Visanne pills 2 mg №28

Pills

Composition

One pill contains: Dienogest 2 mg.
Excipients: lactose monohydrate, potato starch, microcrystalline cellulose, Povidone K25, talc, crospovidone, Magnesium stearate.

Packing

In the package of 28 tablets.

Mechanism of action

Visanne (Dienogest) is a derivative of Nortestosterone, which does not have androgenic activity, but has a largely anti-androgenic effect, which is about one third of cyproterone acetate activity.
Dienogest binds to Progesterone receptors in the human uterus, with only 10% of the relative affinity of progesterone. Despite its low affinity for progesterone receptors, dienogest has a powerful progestogenic effect in vivo.
Dienogest does not have significant androgenic, mineralocorticoid or glucocorticoid activity in vivo.
Dienogest affects endometriosis, reducing endogenous production of estradiol and thereby, suppressing its trophic effects on both eutopic and ectopic endometrium. With continuous use, dienogest creates a hypoestrogenic, hyperhestagenic endocrine environment, causing an initial decidualization of the endometrial tissue with subsequent atrophy of the endometrial foci.
Additional properties of dienogest, such as immunological and anti-angiogenic effects, obviously, contribute to its overwhelming effect on cell proliferation.

Indications and usage

Treatment of endometriosis.

Contraindications

Visanna should not be used in the presence of any of the following conditions, which are partially taken from information on other drugs that contain only the progestogen component. If any of these conditions develops on the background of the reception of Visanne, the use of the drug should be stopped immediately.
- active venous thromboembolic states;
- diseases of the heart and blood vessels (for example, myocardial infarction, stroke, coronary heart disease) now or in the past;
- diabetes with vascular complications;
- severe liver disease in the present or in the past, as long as indicators of hepatic function do not return to normal;
- liver tumors (benign and malignant) now or in the past;
- identified or suspected malignant tumors, dependent on sex steroids;
- vaginal bleeding of unknown origin;
- hypersensitivity to the active substance or to any of the excipients.

For oral administration. The pill can be started on any day of the menstrual cycle. Take one pill per day without a break, preferably at the same time every day, if necessary, with a liquid.Tablets must be taken continuously, regardless of vaginal bleeding. After completing one pack, start taking the next one without interruption in taking the pills. The effectiveness of Visanne may decrease when skipping pills, vomiting and / or diarrhea (if it occurs within 3-4 hours after taking the pill). If one or several pills are missed, a 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 pill that is not absorbed due to vomiting or diarrhea should be replaced by an additional dose of one pill.

There is no appropriate indication for the use of Visanne in elderly patients.

There is no data indicating the need for dose adjustment in patients with renal insufficiency.

Adverse reactions

Side effects often occur in the first months of taking Visanne and their frequency decreases in the course of drug treatment.

The following side effects were noted in women while receiving the Visanne.
The most frequent side effects in the process of treatment of Visanne, which, at least, were considered as possibly related to taking the drug, include: headache (9.0%), discomfort in the mammary glands (5.4%), decrease in mood ( 5.1%) and acne (5.1%).
The following are undesirable drug reactions divided into organ system classes according to MedDRA - Medical Dictionary for Regulatory Activities.
Side effects in each frequency group are presented in decreasing order of frequency.Frequency rates are based on pooled data from four clinical trials involving 332 patients (100%).
Often (≥1 / 100 and <1/10): weight gain, decrease in mood, mood changes, sleep disturbances, nervousness, loss of libido, headache, migraine, nausea, abdominal pain, flatulence, bloating, vomiting, acne, alopecia, back pain, discomfort in the mammary glands, ovarian cyst, hot flashes, uterine * / vaginal bleeding, including spotting, asthenic conditions, irritability
Infrequently (≥1 / 1000 to <1/100): anemia, weight loss, increased appetite, anxiety, depression, mood swings, peripheral nervous system imbalances, impaired attention, dry eyes, tinnitus, non-specific circulatory disorders, palpitations, arterial hypotension, dyspnea, gingivitis, abdominal discomfort, diarrhea, constipation, inflammatory diseases of the gastrointestinal tract, dry skin, hyperhidrosis, itching, hirsutism, onychoclasia, dandruff, dermatitis, hair growth disorder, reaction to sensitivity, impaired pigmentation, pain in the bones, muscle cramps, pain in the limbs, feeling of heaviness in the limbs, urinary tract infection, vaginal candidiasis, dryness in the vulvovaginal region, discharge from the genital tract, pain in the pelvic region, atrophic vulvovaginitis, areas of lactation in the milky gland, fibrocystic mastopathy, general breast lump, edema.

Special notes

Before starting the reception of Visanne, pregnancy should be excluded (seesection "Pregnancy and lactation" "). During the reception of the Visanne, if necessary, contraception patients are recommended to use non-hormonal contraceptive methods (for example, the barrier method).
In pregnancy, it has arisen in women who use contraceptive drugs with only the gestagen component (for example, minipily) is more likely to have its ectopic localization, compared with pregnancy that occurred while taking combined oral contraceptives. Therefore, the question of the application of Visanne in women with an ectopic pregnancy in history or with impaired function of the fallopian tubes should be resolved only after a thorough assessment of the balance of benefits and risks.
Since Visanne is a drug with only a gestagen component, it can be assumed that special precautions and precautions for the use of other drugs with a gestagen component are also applicable for Visanne, although not all precautions and precautions are based on the relevant results of the Visanne clinical studies..
If any of the conditions or risk factors listed below are present or aggravated, an individual assessment of the risk / benefit ratio should be carried out before starting or continuing to take Visanna.

Drug Interactions

Individual inducers or inhibitors of enzymes (CYP3A isoenzyme):
Progestins, including dienogest, are metabolized predominantly 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 can affect the metabolism of progestin 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.
Reducing the clearance of sex hormones due to inhibition of enzymes can increase the exposure of dienogest, which can lead to the development of 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. Such drugs include: phenytoin, barbiturates, primidone, Carbamazepine and rifampicin; There are also suggestions regarding 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 be maintained for at least 4 weeks after cessation of therapy.
Substances that can inhibit enzymes:
Known inhibitors of CYP3A4, such as azole antifungals (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, c); 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, the development of a clinically significant interaction of Vizanne with the metabolism of other drugs with the participation of cytochrome P450 enzymes is unlikely.
Food interactions:
A standardized high-fat meal did not affect the bioavailability of Visanne.
Other types of interaction: 
Acceptance of gestagens can affect the results of some laboratory tests, including the biochemical parameters of the liver, thyroid, adrenal glands and kidneys, plasma concentrations of proteins, for example, lipid / lipoprotein fractions, carbohydrate metabolism parameters and clotting parameters. Changes usually do not go beyond the normal range.