Jeanine coated tablets №21

Description

Jeanine Storage
active substances: ethinylestradiol, dienogest;

1 film-coated tablet contains 0.03 mg of ethinyl estradiol and 2 mg of dienogest;

Excipients: lactose monohydrate, corn starch, maltodextrin, magnesium stearate, sucrose, glucose syrup, calcium carbonate, povidone K25, macrogol 35000, carnauba wax, titanium dioxide (E 171).

Jeanine Dosage form
Coated tablets.

Main physical and chemical properties: shiny, coated tablets, white.

Jeanine Pharmacotherapeutic group
Hormonal contraceptives for systemic use. Progestogens and estrogens, fixed combinations. Dienogest and ethinyl estradiol.

ATX code G03A A16.

Jeanine Pharmacological properties

Pharmacodynamics

All hormonal methods of contraception are characterized by a very low rate of contraceptive failure when used according to instructions. Contraceptive failure rates may be higher if contraceptives are not used as directed (eg, skipping a pill).

In the course of clinical trials conducted with the drug Janine®, the Pearl Index was calculated:

unadjusted Pearl index: 0.454 (upper 95% confidence interval (CI): 0.701);
adjusted Pearl index: 0.182 (upper 95% confidence interval: 0.358).
Janine® is a combined oral contraceptive (COC) with ethinyl estradiol and the progestogen dienogest.

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

Dienogest is a derivative of nortestosterone with an in vitro affinity for progesterone receptors, 10-30 times less than other synthetic progestogens. In vivo data in animals indicate strong progestogenic and antiandrogenic activity. Dienogest does not show significant androgenic, mineralocorticoid or glucocorticoid activity in vivo.

The dose of dienogest, which leads to suppression of ovulation, is 1 mg / day.

High-dose COCs (50 mcg ethinyl estradiol) reduce the risk of endometrial and ovarian cancer. Whether this applies to low-dose COCs remains unclear.

Indication
Oral contraception.

Contraindication
Combined hormonal contraceptives (COCs) should not be used in the presence of at least one of the conditions listed below. If any of these conditions occur for the first time during the use of KGC, its use should be stopped immediately.

Presence or risk of venous thromboembolism (VTE)
o Presence of venous thromboembolism today (during anticoagulant therapy) or in the anamnesis (eg deep vein thrombosis (DVT), pulmonary embolism (pulmonary embolism));

o known hereditary or acquired predisposition to venous thromboembolism, such as resistance to activated protein C (including Leiden factor V mutation), antithrombin III deficiency, protein C deficiency, protein S deficiency;

o major surgery with prolonged immobilization (see section “Features”);

o high risk of venous thromboembolism due to the presence of multiple risk factors (see section “Peculiarities”).

Presence or risk of arterial thromboembolism (ATE)
o arterial thromboembolism – the presence of arterial thromboembolism now or in the anamnesis (eg, myocardial infarction) or the presence of prodromal symptoms (eg, angina);

o cerebral circulatory disorders now or in the anamnesis, the presence of prodromal symptoms (eg, transient ischemic attack (TIA));

o known hereditary or acquired predisposition to arterial thromboembolism, such as hyperhomocysteinemia and antibodies to phospholipids (antibodies to cardiolipins, lupus anticoagulant);

o migraine with focal neurological symptoms in the anamnesis;

o high risk of arterial thromboembolism due to the presence of multiple risk factors (see section “Peculiarities”) or due to the presence of one serious risk factor, such as:

diabetes mellitus with vascular complications;
severe hypertension;
severe dyslipoproteinemia.
Current or history of pancreatitis if associated with severe hypertriglyceridemia.
Severe liver disease is now or in the anamnesis until liver function tests return to normal.
Presence now or in the anamnesis of liver tumors (benign or malignant).
Known or suspected malignancies (such as genitals or mammary glands) that are dependent on sex hormones.
Established or suspected pregnancy.
Vaginal bleeding of unknown etiology.
Hypersensitivity to the active substances or to any of the components of the drug.
Zhanin® is contraindicated when co-administered with medicinal products containing ombitasvir / paritaprevir / ritonavir and dasabuvir (see sections “Special warnings and special precautions for use” and “Interaction with other medicinal products and other forms of interaction”).