JEANINE

Dosage form, composition and packaging

Tablets, white, smooth.

Jeanine - Contraceptive Pharmacological action

Low-dose monophasic oral combined estrogen-progestin contraceptive product.

Jeanine contraceptive effect is achieved by complementary mechanisms, the most important of which are suppression of ovulation and changes in the viscosity of cervical mucus, causing it to become impervious to sperm.

When properly implemented, the Pearl Index (an indicator of the number of pregnancies in 100 women taking a contraceptive during one year) is less than 1. If pills are being missed or used incorrectly, the Pearl Index may increase.

Progestin component of Jeanine - dienogest - has antiandrogenic action, which is confirmed by the results of several clinical studies. Furthermore, dienogest improves blood lipid profile (increases the amount of high density lipoproteids).

In women receiving combined oral contraceptives menstrual cycle becomes more regular, painful menstruations are observed more rarely, the intensity and duration of the bleeding is decreased, thus reducing the risk of iron deficiency anemia. In addition, there is evidence of reduced risks of endometrial cancer and ovarian cancer.

Jeanine - Contraceptive Dosage

Tablets should be taken orally in the order indicated on the package every day at about the same time, with a little water. One should take 1 tablet a day continuously for 21 days. The next pack should be started after the 7-day break, during which withdrawal bleeding occurs (menstruation-like bleeding). It usually begins on the 2nd-3rd day after the last tablet was taken and may not end before you start taking the tablets from a new pack.

Starting Jeanine - Contraceptive

If no hormonal contraceptives were used in the previous month one should start taking Janine on the 1st day of the menstrual cycle (i.e. the 1st day of menstrual bleeding). One can also start taking it on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to use a barrier method of contraception during the first 7 days of taking pills from the first pack.

When changing from a combined oral contraceptive, vaginal ring, transdermal patch, one should start taking Jeanine on the next day after taking the last active pill from the previous pack, but, in any case, not later than the day after the usual 7-day break in the reception (for products containing 21 pills), or after the last inactive pill (for products containing 28 pills per pack). In case of transition from the vaginal ring or the transdermal patch it is preferable to start taking Jeanine on the day of removal of the ring or the patch, but not later than the day when a new ring or a new patch should be implemented.

In case of transition from contraceptives containing only progestin (the "mini-pill", injectable forms, implant) or progestogen-releasing intrauterine device (Mirena) a woman can switch from the “mini-pills" to Jeanine on any day (without interruption), from the implant or IUD with progestogen - on the day of its removal, from the injectable contraceptive - on the day when the following dose should be injected. In all cases, one must use an additional barrier method of birth control during the first 7 days of taking pills.

After an abortion in the I trimester of pregnancy a woman may start taking the drug immediately. In this case, the woman does not need any additional birth control methods.

After childbirth or abortion in the II trimester of pregnancy it is recommended to start taking the drug on the 21st-28th days after the childbirth or abortion in the II trimester of pregnancy. If pills are started later, one must use an additional barrier method of birth control during the first 7 days of taking pills. However, if a woman has already been sexually active, before starting Jeanine one must rule out pregnancy or wait for the first menstruation.

Taking missed pills

If the delay in taking pills is less than 12 hours, contraceptive effect is not reduced. A woman should take the missed pill as soon as possible, and the following pill should be taken at the usual time.

If the delay in taking pills is than 12 hours, contraceptive effect may be reduced.

In this case, one can be guided by the following two basic rules:

• the drug administration should never be interrupted for more than 7 days;
• in order to achieve adequate suppression of the hypothalamic-pituitary-ovarian system it is required to take the pills for 7 days continuously.

Correspondingly, if the delay in taking the active pills was more than 12 hours (interval from the moment of taking of the last active pill is more than 36 hours), we can recommend the following:

The first week of taking the Jeanine - Contraceptive

One must take the last missed pill as soon as possible, as soon as the woman remembers it (even if she needs to take two pills at the same time because of that). The next pills should be taken at the usual time. Additionally, a barrier method of birth control (such as a condom) should be used for the next 7 days. If an intercourse took place during the week before missing pills, one must take into account the probability of pregnancy. The more pills are missed, and the closer they are to the break in the administration of active substances, the greater is the likelihood of pregnancy.

The second week of taking the Jeanine - Contraceptive

One must take the last missed pill as soon as possible, as soon as the woman remembers it (even if she needs to take two pills at the same time because of that). The next pills should be taken at the usual time. On condition that the woman was taking the pills correctly for 7 days prior to the first missed pill, there is no need for additional contraceptive measures. Otherwise, as well as in case of missing two or more pills it is necessary to use additional barrier birth control methods (such as condoms) for 7 days.

The third week of taking the Jeanine - Contraceptive

The risk of pregnancy increases because of the upcoming break in taking pills. A woman should strictly adhere to one of the following options. In this case, if during 7 days before the first missed pill all the pills were taken correctly, there is no need to use additional birth control methods.

1. One must take the last missed pill as soon as possible, as soon as the woman remembers it (even if she needs to take two pills at the same time because of that). The next pills should be taken at the usual time until the pills from the current pack run out. The next pack should be started immediately without a break. Withdrawal bleeding is unlikely until the end of the second pack, but one may experience spotting and breakthrough bleeding while taking pills.

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

If a woman missed a pill, and then during a break in the drug administration she had no withdrawal bleeding, pregnancy must be ruled out.

Recommendations in case of vomiting and diarrhea

If the woman was vomiting or had diarrhea within 4 hours after taking an active pill, absorption may not be complete and additional contraceptive measures should be taken. In these cases, one should be guided by the recommendations for missing pills.

Changing the date of the beginning of the menstrual cycle

In order to delay the onset of menstruation, the woman should continue taking pills from a new Jeanine pack immediately after taking all the pills from the previous one, without a break in administration. The pills from this new pack may be taken for as long as she wants (until all the pills from the pack run out). While taking the pills from the second pack, a woman may experience spotting or breakthrough uterine bleeding. One should resume administration of Jeanine from the new pack after the usual 7-day break.

To change the first day of menstruation to another day of the week, a woman should shorten the nearest break in taking pills by as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding, and that the spotting and breakthrough bleeding will continue during taking the pills from the second pack (just like when she wanted to delay the onset of menstruation).

Additional information for special categories of patients

Children and adolescents can use Jeanine only after menarche.

Jeanine should not be used after menopause.

The Jeanine - Contraceptive is contraindicated for women with severe liver diseases until liver function tests are normalized.

Jeanine has not been specifically studied in patients with impaired renal function. Available data do not suggest changing the treatment of such patients.

Jeanine - Contraceptive Overdose

Serious disturbances in case of overdose have not been reported.

Symptoms: nausea, vomiting, spotting or metrorrhagia.

Treatment: symptomatic therapy. There is no specific antidote.

Jeanine - Contraceptive interactions

The interaction of oral contraceptives with other drugs may lead to breakthrough bleeding and/or reduce the contraceptive reliability.

The following types of interaction have been reported in literature.

Effect on hepatic metabolism

The use of drugs that induce hepatic microsomal enzymes may lead to increased clearance of the sex hormones. These drugs include phenytoin, barbiturates, primidone, carbamazepine, rifampicin; also there are suggestions in relation to oxcarbazepine, topiramate, felbamate, griseofulvin and products containing St. John's wort.

HIV-protease inhibitors (such as ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and their combinations may also potentially affect the liver metabolism.

Effect on the enterohepatic circulation

According to some studies, certain antibiotics (e.g., penicillins and tetracycline) may reduce the enterohepatic circulation of estrogen, thereby decreasing the concentration of ethinyl estradiol.

During the administration of any of the abovementioned drugs a woman should use an additional barrier birth control method (such as a condom).

Substances that affect the metabolism of combined hormonal contraceptives (enzyme inhibitors)

Dienogest is a substrate of cytochrome P450 (CYP)34. Known CYP3A4 inhibitors such as azole antifungals (e.g., ketoconazole), cimetidine, verapamil, macrolides (e.g. erythromycin), diltiazem, antidepressants and grapefruit juice, may increase plasma levels of dienogest.

During administration of drugs affecting microsomal enzymes, and 28 days after their discontinuation one should use an additional barrier birth control method.

During administration of antibiotics (except rifampicin and griseofulvin) and for 7 days after their discontinuation one should use an additional barrier birth control method. If the period of use of a barrier birth control method ends later than pills in a pack, one should move to the next Jeanine package without the usual break in taking pills.

Combination oral contraceptives may affect the metabolism of other drugs, which leads to an increase (e.g., cyclosporine) or decrease (e.g., lamotrigine) in their concentrations in plasma and tissues.

Jeanine - Contraceptive Pregnancy and lactation

Jeanine is not used during pregnancy and breastfeeding.

If pregnancy is detected during administration of Jeanine, the drug should be immediately discontinued. However, extensive epidemiological studies have revealed no increased risk of developmental defects in children born to women treated with hormones before pregnancy, or teratogenic effect when hormones were taken inadvertently in early pregnancy.

Administration of combined oral contraceptives may decrease the amount of breast milk and change its composition, so their use is contraindicated during lactation. A small amount of sex hormons and/or their metabolites may be excreted in milk.

Jeanine - Contraceptive Side effects

During administration of combined oral contraceptives one may experience irregular bleeding (spotting or breakthrough bleeding), especially during the first months of use. During administration of Jeanine other adverse effects, listed in the table below, were observed in women. Within each group, selected depending on the frequency of adverse effects, adverse effects are shown in order of decreasing of severity.

In women receiving combined oral contraceptives  the development of the following adverse effects has been reported: venous thromboembolism complications, arterial thromboembolic complications, cerebrovascular complications, arterial hypertension, hypertriglyceridemia, changes in glucose tolerance or effect on insulin resistance of peripheral tissues, liver tumors (benign or malignant), compromised liver function, chloasma.

In women with hereditary angioedema exogenous estrogens may exacerbate symptoms.

The emergence or worsening of conditions for which the relationship with the use of combined oral contraceptives has not been proven unequivocally: jaundice and/or itching associated with cholestasis, gallstones formation, porphyria, systemic lupus erythematosus; hemolytic uremic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis with hearing impairment, Crohn's disease, ulcerative colitis, cervical cancer.

In women using combined oral contraceptives, a very slight increase in the detection rate of breast cancer is observed. Because breast cancer rarely occurs in women below 40 years of age, given the total risk of breast cancer, an additional number of cases is very small. The relation to the use of combined oral contraceptives is not known.

Jeanine - Contraceptive Storage time and conditions

The drug should be stored out of children’s reach at a temperature not exceeding 25°C. Shelf life - 3 years.

Jeanine - Contraceptive Indications

- contraception (birth control).

Jeanine - Contraceptive Contraindications

Jeanine should not be used in the presence of any of the conditions/diseases listed below. If any of these conditions develop for the first time during the administration of the drug, the drug should be immediately discontinued.

• the presence of thromboses (venous and arterial) at present or in history (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular disturbances);
• the presence of condition preceding thrombosis at present or in history (e.g., transient ischemic attacks, angina pectoris);
• diabetes with vascular complications;
• the presence of migraine with focal neurological symptoms at present or in history;
• the presence of severe or multiple risk factors for venous or arterial thrombosis (including complicated  valvular lesions, atrial fibrillation, cerebrovascular diseases or diseases of coronary arteries of the heart, uncontrolled arterial hypertension, major surgery with prolonged immobilization, smoking at the age of over 35 years);
• liver failure and severe liver diseases (until normalization of liver function tests);
• the presence of pancreatitis with severe hypertriglyceridemia at present or in history;
• the presence of benign or malignant liver tumors at present or in history;
• identified hormone-dependent malignant diseases of genitals or breasts or suspicion thereof;
• vaginal bleeding of unknown origin;
• pregnancy or suspicion of it;
• period of breast-feeding;
• hypersensitivity to the drug components.

With caution

One should carefully weigh the potential risks and expected benefits of the use of combined oral contraceptives in each individual case in the presence of the following diseases/conditions and risk factors:

• risk factors for thrombosis and thromboembolism (smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, valvular diseases, prolonged immobilization, major surgery, major trauma, genetic predisposition to thrombosis/thromboses, myocardial infarction or cerebrovascular disturbance at a young age in someone from the next of kin);
• other diseases, which may cause peripheral circulatory disorders (diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, Crohn's disease, ulcerative colitis, sickle cell anemia, phlebitis of superficial veins);
• hereditary angioedema;
• hypertriglyceridemia;
• liver diseases;
• diseases first caused or aggravated by pregnancy or previous use of sex hormones (e.g., jaundice, cholestasis, gallbladder diseases, otosclerosis with hearing impairment, porphyria, herpes gestationis, Sydenham's chorea);
• postpartum period.

In case of renal impairment

Administration of Jeanine can influence biochemical parameters of renal function.

In case of abnormal liver function

If any liver dysfunctions occur, a temporary discontinuation of Jeanine may be required until the normalization of laboratory parameters. In case of development of cholestatic jaundice or cholestatic pruritus (which first appeared during pregnancy or previous use of sex hormones) Jeanine should be discontinued