Ethinylestradiol, Dienogest | Jeanine Dragee, 63 pcs.

Latin name

EUCABAL

Release form

dragee



packaging 63 pcs

Indications

Hormonal contraception.

Use during pregnancy and lactation

JanineВ® is not prescribed during pregnancy and during lactation.

If pregnancy is detected while taking JanineВ®, it should be stopped right away. However, extensive epidemiological studies did not reveal any increased risk of developmental defects in children born to women who received sex hormones before pregnancy, or teratogenicity when sex hormones were taken by negligence in the early stages of pregnancy.

Taking combined oral contraceptives can reduce the amount of breast milk and change its composition, so their use is contraindicated in lactation. A small amount of sex steroids and / or their metabolites may be excreted in milk.

Composition of

1 tablet contains: active substance: ethinyl estradiol 0.03 mg, dienogest 2 mg,

excipients: lactose monohydrate starch potato gelatin talcum magnesium stearate sucrose dextrose (glucose syrup zy) Macrogol 35000 povidone K25 calcium carbonate, titanium dioxide (E171), carnauba wax

Dosage and administration

Inside, with a small amount of water, daily at about the same time of day, in the order indicated on the package. Take 1 tablet per day, continuously for 21 days. Reception of the next package begins after a 7-day break in taking dragees, during which withdrawal bleeding usually occurs. Bleeding, as a rule, begins on the 2nd – 3rd day after taking the last dragee and may not end until the start of taking a new package.

Taking Jeanine® begins:

- in the absence of taking any hormonal contraceptives in the previous month. Reception of Zhanina® begins on the first day of the menstrual cycle (i.e. on the first day of menstrual bleeding). It is allowed to start taking on the 2nd – 5th day of the menstrual cycle, but in this case, it is recommended to additionally use the barrier method of contraception during the first 7 days of taking dragees from the first

package - when switching from other combined oral contraceptives (from the vaginal ring, transdermal patch). It is preferable to start taking Janine® the day after taking the last active dragee from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 dragees), or after taking the last inactive dragee (for drugs containing 28 tablets in a package). When switching from a vaginal ring, transdermal patch, it is preferable to start taking Janine® on the day the ring or patch is removed, but no later than the day, when a new ring is to be inserted or a new

patch is pasted - when switching from contraceptives containing only gestagens ("mini-dranks", injection forms, implants), or an intrauterine contraceptive-releasing gestagen (Mirena). A woman can switch from “mini-drinking” to Janine® any day (without a break), from an implant or an intrauterine contraceptive with gestagen - on the day of its removal, from the injection form - from the day the next injection should have been made. In all cases, it is necessary to use the additional barrier method of contraception during the first 7 days of taking the

dragee - after an abortion in the first trimester of pregnancy. A woman can start taking the drug immediately. Subject to this condition, a 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 in the second trimester of pregnancy. 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 dragee. If a woman has already lived sexually, pregnancy should be ruled out before the start of taking Janine® or it is necessary to wait for the first menstruation.

Reception of the missed jelly beans. If the delay in taking the drug was less than 12 hours, contraceptive protection does not decrease. A woman should take the dragee as soon as possible, the following is taken at the usual time.

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

- the drug should never be interrupted for more than 7 days

- to achieve adequate suppression of the hypothalamic-pituitary-ovarian regulation, 7 days of continuous use of dragees are required.

If the delay in taking the dragee was more than 12 hours (the interval since the last dragee was taken was more than 36 hours), the following tips can be given.

First week of taking

A woman should take her last missed dragee as soon as possible (even if it means taking two dragees at the same time). The following dragees are taken at normal times. Additionally, a barrier method of contraception (such as a condom) should be used over the next 7 days. If sexual intercourse took place during the week before skipping a dragee, it is necessary to consider the likelihood of pregnancy. The more dragees missed and the closer the interval in taking active substances, the greater the likelihood of pregnancy.

Second week of taking

A woman should take her last missed tablet as soon as possible (even if it means taking two tablets at the same time). The following dragees are taken at normal times.

Provided that the woman took the dragee correctly within 7 days preceding the first missed dragee, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more tablets, it is necessary to additionally use barrier methods of contraception (such as a condom) for 7 days.

Third week of taking

The risk of a decrease in reliability is inevitable due to the upcoming break in the dragee.

A woman should strictly adhere to one of the following two options (if in the 7 days preceding the first missed dragee, all dragees were taken correctly, there is no need to use additional contraceptive methods):

1. A woman should take the last missed dragee as soon as possible (even if it means taking two tablets at the same time). The next dragee is taken at the usual time until the dragee from the current package runs out. The next packaging should be started immediately. Cancellation bleeding is unlikely until the second pack is over, but spotting and breakthrough bleeding may occur while taking the dragee.

2. A woman can also stop taking dragees from the current package. Then she must take a break for 7 days, including the day of the pass of the dragee, and then start accepting new packaging.

If a woman missed taking a dragee and then during a break in taking a dragee, she did not have withdrawal bleeding, pregnancy should be excluded.

Recommendations for vomiting and diarrhea

If a woman has vomited or diarrhea within 4 hours after taking active dragees, absorption may not be complete and additional contraceptive measures should be taken. In these cases, you should be guided by the recommendations when skipping the reception of dragees.

Change the day of the beginning of the menstrual cycle

In order to delay the onset of menstruation, a woman should continue taking dragees from the new Janine® packaging immediately after all dragees from the previous one were taken, without interruption in reception. Dragees from this new package can be taken as long as the woman wants (until the package is finished). Against the background of taking the drug from the second package, a woman may have spotting or breakthrough uterine bleeding. To resume taking Janine® from a new pack should be after the usual 7-day break.

In order to transfer the day the menstruation begins to another day of the week, a woman should be advised to shorten the next break in taking dragees for as many days as she wants. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and there will subsequently be spotting and breakthrough bleeding during the second pack (as well as in the case when she would like to delay the onset of menstruation).

Additional information for special patient categories

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

Elderly patients. Not applicable. Zhanin® is not indicated after menopause.

Patients with hepatic impairment. The drug Janine® is contraindicated in women with severe liver diseases until liver function indicators return to normal (see also the section "Contraindications").

Patients with impaired renal function. The drug Janine® has not been specifically studied in patients with impaired renal function. Available data do not suggest treatment changes in such patients.

Side effects

From the digestive system: nausea, vomiting.

From the reproductive system: changes in vaginal secretion.

From the endocrine system: engorgement, tenderness of the mammary glands, secretion of the secretion of changes in body weight, changes in libido from them.

From the side of the central nervous system: decreased mood, headache, migraine.

Other: chloasma, poor tolerance of contact lenses, fluid retention in the body, allergic reactions.

Drug Interaction

Interaction with oral contraceptives with other drugs may lead to breakthrough bleeding and / or decreased contraceptive reliability. The following types of interaction have been reported in the literature.

Impact on hepatic metabolism: The use of drugs that induce microsomal enzymes of the liver can lead to an increase in the clearance of sex hormones. These drugs include: phenytoin, barbiturates, primidone, carbamazepine, rifampicin. There are also assumptions regarding oxcarbazepine, topiramate, felbamate, griseofulvin and preparations containing St. John's wort.

HIV proteases (eg ritonavir) and non-nucleoside reverse transcriptase inhibitors (eg nevirapine) and their combinations can also potentially affect hepatic metabolism.

Effect on the intestinal circulation: According to some studies, some antibiotics (such as penicillins and tetracycline) can reduce the intestinal circulation of estrogens, thereby reducing the concentration of ethinyl estradiol.

During the appointment of any of the above drugs, a woman should additionally use a barrier method of contraception (such as a condom).

Substances that affect the metabolism of combined hormonal contraceptives (enzyme inhibitors). Dienogest is a substrate for cytochrome P450 (CYP) 3A4. Known CYP3A4 inhibitors such as azole antifungal drugs (eg ketoconazole), cimetidine, verapamil, macrolides (such as erythromycin), diltiazem, antidepressants and grapefruit juice may increase plasma levels of dienogest.

When using drugs that affect microsomal enzymes, and within 28 days after their withdrawal, the barrier method of contraception should be used.

During the administration of antibiotics (except rifampicin and griseofulvin) and within 7 days after their withdrawal, the barrier method of contraception should be used. If the period of use of the barrier method of protection ends later than the tablets in the package, it is necessary to move to the next package without the usual interruption in the reception of the dragee.

Oral combination contraceptives may affect the metabolism of other medicines, which leads to an increase (eg cyclosporine) or a decrease (eg lamotrigine) in their plasma and tissue concentrations.

Overdose

Symptoms: nausea, vomiting, slight vaginal bleeding (in girls).

Treatment: carry out symptomatic therapy. There is no specific antidote.

Storage conditions

The drug should be stored at a temperature not exceeding 25 РC.

Expiration

3 years.

Deystvuyuschee substances

ethinyl estradiol, Dienogest

dosage form

dosage form

dragees

Bayer Pharma AG, Germany