Visanne, pills 2mg, 84pcs

Composition

One tablet contains:

dienogest 2 mg.

Auxiliary substances:

lactose monohydrate,

potato starch,

microcrystalline cellulose,

povidone K 25,

talc,

crospovidone,

magnesium stearate.

Pharmacological action

Visanne is a derivative of nortestosterone, which has no androgenic activity, but has a significant antiandrogenic effect, which is approximately one-third of the activity of ciproterone acetate.

Dienogest binds to progesterone receptors in the human uterus, while having only 10% of the relative affinity of progesterone. Despite its low affinity for progesterone receptors, dienogest is characterized by a powerful progestogenic effect in vivo.

Dienogest has no significant androgenic, mineralocorticoid, or glucocorticoid activity in vivo.

Dienogest affects endometriosis by reducing the endogenous production of estradiol and thereby suppressing its trophic effects on both the eutopic and ectopic endometrium. With continuous use, dienogest creates a hypoestrogenic, hypergestagenic endocrine environment, causing initial decidualization of endometrial tissue with subsequent atrophy of endometrioid foci.

Additional properties of dienogest, such as immunological and anti-angiogenic effects, obviously contribute to its suppressive effect on cell proliferation.

Indications

Treatment of endometriosis.

Contraindications

Visanne should not be used in the presence of any of the following conditions, which are partially taken from information on other drugs containing only the progestogen component. If any of these conditions develop while taking Visanne, the use of the drug should be stopped immediately.

– active venous thromboembolic conditions; – heart and vascular diseases (for example, myocardial infarction, stroke, ischemic heart disease) at the present time or in the past; – diabetes mellitus with vascular complications;- severe liver diseases at present or in the past, until the indicators of liver function return to normal; – liver tumors (benign and malignant) at present or in the past;- identified or suspected malignant tumors dependent on sex steroids; – vaginal bleeding of unknown origin; – hypersensitivity to the Active ingredient or to any of the excipients.

Side effects

Side effects are more likely to occur in the first months of taking Visanne and their frequency decreases during treatment with the drug. The following side effects were observed in women taking Visanne.

The most common side effects during treatment with Visanne, which were at least considered to be possibly related to taking the drug, include: headache (9.0%), breast discomfort (5.4%), decreased mood (5.1%) and acne (5.1%).

The following are adverse drug reactions classified by organ system class according to MedDRA-the Medical Dictionary for Regulatory Activities.

Side effects in each frequency group are presented in descending order of frequency. Frequency indicators are based on combined data from four clinical trials involving 332 patients (100%). Often (≥1/100 Inechasto (≥1/1000 before

Interaction

Individual inducers or inhibitors of enzymes (CYP3A isoenzyme):

Progestins, including dienogest, are mainly metabolized with the participation of the cytochrome P450 3A4 (CYP3A4) system, localized both in the intestinal mucosa and in the liver. Therefore, inducers or inhibitors of CYP3A4 may affect the metabolism of progestogenic drugs. Increased clearance of sex hormones due to the induction of enzymes can lead to a decrease in the therapeutic effect of Visanne, as well as cause side effects, for example, a change in the nature of uterine bleeding.

Decreased sex hormone clearance due to enzyme inhibition may increase dienogest exposure, which may lead to side effects.

Substances capable of inducing enzymes:

The use of drugs that induce microsomal liver enzymes (for example, cytochrome P450 enzymes) can lead to an increase in the clearance of sex hormones. These drugs include: phenytoin, barbiturates, primidone, carbamazepine and rifampicin; there are also suggestions for oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin, nevirapine and preparations containing St. John’s wort. The maximum induction of enzymes, as a rule, is noted not earlier than in 2-3 weeks, but then it can persist for at least 4 weeks after discontinuation of therapy.

Substances that can inhibit enzymes:

Known CYP3A4 inhibitors, such as azole antifungal drugs (for example, ketoconazole, itraconazole, fluconazole), cimetidine, verapamil, macrolides (for example, erythromycin, clarithromycin and roxithromycin), diltiazem, protease inhibitors (for example, ritonavir, saquinavir, indinavir, nelfinavir), antidepressants (for example, nefazodone, fluvoxamine, fluoxetine) and grapefruit juice, may increase the concentration of progestogens in blood plasma and lead to the development of side effects.

Effect of dienogest on other medicinal substances:

Based on data from in vitro inhibition studies, it is unlikely that a clinically significant interaction of Visanne with the metabolism of other drugs involving cytochrome P450 enzymes will occur. Interaction with food products:

A standardized high-fat meal had no effect on the bioavailability of Visanne.

Other types of interaction:

The use of progestogens may affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma protein concentrations, such as lipid/lipoprotein fractions, carbohydrate metabolism parameters, and clotting parameters. Changes usually do not exceed the limits of normal values.

How to take, course of use and dosage

For oral use. You can start taking pills on any day of your menstrual cycle. Take one tablet a day without a break, preferably at the same time every day, if necessary, with a liquid. Tablets should be taken continuously, regardless of vaginal bleeding.

After completing one package, start taking the next one without a break in taking tablets. The effectiveness of Visanne may be reduced by skipping pills, vomiting and / or diarrhea (if this occurs within 3-4 hours after taking the pill).

If you miss one or more pills, the woman should take only one pill as soon as she remembers, and then continue taking the pills at the usual time the next day. A tablet that is not absorbed due to vomiting or diarrhea should be replaced with an additional tablet.

There is no corresponding indication for the use of Visanne in elderly patients. There are no data indicating the need for dose adjustment in patients with renal insufficiency.

Special instructions

Before taking Visanne, it is necessary to exclude pregnancy. While taking Visanne, if contraception is necessary, patients are recommended to use non-hormonal contraceptive methods (for example, the barrier method).

If a pregnancy occurs in women who use contraceptives with only a progestogen component (for example, minipil), it is more likely to be ectopic, compared to pregnancy that occurs while taking combined oral contraceptives. Therefore, the question of using Visanne in women with a history of ectopic pregnancy or with impaired fallopian tube function should be decided only after a thorough assessment of the benefits and risks.

Since Visanne is a drug with only a progestogenic component, it can be assumed that special warnings and precautions for the use of other drugs with a progestogenic component are also applicable for the use of Visanne, although not all warnings and precautions are based on relevant results in the course of clinical studies of Visanne.

If any of the following conditions or risk factors are present or worsen, an individual risk/benefit assessment should be performed before starting or continuing to take Visanne.

Form of production

Tablets

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

5 years

Active ingredient

Dienogest

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For women, For adults as prescribed by a doctor

Indications

Endometriosis