraceptives, cases of thrombosis of other blood vessels, such as hepatic, mesenteric, renal, cerebral arteries and veins, as well as retinal vessels, have been extremely rarely reported.

Risk factors for venous thromboembolism

The risk of developing venous thromboembolic complications while taking combined hormonal contraceptives can increase significantly if a woman has additional risk factors, especially if there are multiple risk factors.

Zhanin's appointment is contraindicated if the woman has multiple risk factors that cause a high risk of developing venous thrombosis.

Consideration should be given to the possibility of an increased synergistic risk of thrombosis in women with a combination of several risk factors or a higher severity of one of the risk factors. In such cases, the increased risk may be greater than just the combined risk when all factors are considered. Combined hormonal contraceptives should not be prescribed in case of a negative risk/benefit ratio (see section "Contraindications").

Symptoms of venous thromboembolism (deep vein thrombosis and pulmonary embolism)

Risk of arterial thromboembolism

Data from epidemiological studies indicate an increased risk of developing ATE (myocardial infarction) or cerebrovascular disorders (eg, transient ischemic attacks, stroke).

Arterial thromboembolic processes can be fatal.

Symptoms of arterial thromboembolism

If the following symptoms appear, a woman should urgently pay attention to this and inform the doctor that she is using combined hormonal contraceptives.

Symptoms of cerebrovascular disorders may include:

sudden weakness or numbness of the face, upper and lower extremities, especially on one side of the body, sudden confusion, impaired speech or difficulty with perception; sudden blurred vision in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination, sudden severe or prolonged headache for no apparent reason, loss of consciousness or fainting with or without a seizure. Other signs of vascular occlusion can also be sudden pain, swelling or slight cyanosis of the extremities, symptoms of "acute abdomen".

Symptoms of myocardial infarction include:

pain, discomfort, pressure, heaviness, a feeling of constriction or fullness in the chest, in the arm or behind the sternum, a feeling of discomfort radiating to the back, cheekbones, larynx, arm, stomach, a feeling of fullness or fullness in the stomach, a feeling of suffocation, cold sweat, nausea , vomiting or dizziness, severe weakness, anxiety, shortness of breath, rapid or irregular heartbeat.

Risk factors for venous and arterial thromboembolism

The risk of developing thrombosis (venous and / or arterial), thromboembolic or cerebrovascular disorders increases:

With age (over 35 years);

Smokers (women should stop smoking if they intend to take COCs. Other methods of contraception are strongly recommended for women over 35 who continue to smoke);

If there is a family history (i.e. venous or arterial thromboembolism ever in a sibling or parent at a relatively young age before 50 years). If a hereditary predisposition is known or suspected, a woman should consult a doctor to decide on the possibility of taking combined oral contraceptives;

Obesity (body mass index more than 30 kg/m2). The risk increases with increasing BMI. It is especially important to consider the presence of other risk factors;

With dyslipoproteinemia;

With arterial hypertension;

With migraine;

With diseases of the heart valves;

With atrial fibrillation;

With prolonged immobilization, major surgery, any operation on the legs or major trauma. In these situations, it is advisable to stop the use of combined oral contraceptives (in the case of a planned operation, at least four weeks before it) and not resume taking within two weeks after the end of immobilization. Temporary immobilization, including air travel longer than 4 hours, may increase the risk of VTE, particularly in women with other risk factors.

To prevent an unplanned pregnancy, you must use another method of contraception.

If Jeanine has not been discontinued in advance, antithrombotic therapy should be considered.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.

Consideration should be given to the increased risk of thromboembolism during pregnancy and especially during the 6 weeks postpartum period.

Circulatory disturbances can also be seen in tumors, diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.

An increase in the frequency and severity of migraine during the use of combined oral contraceptives (which may precede cerebrovascular disorders) may be grounds for immediate discontinuation of these drugs.

The most significant risk factor for developing cervical cancer is a viral infection - persistent human papilloma (HPV). There are reports of some increase in the risk of developing cervical cancer with long-term use of combined oral contraceptives, but data remain conflicting about the extent to which this may be due to other factors, including screening for cervical pathology and characteristics of sexual behavior ( less frequent use of barrier methods of contraception).

A meta-analysis of 54 pharmaco-epidemiological studies demonstrated that there is a slightly increased relative risk (RR=1.24) of developing breast cancer diagnosed in women who are currently taking combined oral contraceptives. The increased risk gradually disappears within 10 years after stopping these drugs. Due to the fact that breast cancer is rare in women under 40 years of age, the increase in the number of cases of breast cancer in women who are currently taking combined oral contraceptives or have recently taken it is insignificant in relation to the overall risk of developing this disease. Its relationship with the use of combined oral contraceptives has not been proven. The observed increase in risk may be due to earlier diagnosis of breast cancer in women using combined oral contraceptives, the biological effects of combined oral contraceptives, or a combination of both factors. In women who have ever used combined oral contraceptives, earlier stages of breast cancer are detected than in women who have never used them.

In rare cases, against the background of the use of combined oral contraceptives, the development of benign liver tumors and, in even more rare cases, the development of malignant liver tumors was observed. In some cases, liver tumors can lead to life-threatening intra-abdominal bleeding. If women taking combined oral contraceptives develop severe pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding, the possibility of a liver tumor should be considered in the differential diagnosis.

Malignant tumors can be life-threatening or fatal.

Women should be warned that hormonal contraceptives do not protect against HIV infection (AIDS) and other diseases that transmit X Xia sexually.

Reduced efficiency

The effectiveness of combined oral contraceptives may be reduced by missing pills, gastrointestinal disturbances, or drug interactions.

Effect on the menstrual cycle

While taking combined oral contraceptives, irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the first months of use. Therefore, evaluation of any irregular bleeding should be done only after an adaptation period of approximately three cycles.

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy. It may include curettage.

Pregnancy and lactation

Janine® is not prescribed during pregnancy.

If pregnancy is detected while taking the drug, you should immediately stop taking it. However, extensive pharmaco-epidemiological studies have not revealed any increased risk of developmental defects in children born to women who received combined oral contraceptives before pregnancy or teratogenicity when combined oral contraceptives were taken through negligence in early pregnancy.

Animal studies have shown undesirable effects of the drug during pregnancy and lactation.

Lactation

Jeanine® should not be used until the nursing mother has completely weaned her baby.

Children and teenagers

The drug Janine® is indicated only after the onset of menarche.

Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms.

Release form and packaging

21 tablets in a blister pack made of PVC film and aluminum foil.

1 blister pack, together with instructions for medical use in the state and Russian languages, is placed in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 25o C.

Keep out of the reach of children!

Shelf life

Do not use after the expiration date.

Content

Contraceptives and not only from the German manufacturer Bayer Schering Pharma are well known to the Russian buyer. These are new and high-quality drugs, the action of which has been tested in the brand's own laboratories. Instructions for use Jeanine describes in detail the composition, properties and rules of use, and also contains recommendations for additional means of protection against unplanned pregnancy.

Composition Jeanine

The drug is based on two hormonal components: ethinyl estradiol and dienogest, 0.03 and 2 mg, respectively. As additional components responsible for the shape, consistency and shelf life are: starch, wax, sucrose, gelatin, magnesium stearate and others.

Ethinylestradiol is a laboratory-synthesized analogue of the female sex hormone estrogen. Its structure completely repeats the natural, but in action it is much more active than natural. In combination with a gestogen, it is used as a combined contraceptive, and separately - as a treatment for endometriosis, ovarian dysfunction, and certain types of malignant tumors.

Dienogest is the second synthetic hormone, an analogue of progesterone. In pharmacological practice, it is almost always combined with estrogen, as it acts in a complex way to solve the problem. A separate application is indicated for the treatment of acne and acne in short courses.

Pharmacotherapeutic group and properties

Jeanine is a combined oral contraceptive of a low-dose monophasic type. This means that it contains small doses of sex hormones that must be taken during a special period of the cycle. Simply put, this is COC (estrogen + progestogen).

The instructions for use say that the property of the drug, as a contraceptive, is based on the mechanism of action of low doses of hormones. In combination, they suppress the processes of maturation and release of the egg into the fallopian tube for fertilization. Instructions for use explain that in addition hormones contribute to the thickening of the cervical fluid, which is a natural barrier to the penetration of spermatozoa into the uterus. Thus, a double contraceptive effect is achieved.

Additionally, in women who use Jeanine, the menstrual cycle is evened out, menstruation comes stably on the same day of the calendar, and the unpleasant symptoms of PMS go away. Menstruation becomes scarce, blood loss is minimal, which means that the risk of anemia also decreases.

Important! Instructions for use indicate that in parallel there is an improvement in the condition of the skin and hair, acne and acne disappear, and the emotional state improves.

According to scientists, with the correct systematic use of the drug, the risk of unwanted pregnancy is less than 1 in 100 women. This information is also reflected in the instructions for use in the form of a Pearl Index index, which is equal to 0.1-1.

Pharmacokinetics

Since the instructions for the drug Jeanine indicate two main active ingredients, their absorption, bioavailability and excretion should be considered separately.

So after ingestion, the substance dienogest quickly changes. In its pure form in the bloodstream it is an insignificant amount - less than 10%. The maximum concentration of metabolites is reached 2.5 hours after ingestion. From the stomach, substances enter the bloodstream and combine with whey proteins. The protective effect lasts more than 20 hours.

Instructions for use indicate that the half-life of dienogest metabolites is 10-14 hours. Part of the metabolites is excreted through the gastrointestinal tract, part by the kidneys.

Ethinylestradiol is rapidly and completely absorbed in the gastrointestinal tract after taking the dragee. Its maximum concentration is reached after 3 hours, and bioavailability remains at a low level - 44%.

Partly the substance is metabolized in the liver, partly in the small intestine. In its pure form, it is not present in the body. According to the instructions for use, it is excreted in the bile and urine within 20 hours.

Indications and contraindications for contraceptive pills Jeanine

In order for the effect of taking the drug to be maximum, and the negative consequences to be minimal, it is important to take into account all contraindications to its use. Instructions for use indicate the following contraindications:

thromboembolism, thrombosis, varicose veins;
diabetes;
migraine;
pancreatitis;
liver tumor;
diseases of the pancreas, including pancreatitis;
pregnancy and lactation;
individual intolerance to the components;
hormone-dependent tumors of internal organs.

It is forbidden to use the drug if a woman has had a stroke or heart attack, suffers from angina pectoris, coronary heart disease, hypertension. Instructions for use do not recommend the use of Jeanine, actively smoking women after 35 years of age. Start the next day after removing the coil, patch or taking a COC tablet.

Advice! After an abortion or miscarriage, Janine should be taken the next day or after consulting a doctor.

From the indications, the instruction for Janine indicates contraception, although gynecologists sometimes, with hormonal imbalances, irregular periods and acne, prescribe short courses of the drug to stabilize the condition.

Instructions for use of Jeanine tablets

Each pack of the drug contains 21 tablets. The instructions for use explain that the use of a contraceptive is designed for 3 weeks with a break of 7 days for the expected period. Thus, each new pack will be started on the same day of the week, unless the woman changes the interval in order to speed up or delay her period. Take the dragee should be strictly at the same time of the day, following the arrow on the package. The instruction warns that skipping the next dose reduces protection against pregnancy.

How to take Jeanine

The instructions for use say that this contraceptive refers to monophasic COCs. This means that there is a break in his intake, which should coincide with the monthly menstruation. Each tablet should be taken after meals with water. To minimize discomfort in the abdomen, dragees are taken in the evening before bedtime. Usually, the doctor determines the regimen, especially when it comes to switching from one COC to another.

How to take Janine for the first time

If a woman has not previously used hormonal contraceptives, Janine should be taken on the first day of menstruation. Then follow the direction of the arrow on the package and take the remaining 20 tablets. The instructions say that if the first pill was taken not on the first, but on the 2-5th day of menstruation, other means of protection against pregnancy are additionally used, for example, a condom. The instruction emphasizes when the last dragee from the package is drunk, take a 7-day break. During this period, menstruation should occur, as a reaction to the abolition of a dose of hormones. Usually, menstruation occurs 2-3 days after the cancellation.

When the 7-day break passes, in any case, they start taking dragees from the second pack. The instructions say that the drug is taken even if menstrual bleeding continues.

If the woman used other COCs, used a patch or coil, Janine

If, for any reason, a woman interrupted taking a pill, she should be taken as soon as possible, and the next one should be taken at the usual time, even if the interval between two pills is several hours.

Why does blood start if you drink Janine

In the first 2-3 months of taking COCs, 40% of women experience light spotting. This is a consequence of the adaptation of the body to a different hormonal regimen. The mechanism of the appearance of blood is complex and depends on what day of the cycle occurs. If in the first days of taking the dragee - this is the result of a lack of estrogen, if at the end - progesterone. Gradually, the reproductive system will get used to the action of the drug and spotting will stop.

The instructions say that if the discharge of blood increases, the woman feels pain in the lower abdomen, a doctor's consultation is necessary or a decision is made to stop using COCs. Each individual case is individual.

Side effects of Jeanine

In fact, the list of side effects of Jeanine is quite large. This drug is well studied, so the instructions indicate all the possible consequences of its use.

The most common side effects are:

headache and epigastric pain;
spotting not according to plan;
migraine;
change in the level of blood pressure;
deterioration in mood;
swelling and soreness in the mammary glands.

A woman may experience increased appetite, nausea, and vaginal discharge. There may be swelling and weight fluctuations.

drug interaction

With the simultaneous use of Jeanine and drugs from the list below, the protective function of COCs may weaken:

antibiotics;
drugs for the treatment of HIV infection, epilepsy, tuberculosis;
herbal preparations from St. John's wort;
antifungal drugs;
antidepressants.

The instruction warns that Jeanine is able to change the metabolism of cyclosporine.

Jeanine and alcohol

Instructions for use do not indicate the specific relationship of the drug Jeanine with alcohol. However, gynecologists recommend refraining from drinking alcohol-containing drinks 3 hours before and 3 hours after taking the dragee.

Special instructions and precautions

Taking COCs, including Jeanine, increases the risk of thrombosis. To minimize this risk, a woman is advised to stop smoking, especially if she is 35 years of age or older. This is official information from the instructions for use. If a woman feels severe pain in the lower abdomen, which is accompanied by heavy bleeding, the drug is canceled.

If after taking the dragee there was vomiting, the effectiveness of the tablets is reduced. Instructions for use recommend that women with chloasma limit the time spent in the sun while using dragees.

If menstrual bleeding is absent for 2 months in a row, it is important to consult a doctor to exclude or confirm pregnancy.

Terms and conditions of storage

The shelf life of the contraceptive is 3 years. Store the packaging at room temperature at a temperature not exceeding 25°C.

The price of Jeanine tablets

You can buy pills only with a doctor's prescription. The cost of 1 course of the drug is about 1000 rubles.

Jeanine's analogs

A composition identical to Jeanine is used in the following preparations:

Justinda;
Denovel;
Silhouette;
Naadin;
Julidora.

These are analogues of the drug Janine, in which the dosage of dienogest and ethinyl estradiol is also the same. The most affordable is the Hungarian Silhouette, the most expensive is the German Denovel.

Jeanine or Silhouette: which is better

Choosing a contraceptive is a completely individual matter. The body of every woman reacts in a special way to interventions in its hormonal status. It is possible to evaluate which remedy is more effective only after its personal use. Judging by the reviews of women after 30 about Janine, many people use it without serious side effects.

Almost everyone notes a period of adaptation, during which there is spotting and even bleeding. The instructions for use explain that the cycle stabilizes on average by 4 months.

A small percentage of women entered the group with serious side effects. This is thrombosis and severe abdominal pain. If the use of this COC greatly affects your well-being, you most likely need to select a remedy with a different dosage of hormones.

Jeanine or Yarina: which is better

These are the two most popular drugs in Russia. They are preferred by more than half of women of reproductive age. When choosing a remedy, take into account the fact that Yarina has a decongestant component in the composition and prevents fluid retention in the body. If a woman is prone to hormone-dependent edema, Yarina is preferable for her. This is stated in the instructions. In addition, this COC rarely gains weight, on the contrary, they lose weight. This information is obtained from numerous reviews about the drug.

Jess or Janine: which is better

The drugs differ in composition, in addition to ethinylestradiol, they contain dienogest and drospirenone. In medical practice, dienogest has a more pronounced therapeutic effect. Therefore, Jeanine is often prescribed for the treatment of women's diseases from endometriosis to severe PMS and unstable menstrual cycles. If there are no such problems, any of these drugs will do. The main thing is to exclude individual intolerance, but this is only in the process of admission.

Jeanine is a new generation hormonal contraceptive for systemic use. The action of the drug is aimed at inhibiting the secretion of gonadotropic pituitary hormones, inhibiting the maturation of follicles and suppressing ovulation.

The contraceptive effect of Zhanin is due to the suppression of ovulation, an increase in the viscosity of the cervical secret, a change in the endometrium, which reduces the possibility of implantation of a fertilized egg.

Active ingredient: 1 dragee contains ethinylestradiol 30 mcg, dienogest 2 mg.

Ethinylestradiol is a synthetic estrogen hormone that is normally produced in women by the ovaries and adrenal cortex. When administered orally to the body, it performs all the functions of endogenous (own) estrogen. After oral administration, ethinylestradiol is rapidly and completely absorbed. It is not excreted from the body unchanged. Metabolites of ethinylestradiol are excreted in the urine and bile in a ratio of 4:6.

Dienogest can be called an analogue of natural progesterone, this compound has antiandrogenic activity and improves the blood lipid profile (increases HDL). Dienogest is almost completely metabolized. A small part of dienogest is excreted by the kidneys in an unchanged state.

Indications for use Jeanine

Oral contraception (prevention of unwanted pregnancy);
Acne (acne), seborrhea;
hirsutism;
Androgenetic alopecia.

According to the instructions, Jeanine is recommended to be taken by women who live a regular sexual life to prevent unwanted pregnancy. The action of the drug is not limited to the contraceptive effect. The intake of Jeanine dragees is accompanied by the normalization of the menstrual cycle, a decrease in the pain of menstruation and the intensity of discharge, which significantly reduces the risk of developing anemia associated with iron deficiency.

Sometimes when taking the drug, there were cases of a decrease in the manifestations of endometriosis.

Instructions for use Jeanine, dosage

Dragee should be taken orally in the order indicated on the package, every day at about the same time, with a small amount of water. Jeanine should be taken 1 tablet / day. continuously for 21 days.

Taking tablets from each subsequent package should be started after a seven-day break in taking the drug, during which withdrawal bleeding (menstrual-like bleeding) should occur. It usually starts on the 2-3rd day after taking the last pill and may not end before the start of a new package.

With irregular use, the therapeutic and / or contraceptive effect after Zhanin may be reduced, for this reason it is important not to forget about taking the drug in a timely manner. The permissible delay in taking Janine is 12 hours. The next dragee is taken at the usual time.

Application features

Before starting or resuming the use of the drug Janine, it is recommended to take a complete medical history (including family history) and exclude pregnancy.

For children and adolescents, Jeanine is indicated only after the onset of menarche.

After the onset of menopause, the drug Jeanine is not used.

The intake of alcohol and fatty foods does not affect the action of the hormonal drug. No contraindications for driving vehicles and working with precise mechanisms have been identified.

Side effects and contraindications of Jeanine

soreness and tension of the mammary glands, their increase, swelling and the appearance of discharge from the nipples;
spotting and breakthrough uterine bleeding;
headache, including migraine;
a change in libido (both a decrease in desire and an increase in interest in sexual intercourse);
decrease / mood changes, drops, emotional jumps;
poor tolerance to contact lenses;
visual impairment;
nausea;
vomit;
pain in the epigastric region;
changes in vaginal secretion;
skin rash, urticaria;
erythema nodosum;
erythema multiforme;
generalized itching;
cholestatic jaundice;
fluid retention in the tissues, the appearance of swelling;
change in body weight, both upward and downward;
allergic reactions.

Rarely, there is an increase in plasma triglyceride levels, a decrease in carbohydrate tolerance, increased fatigue, and diarrhea.
Against the background of taking combined oral contraceptives in women, other undesirable effects were observed.

Overdose

Symptoms: nausea, vomiting, spotting (mucus, clots, blood particles, etc.) or metrorrhagia. Serious violations in case of overdose have not been reported.

Treatment: symptomatic treatment. There is no specific antidote.

Contraindications

the presence of thrombosis at the time of admission or in history;
migraine with focal neurological symptoms at present or in history;
the presence at the time of admission or in the anamnesis of signs indicating future thrombosis (example: transient ischemic attacks, angina pectoris);
diabetes mellitus with vascular complications;
the presence of a sufficient number of reasons for the occurrence of venous or arterial thrombosis;
the presence at the time of admission or a history of jaundice or dangerous liver pathologies (until the liver recovers);
pancreatitis with severe hypertriglyceridemia at present or in history;
the presence at the time of admission or a history of benign or cancerous liver pathologies;
calculated hormone-dependent cancerous pathologies of the genitals or mammary glands or the likelihood of their presence;
discharge of blood from the vagina of unknown origin;
pregnancy or its symptoms;
lactation period;
individual intolerance to any components of the contraceptive.

Jeanine's analogues, list of drugs

Jeanine's analogues by action and scope, list:

Midian;
Diana-35;
Regulon;
Marvelon;
Yarina;
Lindinet 30;
Levonorgestrel;
Mirena;
Lactinet;
Postinor.

It is important to understand that the instructions for the use of Jeanine tablets, the price and reviews do not apply to analogues and cannot be used for self-treatment, prescription or other therapeutic actions. Replacing Jeanine with an analogue should be carried out by a specialist, dosage adjustment may be required. Before using the drug, it is important to consult a doctor.

Jeanine is the choice of those who want to prevent unwanted pregnancy without using a condom and other local contraceptives and also solve a number of other problems, for example, reduce the manifestations of endometriosis. Like any drug, Jeanine has side effects and contraindications. An experienced gynecologist will help to weigh all the pros and cons, a visit to which is a must before taking medicinal dragees!

Dosage form

Sugar-coated tablets

Compound

One tablet contains

active substances: ethinylestradiol 0.03 mg,

dienogest 2.0 mg,

excipients: lactose monohydrate, corn starch, maltodextrin, magnesium stearate,

shell composition: sucrose, liquid glucose, calcium carbonate, povidone K 25, macrogol 35000, titanium dioxide (E 171), carnauba wax.

Description

Smooth, white, sugar-coated tablets, round shape

Pharmacotherapeutic group

Sex hormones and modulators of the reproductive system.

Hormonal contraceptives for systemic use.

Progestogens and estrogens (fixed combination). dienogest and estrogen.

ATX code G03AA16

Pharmacological properties

Pharmacokinetics

Dienogest

Absorption

After oral administration, dienogest is rapidly and almost completely absorbed, its maximum serum concentration of 51 ng / ml is reached after about 2.5 hours. Bioavailability in combination with ethinyl estradiol is approximately 96%.

Distribution

Dienogest binds to serum albumin and does not bind to sex hormone-binding globulin (SHBG) and corticoid-binding globulin (CBG). In the free form is about 10% of the total concentration in the blood serum; about 90% - non-specifically associated with serum albumin. The induction of SHBG synthesis by ethinylestradiol does not affect the binding of dienogest to whey protein. The apparent volume of distribution for dienogest is approximately 37-45 L/kg.

Metabolism

Dienogest is metabolized predominantly by hydroxylation and conjugation to form inactive metabolites. These metabolites are rapidly excreted from the blood plasma, thus, no active metabolite is noted in the plasma, and only dienogest is found in an unchanged state. The total clearance is about 3.6 l / h after a single application.

breeding

A decrease in the level of dienogest in the blood serum occurs with a half-life of about 9 hours. Only a small part of dienogest is excreted by the kidneys in an unchanged state. When administered at a dose of 0.1 mg per kg of body weight, metabolites are excreted in the urine and bile in a ratio of about 3:2. After oral administration, approximately 86% of the received dose is excreted within 6 days, with the main part, 42%, excreted in the first 24 hours, mainly with urine.

Equilibrium concentration

The pharmacokinetics of dienogest does not depend on the level of SHBG. As a result of daily administration of the drug, the level of dienogest in serum increases by about 1.5 times, and the equilibrium concentration is reached after 4 days of administration.

Ethinylestradiol

Absorption

After oral administration, ethinylestradiol is rapidly and completely absorbed. The maximum concentration in blood serum, equal to approximately 67 pg / ml, is reached in 1.5-4 hours. During absorption and first passage through the liver, ethinyl estradiol is metabolized, resulting in an average oral bioavailability of about 44%.

Distribution

Ethinylestradiol is almost completely (approximately 98%), although non-specific, bound to albumin. Ethinylestradiol induces the synthesis of SHBG. The apparent volume of distribution of ethinylestradiol is 2.8 - 8.6 l / kg.

Ethinylestradiol undergoes presystemic conjugation both in the small intestine mucosa and in the liver. Ethinylestradiol is primarily metabolized by aromatic hydroxylation, producing various hydroxylated and methylated metabolites, both as free metabolites and as conjugates with glucuronic and sulfuric acids. The rate of clearance from blood plasma is 2.3 - 7 ml / min / kg.

breeding

The decrease in the concentration of ethinylestradiol in the blood serum is biphasic; the first phase is characterized by a half-life of about 1 hour, the second - 10-20 hours. It is not excreted from the body unchanged. Metabolites of ethinylestradiol are excreted in the urine and bile in a ratio of 4:6 with an elimination half-life of about 24 hours.

Equilibrium concentration

Pharmacodynamics

All hormonal contraceptives have a very low "method failure" rate when used according to the instructions for use (for example, when pills are missed).

In clinical studies, the following Pearl Index was calculated.

The Pearl Index (adjusted) for estimating "method failure" is 0.182 (upper two-tailed 95% confidence interval: 0.358).

Overall Pearl Index (unadjusted, method failures + patient bias): 0.454 (upper two-tailed 95% confidence interval: 0.701).

Jeanine is an oral combined contraceptive preparation containing ethinyl estradiol and the progestogen dienogest.

The contraceptive effect of Jeanine® is based on the interaction of various factors, the most important of which are the inhibition of ovulation and changes in the secretion of cervical mucus.

Dienogest is a nortestosterone derivative with an in vitro affinity for progesterone receptors 10-30 times less than other synthetic progestogens.

In vivo animal data have demonstrated potent progestogenic and antiandrogenic activity.

Dienogest does not have significant androgenic, mineralocorticoid or glucocorticoid activity in vivo.

It has been established that dienogest contributes to the inhibition of ovulation at a dose of 1 mg per day.

Indications for use

Oral contraception (see section "Special Instructions")

Dosage and administration

How to start taking Janine®

In the absence of taking any hormonal contraceptives in the previous month

Janine® is started on the first day of the menstrual cycle (i.e. the first day of menstrual bleeding).

When switching from other combined oral contraceptives (COCs)

When switching from the vaginal ring, transdermal patch

It is preferable to start taking Janine® on the day of removal of the last ring or patch, but in no case later than the day when the next ring or patch should have been applied.

When switching from contraceptives containing only gestagens (mini-pill, injectable forms, implant) or from a progestogen-releasing intrauterine system (IUD).

After an abortion in the first trimester of pregnancy

A woman can start taking the drug immediately. If this condition is met, the woman does not need additional contraceptive protection.

After childbirth or abortion in the second trimester of pregnancy

For information regarding the period of breastfeeding, see the section "Special Instructions"

Taking missed pills

If the delay in taking the tablets was more than 12 hours, contraceptive protection may be reduced. In this case, you can be guided by the following two basic rules:

· The drug should never be interrupted for more than 7 days.

· 7 days of continuous tablet intake are required to achieve adequate suppression of hypothalamic-pituitary-ovarian regulation.

The first week of taking the drug

As the number of missed pills increases and the regular break period approaches, the chance of pregnancy increases.

The second week of taking the drug

The woman should take the last missed tablet as soon as she remembers (even if it means taking two tablets at the same time). The next tablet is taken at the usual time.

The third week of taking the drug

2. The woman may also stop taking the pills from the current package. Then she should take a break for 7 days, including the day she missed the pill, and then start taking a new pack.

If a woman misses a pill and then does not have withdrawal bleeding during the pill break, pregnancy should be ruled out.

In severe gastrointestinal disorders, the absorption of the drug may be incomplete. In this case, additional contraceptive measures should be taken.

If a woman vomits within 3-4 hours after taking the pill, it is necessary to focus on the advice regarding skipping pills. If a woman does not want to change the normal regimen of taking the drug, she should take an additional tablet if necessary (or 2 tablets from another package).

Changing the start date of the menstrual cycle

While taking the drug from the second package, a woman may experience spotting or breakthrough uterine bleeding. Resume taking Janine® from a new pack after the usual 7-day break.

Additional information for special categories of patients

Children and teenagers

Elderly patients

Not applicable. Jeanine® is not indicated after menopause.

Patients with liver disorders

Jeanine® is contraindicated in women with severe liver disease (See also section "Contraindications").

Patients with kidney disorders

Jeanine has not been specifically studied in women with impaired renal function. Available data do not suggest dose adjustment in this group of patients.

Side effects

The following is the frequency of side effects while taking Janine®, based on data from clinical studies:

Often (≥1/100,<1/10)

Headache

Breast pain, including discomfort and tightness

mammary glands

Uncommon (≥1/1000,<1/100)

Vaginitis/vulvovaginitis, vaginal candidiasis, or other fungal vulvovaginal infections

increased appetite

Decreased mood

Dizziness, migraine

Arterial hypertension and hypotension

Pain in the abdomen, including in the upper and lower sections, discomfort and a feeling of "bursting" in the abdomen, nausea, vomiting, diarrhea

Rash, including patchy and acne, alopecia, itching, including generalized

Vaginitis/vulvovaginitis, vaginal candidiasis or others

Fatigue, including malaise and asthenia

Weight gain

Rarely (≥1/10,000,<1/ 1000)

Hypersensitivity reactions

Uterine leiomyoma, breast lipoma

virilization

Anorexia

Depression, mental disorders, insomnia, sleep disorders, aggression

Ischemic stroke, cerebrovascular disorders, dystonia

Dry eye, eye irritation, blurred vision, oscillopsia

Sudden hearing loss, tinnitus, vertigo, hearing loss

Cardiovascular disorders, tachycardia

Venous thromboembolism (VTE), arterial thromboembolism, pulmonary embolism, thrombophlebitis, diastolic

hypertension, orthostatic circulatory dysregulation, hot flashes, varicose veins, vein changes, vein pain

Bronchial asthma, hyperventilation

Dyspepsia, gastritis, enteritis

Back pain, musculoskeletal discomfort, myalgia, pain in extremities

Cervical dysplasia, adnexal cyst, adnexal pain, breast cyst, fibrocystic breast disease, genital pain associated with intercourse, galactorrhea, menstrual irregularities

Chest pain, peripheral oedema, influenza-like illness, inflammatory disease, pyrexia, irritability

Elevated plasma triglycerides, hypercholesterolemia, weight loss, changes in body weight

Manifestation of an asymptomatic accessory breast

With an unknown frequency (revealed only in the process of post-marketing observations)

Mood changes, decreased libido, increased libido

contact lens intolerance

Urticaria, erythema nodosum, erythema multiforme

Discharge from the mammary glands

Fluid retention

Description of individual adverse reactions

The following adverse reactions have been observed in women using combined oral contraceptives, which are also described in the "Special Instructions" section:

Liver tumors (benign and malignant)

Cervical cancer

Other states

Women with hypertriglyceridemia have an increased risk of developing pancreatitis while taking combined oral contraceptives.

Arterial hypertension

In women with hereditary angioedema, provoking or exacerbating symptoms of the disease under the influence of exogenous estrogens

Liver dysfunction

Impaired glucose tolerance or effects of peripheral insulin resistance

Crohn's disease and ulcerative colitis

Chloasma

Interactions

Breakthrough bleeding and / or a decrease in the contraceptive effectiveness of the drug due to interactions of combined oral contraceptives with drugs (liver enzyme inducers)

Contraindications

Presence or risk of venous thromboembolism

current (on anticoagulant therapy) or history of venous thromboembolism (eg, deep vein thrombosis, or pulmonary embolism)

hereditary or acquired predisposition to venous thromboembolism (for example, resistance to activated protein C (including factor V Leiden), deficiency of antithrombin III, protein C, or protein S

major surgical interventions with prolonged immobilization

high risk of venous thromboembolism due to the presence of multiple risk factors (See also the section "Special Instructions").

Presence or risk of arterial thromboembolism

current or previous arterial thromboembolism (eg, myocardial infarction) or conditions prior to arterial thromboembolism (eg, angina pectoris)

cerebrovascular disease - current or history of stroke, or conditions prior to cerebrovascular disease (eg, transient ischemic attacks)

hereditary or acquired predisposition to arterial thromboembolism (for example, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies and lupus anticoagulant)

migraine with a history of focal neurological symptoms

high risk of developing arterial thromboembolism due to the presence of multiple risk factors, such as:

Diabetes mellitus with vascular complications

Severe arterial hypertension

Severe dyslipoproteinemia

Pancreatitis with severe hypertriglyceridemia at present or in history.

Current or history of severe liver disease (before normalization of liver tests)

Liver tumors (benign or malignant) at present or in history

Identified or suspected hormone-dependent malignant diseases (for example, genital or mammary glands)

Unexplained vaginal bleeding

Hypersensitivity to any of the components of the drug

Drug Interactions

When prescribing concomitant therapy, the drug interactions section of each prescribed drug should be reviewed to identify potential interactions.

Effects of other drugs on Janine â

Short course of treatment

For women on a short course of treatment with liver enzyme-inducing drugs, it is recommended to use a barrier method of contraception in addition to Jeanine® or choose another method of contraception. In this case, the barrier method of contraception should be used during the period of concomitant use of drugs and within 28 days after their withdrawal. If the period of use of the barrier method of contraception ends later than the pills in the Janine pack, you need to go to the next Janine pack without the usual break in taking the pills.

Long course of treatment

Women on long-term treatment with liver enzyme-inducing drugs are advised to use another reliable, non-hormonal method of contraception.

Substances that increase the clearance of combined oral contraceptives (reducing the effectiveness of combined oral contraceptives due to the induction of liver enzymes), for example:

phenytoin, barbiturates, primidone, carbamazepine and rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

Substances with different effects on the clearance of combined oral contraceptives

When combined with combined oral contraceptives, many inhibitors of HIV / HCV protease and non-nucleoside reverse transcriptase inhibitors can increase or decrease the concentration of estrogens or progestins in blood plasma. These changes may in some cases be relevant.

Therefore, it is necessary to read the instructions for use for medicinal products used in conjunction with Janine to identify potential interactions and prescribe any recommendations. Women receiving treatment with protease inhibitors or non-nucleoside reverse transcriptase inhibitors, if in doubt, should use an additional barrier method of contraception

Substances that reduce the clearance of combined oral contraceptives (enzyme inhibitors)

The clinical significance of potential interactions with enzyme inhibitors is unknown.

Co-administration with potent CYP3A4 inhibitors may increase plasma concentrations of estrogen or progestin, or both.

Etoricoxib at a dose of 60 to 120 mg / day increases the concentration of ethinylestradiol in plasma by 1.4-1.6 times when taken simultaneously with combined hormonal contraceptives containing 0.035 mg of ethinylestradiol.

Effect of Janine® on other drugs

Combined oral contraceptives can affect the metabolism of other drugs, resulting in an increase (eg, cyclosporine) or a decrease (eg, lamotrigine) in their plasma and tissue concentrations.

However, based on the data of in vitro studies, it is unlikely that the inhibition of enzymes of the cytochrome P450 system will develop when dienogest is prescribed at a therapeutic dose.

Clinical data suggest that ethinylestradiol inhibits the clearance of CYP1A2 substrates, resulting in mild (eg, theophylline) or moderate (eg, tizanidine) elevations.

Other forms of interaction

Laboratory tests

The use of contraceptive steroids may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma concentrations of proteins, for example, corticosteroid-binding globulins and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and coagulation parameters. Changes usually do not go beyond the boundaries of normal values.

special instructions

Precautions and Warnings

If any of the conditions / risk factors listed below are currently present, it is necessary to discuss with the woman the advisability of using Jeanine.

In the event of an increase or first manifestation of any of these conditions or risk factors, the woman should consult her physician, who may decide whether to discontinue Jeanineâ.

· Circulatory disorders

Risk of venous thromboembolism

The use of any combined hormonal contraceptive increases the risk of VTE in patients compared to women who do not use them.

Preparations containing levonorgestrel, norgestimate and norethisterone have the lowest risk of developing VTE. It is not known how much risk Jeanine has compared to these low risk drugs.

In addition, there is some evidence that an increased risk may occur when a combined oral contraceptive is restarted after a break of 4 weeks or more.

It is estimated that out of 10,000 women taking combined hormonal contraceptives containing levonorgestrel, 6 cases develop VTE within 1 year.

Limited data from epidemiological studies suggest that the risk of VTE with CHCs containing dienogest may be similar to the risk with CHCs containing levonorgestrel.

The indicated incidence of VTE during the year is lower than expected during pregnancy and in the postpartum period.

Venous thromboembolism can be fatal in 1-2% of cases.

Risk factors for venous thromboembolism

Zhanin's appointment is contraindicated if the woman has multiple risk factors that cause a high risk of developing venous thrombosis.

Symptoms of venous thromboembolism (deep vein thrombosis and pulmonary embolism)

Symptoms of deep vein thrombosis include the following:

unilateral swelling in the leg or along a vein in the leg, pain or discomfort in the leg only in an upright position or when walking, a local increase in temperature in the affected limb, redness or discoloration of the skin on the leg.

Symptoms of pulmonary embolism are as follows: the sudden onset of unexplained shortness of breath or rapid breathing, a sudden attack of coughing, which may be accompanied by hemoptysis, severe chest pain, which may worsen with deep breathing, anxiety, severe dizziness; fast or irregular heartbeat.

Some of these symptoms (eg, "shortness of breath" and "cough") are nonspecific and may therefore be misinterpreted as signs of more frequent and less severe disorders (eg, respiratory tract infections).

Other signs of vascular occlusion may include the following:

Sudden pain, swelling and blueness of the limb.

Occlusion of the vessels of the eyes may cause blurred vision, which may progress to loss of vision. In some cases, almost sudden loss of vision may occur.

Risk of arterial thromboembolism

Data from epidemiological studies indicate an increased risk of developing ATE (myocardial infarction) or cerebrovascular disorders (eg, transient ischemic attacks, stroke).

Arterial thromboembolic processes can be fatal.

Risk factors for ATE

The risk of developing arterial thromboembolic complications or cerebrovascular disorders while taking combined hormonal contraceptives increases if a woman has risk factors.

Zhanin's appointment is contraindicated if a woman has one significant factor or multiple risk factors that cause a high risk of developing arterial thrombosis.

Consideration should be given to the possibility of an increased synergistic risk of thrombosis in women with a combination of several risk factors or a higher severity of one of the risk factors.

In such cases, the increased risk may be greater than just the combined risk when all factors are considered. Combined oral contraceptives should not be prescribed in case of a negative risk/benefit ratio (see section "Contraindications").

Symptoms of arterial thromboembolism

If the following symptoms appear, a woman should urgently pay attention to this and inform the doctor that she is using combined hormonal contraceptives.

Symptoms of cerebrovascular disorders may include:

Symptoms of myocardial infarction include:

Risk factors for venous and arterial thromboembolism

The risk of developing thrombosis (venous and / or arterial), thromboembolic or cerebrovascular disorders increases:

With age (over 35 years);

Smokers (women should stop smoking if they intend to take COCs. Other methods of contraception are strongly recommended for women over 35 who continue to smoke);

Obesity (body mass index more than 30 kg/m2). The risk increases with increasing BMI. It is especially important to consider the presence of other risk factors;

With dyslipoproteinemia;

With arterial hypertension;

With migraine;

With diseases of the heart valves;

With atrial fibrillation;

To prevent an unplanned pregnancy, you must use another method of contraception.

If Jeanine has not been discontinued in advance, antithrombotic therapy should be considered.

The question of the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism remains controversial.

Consideration should be given to the increased risk of thromboembolism during pregnancy and especially during the 6 weeks postpartum period.

Malignant tumors can be life-threatening or fatal.

Other states

Women with hypertriglyceridemia (or a family history of this condition) may be at an increased risk of developing pancreatitis while taking Janine.

Although a slight increase in blood pressure has been described in many women taking combined oral contraceptives, clinically significant increases have been rare. However, if a persistent, clinically significant increase in blood pressure develops while taking Janine®, this drug should be discontinued and treatment of arterial hypertension should be started. Reception of Janine® can be continued if normal blood pressure values are achieved with the help of antihypertensive therapy.

The following conditions observed during pregnancy may also appear or worsen when taking combined oral contraceptives: jaundice and / or itching associated with cholestasis; the formation of stones in the gallbladder; porphyria; systemic lupus erythematosus; hemolytic uremic syndrome; chorea; herpes of pregnant women; hearing loss associated with otosclerosis. However, the relationship between the development of these conditions and the use of combined oral contraceptives has not been proven.

In women with hereditary angioedema, exogenous estrogens contained in the drug may provoke or exacerbate the symptoms of this disease.

In the presence of acute or chronic disorders of liver function, it is necessary to decide the issue of stopping the use of combined oral contraceptives until the indicators of liver function return to normal. With the development of recurrent cholestatic jaundice, which develops for the first time during pregnancy or previous use of sex hormones, you should stop taking combined oral contraceptives.

Although combined oral contraceptives may affect insulin resistance and glucose tolerance, there is no need to change the therapeutic regimen in diabetic patients using low-dose combined oral contraceptives (<0,05 мг этинилэстрадиола). Тем не менее, женщины с сахарным диабетом должны тщательно наблюдаться во время приема препарата Жанин®.

Against the background of the use of combined oral contraceptives, manifestations of Crohn's disease and nonspecific ulcerative colitis, as well as worsening of endogenous depression and epilepsy, were observed.

Occasionally, chloasma may develop, especially in women with a history of chloasma of pregnancy. Women with a tendency to chloasma while taking combined oral contraceptives should avoid prolonged exposure to the sun and exposure to ultraviolet radiation.

Women with a tendency to develop chloasma should avoid prolonged sun exposure and UV exposure while taking Janine®.

One tablet of Janine® contains 27 mg of lactose and 1.65 mg of glucose. In patients with rare hereditary disorders such as galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, who are on a lactose-free diet, the amount of lactose contained in the preparation should be taken into account.

Medical examinations

Before or resuming the intake of Jeanine, you should familiarize yourself in detail with the patient's medical history, including family history, and exclude pregnancy. Blood pressure should be measured and a physical examination should be performed, taking into account contraindications and warnings (see section "Special Instructions").

It is very important to draw the woman's attention to information about arterial and venous thromboembolism, including the risk of blood clots when taking Janine® in comparison with other CHPs; symptoms of venous and arterial thromboembolism; known risk factors and what to do if thrombosis is suspected.

The woman should be instructed to carefully read the instructions for use of the drug and follow the recommendations indicated in it.

The frequency and nature of examinations should be based on established practice guidelines and should be determined on an individual basis for each woman.

A woman should be warned that hormonal contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of combined oral contraceptives may be reduced by missing pills, gastrointestinal disturbances, or drug interactions.

Effect on the menstrual cycle

If irregular bleeding recurs or develops after previous regular cycles, a thorough examination should be carried out to exclude malignant neoplasms or pregnancy. It may include curettage.

Some women may not develop withdrawal bleeding during their pill break. If combined oral contraceptives were taken as directed, it is unlikely that the woman is pregnant. However, if previously combined oral contraceptives were taken irregularly or if there are no consecutive withdrawal bleedings, pregnancy should be excluded before continuing to take the drug.

Pregnancy and lactation

Janine® is not prescribed during pregnancy.

Animal studies have shown undesirable effects of the drug during pregnancy and lactation. Based on the data obtained in the course of these animal studies, an undesirable effect associated with the hormonal action of the active compounds of the drug cannot be excluded. However, general experience with combined oral contraceptives during pregnancy does not indicate actual adverse effects in humans.

An increased risk of developing venous thromboembolism should be taken into account when resuming Zhanin® in the postpartum period (see section "Special Instructions").

Lactation

Taking combined oral contraceptives affects lactation because they can reduce the amount of breast milk and change its composition. A small amount of sex steroids and / or their metabolites can be excreted in milk while taking combined oral contraceptives and affect the child's body.

Therefore, Jeanine® should not be used until the nursing mother has completely weaned her baby.

Children and teenagers

The drug Janine® is indicated only after the onset of menarche.

Features of the effect of the drug on the ability to drive vehicles and potentially dangerous mechanisms.

No research has been done.

The use of the drug does not affect the ability to drive vehicles and potentially dangerous mechanisms.

Overdose

The acute toxicity of ethinyl estradiol and dienogest is very low. For example, if a child accidentally takes several Jeanine® tablets at the same time, it is unlikely that this will lead to the development of symptoms of intoxication.

Symptoms: Nausea, vomiting and, in young girls, minor vaginal bleeding.

Shelf life

Do not use after the expiration date.

Terms of dispensing from pharmacies

On prescription

Manufacturer

Bayer Weimar GmbH & Co.KG, Germany

Jeanine is a low-dose monophasic combined oral contraceptive with an antiandrogenic effect. The drug contains ethinylestradiol and dienogest. Jeanine contraceptive pills are available in the form of dragees, the quantitative content of the drug in the package is 21 pcs.

Auxiliary components are: lactose, starch, gelatin, glucose, povidone, titanium dioxide.

Jeanine has a contraceptive effect by changing the viscosity of the mucus. When using the drug, ovulation is suppressed, and the cervical mucus becomes impermeable to spermatozoa.

Dienogest is a progestogen component of the drug Janine and contributes to the provision of antiandrogenic effects and improves the lipid profile of the blood. When using the drug, an increase in high-density lipoproteins (“good” cholesterol) is observed.

In patients who use low-dose monophasic oral contraceptives, including Janine, the development of such positive effects is observed:

The menstrual cycle is normalized.
Reducing the intensity and duration of bleeding.
Elimination of painful sensations during the next menstruation.
Reducing the risk of iron deficiency anemia.

According to the results of clinical studies, against the background of the use of Jeanine birth control pills, the number of cases of endometrial and ovarian cancer has decreased.

Indications for use

The main indication for the use of the drug Jeanine is the provision of a contraceptive effect.

Thanks to its multicomponent composition, Jeanine can be used in the complex therapy of breast diseases, including mastopathy.

Contraindications

The use of the drug Jeanine is contraindicated in the presence of one of the following conditions:

The development of thrombosis and thromboembolism (including the presence of these diseases in the patient's history), including pulmonary embolism, myocardial infarction, stroke, deep vein thrombosis and cerebrovascular disorders.

The presence of conditions that precede the development of thrombosis.

With migraine, which is accompanied by the development of focal neurological symptoms.

With diabetes mellitus, which is complicated by vascular disorders.

With pancreatitis, which is accompanied by severe hypertriglyceridemia.

With liver failure and severe liver disease. In case of normalization of liver tests, Janine can be taken with the approval of a doctor.

When identifying and hormone-dependent malignant neoplasms or if they are suspected.

With the development of bleeding from the vagina of unknown origin.

With increased sensitivity to the main or auxiliary components of the drug.

With the development of any of the listed diseases while taking the drug Jeanine, it is necessary to stop the use of the dragee and consult a doctor immediately.

Use with extreme caution

Jeanine should be used with extreme caution and after carefully balancing the potential benefit against the perceived risk in the presence of the following conditions:

Risk factors that may contribute to the development of thrombosis: smoking, obesity, arterial hypertension, migraine, major surgery, heart valve disease, hereditary predisposition to the development of thrombosis.
Other diseases that can contribute to the development of peripheral circulatory disorders: diabetes mellitus, Crohn's disease and ulcerative colitis, lupus erythematosus, sickle cell anemia.
With hereditary angioedema.
With an increased level of triglycerides in the blood plasma.
With liver diseases.
In the postpartum period.

Use during pregnancy and breastfeeding

If pregnancy is suspected, as well as during breastfeeding, the use of Jeanine is contraindicated.

In the event that pregnancy is detected during the use of the drug Janine, the drug should be stopped immediately.

According to the results of extensive epidemiological studies, there was no increased risk of developing any defects in children whose mother took sex hormones before pregnancy.

There is also no increased risk of developing toxic effects if the drug was taken through negligence at an early stage of pregnancy.

When using the drug Jeanine during lactation, the risk of a decrease in the amount of breast milk increases and its composition changes. Sex steroids or their compounds can be excreted in breast milk.

Mode of application

Jeanine must be taken in the order indicated by the numbers on the package. Reception of a dragee is carried out daily, approximately at the same time of day. The medicine should be taken with a small amount of water.

Dragees are taken without interruption for 21 days. Reception of the next package can begin after a 1-week break. During this time, withdrawal bleeding should develop. Bleeding begins a few days after taking the last pill.

How to start taking the drug

In the event that in the previous month there was no intake of any hormonal drugs, then Janine's medication should begin on the first day of the menstrual cycle. As needed, you can start taking pills in the period from 2 to 5 days of the cycle, but in this case there is a need to use barrier methods of contraception.

In the event that a transition is made from other contraceptives (this group includes combined oral contraceptives, vaginal rings and transdermal patches), then Janine should be taken the next day after taking the last pill from the previous package.

If switching from vaginal rings or transdermal patches, Janine should be started on the day the ring is removed or the patch is removed.

When switching from contraceptives, which contain only gestagens (these include Mirena, mini-drank), then Zhanin's reception can begin on any day. In this case, the use of barrier methods of contraception for 1 week is required.

How to take the missed dragee?

In the event that the drug was missed, then additional recommendations must be followed.

If the skip time is less than 12 hours, then the contraceptive effect of the drug will not decrease. In this case, you should take the drug as soon as possible. Further reception is carried out according to the usual scheme.

If the skip time is more than 12 hours, then the contraceptive effect is reduced. In this case, the use of dragees should not be suspended for more than 1 week. In order to suppress the hypothalamic-pituitary-ovarian regulation, 1 week of continuous medication is required.

Pass at 1 week of admission. Taking the drug in the first week should be carried out as soon as possible, even if this means taking two tablets at once. Further reception is carried out according to the usual scheme. In the future, it is necessary to use barrier methods of contraception for the next 7 days.
Pass for 2 weeks. Taking the drug in the second week: you should take the missed tablet as soon as possible, even if this means taking two tablets at once. In the event that during the first week the drug was taken in accordance with the manufacturer's recommendations, then the use of barrier methods of contraception is not required.
3 week pass. Week 3: Increased risk of reduced efficacy as drug break approaches. You should take the missed pill as soon as possible, even if it means taking two pills at the same time. When the pills from the current package run out, you should immediately start taking a new package. In this case, the development of bleeding is unlikely, but spotting spotting may be observed.

In the event that a pass was made to take the drug Janine and bleeding is not observed during the break, then it is necessary to exclude the possibility of pregnancy.

In the event that within 3-5 hours after taking the drug, a woman has vomiting or diarrhea, then it is necessary to use additional contraceptive measures. It is also necessary to adhere to the recommendations regarding the usual skipping of dragees.

If a woman wants to change the start date of the next menstruation, she should take pills from a new package without interruption. Reception can be carried out for as long as it is necessary to delay the next menstruation. Against the background of using the drug from a new package, not intense spotting may be observed.

Side effects

Against the background of the use of Janine dragees, the following undesirable side reactions may develop:

Most often, patients note the development of headache, soreness and coarsening of the mammary glands.

Infrequently, the drug can contribute to the development of vulvovaginitis, candidiasis, increased appetite, decreased mood, the development of dizziness and migraine, increased or decreased blood pressure, abdominal pain, nausea, vomiting, diarrhea, acne and rash, itching, intermenstrual bleeding, swelling of the mammary glands , the development of dysmenorrhea, ovarian cysts, increased fatigue, poor health, weight gain.

In rare cases, the drug can contribute to the development of cystitis, fungal infections, candidiasis, herpetic lesions of the oral cavity, influenza, bronchitis, sinusitis, uterine fibroids, anemia, allergic reactions, anorexia, depression, mental disorders, insomnia, aggression, ischemic stroke, cerebrovascular disorders, dystonia, dryness and irritation of the mucous membranes of the eyes, visual acuity disorders, sudden loss of hearing, tinnitus, cardiovascular disorders, tachycardia, palpitations, thrombosis, thrombophlebitis, hot flashes, varicose veins, pain in the veins, gastritis, enteritis, dyspepsia, allergic and atopic dermatitis, eczema, psoriasis, dandruff, seborrhea, hirsutism, orange peel, myalgia, back and limb pain, cervical dysplasia, menstrual irregularities.

Women who used the drug Jeanine most often reported the development of such complications:

Venous thromboembolic complications.
Arterial thromboembolic complications.
cerebrovascular complications.
arterial hypertension.
Hypertriglyceridemia.
Tumors of the liver.
Deterioration of the course of systemic and chronic diseases.

An increase in the frequency of diagnosing breast cancer has also been reported.

In case of an overdose of the drug, nausea, vomiting, diarrhea, and spotting may develop. A doctor's examination and symptomatic treatment is required.

Additional Information

Against the background of the use of oral contraceptives, changes in laboratory parameters of carbohydrate metabolism, adrenal and thyroid hormones, as well as coagulation parameters can be observed. As a rule, the changes do not go beyond the acceptable limits.

A woman should inform the attending physician who prescribes the use of Jeanine about all concomitant diseases. Hormone replacement therapy should be undertaken only after a careful balance of benefits and harms.

Before prescribing such a drug, the doctor should familiarize himself with the patient's history, identify the presence of hereditary pathologies and conduct a comprehensive examination (measurement of blood pressure and heart rate, determine the body mass index). A gynecological examination includes an examination of the mammary glands, as well as a cytological scraping from the cervix.

The doctor should warn the patient that taking Jeanine is not able to protect against HIV infection and other sexually transmitted diseases.

The effectiveness of the drug is reduced in case of skipping pills, with the development of vomiting, diarrhea, as well as incorrect drug interactions.

Against the background of the use of hormonal contraceptives, the regularity and intensity of bleeding may vary (from spotting to more abundant and prolonged). Evaluation of the effect of the drug on bleeding can be carried out after a period of adaptation of the body to a new drug. The duration of the period can be 2-4 cycles.

If the patient continues to complain of irregular bleeding after 2-4 cycles, then a comprehensive examination is required to exclude malignant neoplasms or pregnancy.

The risk of developing thromboembolism increases during the first year of using the drug. In patients who take low-dose oral contraceptives, the risk of developing thromboembolism is several times higher than in women who do not take such drugs.

In women with a history of a hereditary form of angioedema, the symptoms of the disease may be aggravated by the use of Zhanin.

The ability of the drug to influence psychomotor reactions and vehicle control has not been identified.

drug interaction

In the case of simultaneous administration, the use of oral combined contraceptives can increase the concentration of cyclosporine and reduce the concentration of lamotrigine in plasma and tissues.

Simultaneous use of antifungal drugs, verapamil, macrolides, antidepressants and grapefruit juice can increase the concentration of dienogest in blood plasma.

If it is necessary to combine Zhanin with antibacterial drugs (excluding rifampicin and griseofulvin), barrier methods of contraception should be used for 1 week after antibiotics have been discontinued.

Analogues and cost

The cost of the drug Jeanine for the period of autumn 2016 was formed as follows:

Jeanine dragee No. 21 - 900-1200 rubles.
Jeanine dragee No. 63 - 2050-3400 rubles.

Analogues of the drug Jeanine are such drugs: Diecyclen and Siluet. If necessary, the replacement of the drug should be carried out only in agreement with the attending physician.

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