Visan represents nortestosterone derivative, does not possess androgenic activity but having largely antiandrogenic effect, which is approximately one third of the activity of cyproterone acetate.
Dienogest binds to progesterone receptors in the human uterus, while having only 10% of the relative affinity of progesterone. Despite low affinity for progesterone receptors, dienogest is characterized by a strong progestagenic effect in vivo.
Dienogest does not have significant androgenic, glucocorticoid or mineralocorticoid activity in vivo.
Dienogest acts on endometriosis by reducing the endogenous production of estradiol and thereby suppressing its trophic effects on both eutopic and ectopic endometrium on. In continuous application creates hypoestrogenic dienogest, gipergestagennuyu endocrine environment causing initial decidualization of endometrial tissue with subsequent atrophy of endometriotic lesions.
Additional properties of dienogest such as immunological and angiogenic effects obviously contribute to its suppressive effect on cell proliferation.
Bayer Pharma AG, Germany
For women, adults on prescription
One tablet contains:
Treatment of endometriosis.
Visan should not be applied if any of the following conditions, which are partly taken from the information on other compositions containing gestagen component only. If any of these conditions develops on the background of Visan, the use of the drug should be discontinued immediately.
– Active venous thromboembolic condition;
– heart and vascular diseases (eg, myocardial infarction, stroke, coronary heart disease) now or in the past;
– diabetes mellitus with vascular complications;
– severe liver disease now or in the past, as long as indicators of hepatic function does not return to normal;
– liver tumors (benign or malignant), currently or in the past;
– the identified or suspected malignancy, sex steroid-dependent;
– vaginal bleeding of unknown origin;
– hypersensitivity to the active substance or to any of the excipients.
Adverse effects are more likely to arise in the first months of receiving Visan and their frequency is reduced during the drug treatment.
The following side effects were observed in women on the background of Visan.
The most frequently reported side effects during treatment visa which, at least, were considered as possibly related to administration of the drug, include: headache (9.0%), discomfort in the mammary gland (5.4%), mood decrease ( 5.1%) and acne (5.1%).
The following are unwanted drug reactions, distributed by Classes organ system according to MedDRA – Medical dictionary for regulatory activities.
Side effects in each frequency band are presented in order of decreasing frequency. Frequency indicators are based on pooled data from four clinical studies involving 332 patients (100%).
Often (≥1 / 100 iNechasto (≥1 / 1,000 to
How to accept, acceptance rate and dosage
For ingestion. Pills can start on any day of the menstrual cycle. Take one tablet per day without interruption, preferably at the same time each day, if necessary with some liquid. Tablets must be taken continuously, regardless of vaginal bleeding.
After the completion of one package begin receiving the next without tablet-free interval. Visan efficiency may decrease with passage of tablets, vomiting and / or diarrhea (if it occurs within 3-4 hours after ingestion of the tablet).
When you miss one or more pills, women should take only one tablet as soon as she remembers this, and then the next day to continue taking the tablets at the usual time. Due to unabsorbed vomiting or diarrhea tablet should be replaced additional reception of one tablet.
There is an appropriate indication for the use of Visan in elderly patients. There is no evidence pointing to the need for dose adjustment in patients with renal insufficiency.
At a temperature of not higher than 30 ° C
Individual inductors or enzyme inhibitors (isoenzyme CYP3A):
Progestins including dienogest, metabolized mainly involving cytochrome P450 3A4 (CYP3A4), localized in the intestinal mucosa and in the liver. Therefore, inducers or inhibitors of CYP3A4 may affect the metabolism gestagen preparations. Increased clearance of hormones, enzymes due to induction can lead to a decrease in therapeutic effect Visan and cause side effects, such as changing the nature of uterine bleeding.
Reduced clearance of sex hormones in connection with the inhibition of enzymes may increase the exposure of dienogest, which may lead to the development of side effects.
Substances capable of inducing enzymes:
The use of drugs that induce microsomal liver enzymes (e.g., cytochrome P450 enzyme system) can lead to increased clearance of sex hormones. These medicines include: phenytoin, barbiturates, primidone, carbamazepine and rifampicin; also has assumptions regarding oxcarbazepine, topiramate, felbamate, ritonavir and griseofulvin, nevirapine and preparations containing St. John’s wort. Maximal enzyme induction is generally observed not earlier than 2-3 weeks, but may then persist for at least 4 weeks following discontinuation of therapy.
Substances capable of inhibiting enzymes:
Known inhibitors of CYP3A4, such as azole antifungals (e.g., ketoconazole, itraconazole, fluconazole), cimetidine, verapamil, macrolides (e.g., erythromycin, clarithromycin and roxithromycin), diltiazem, protease inhibitors (e.g., ritonavir, saquinavir, indinavir, nelfinavir), antidepressants (e.g., nefazodone, fluvoxamine, fluoxetine) and grapefruit juice may increase the concentration of progestogens in plasma and lead to the development of side effects.
Effect on dienogest other medicinal substances:
From the data inhibition in vitro studies, it is unlikely development Visan clinically significant interaction with the metabolism of other drugs with the cytochrome P450 enzyme system.
Interaction with food:
A standardized meal with high-fat diet had no effect on the bioavailability of Visan.
Receiving progestogens can affect the results of some laboratory tests, including biochemical parameters of the liver, thyroid, adrenals and kidneys, plasma protein concentration, e.g., fractions of lipids / lipoproteins, carbohydrate metabolism parameters and coagulation parameters. Changes do not usually go beyond the normal range.
Before taking Visan necessary to exclude pregnancy. During reception Visan recommended hormonal contraceptive methods, if necessary patients contraception (e.g., barrier method).
If pregnancy occurred in women using birth control pills only progestin component (eg, minipill) greater than the probability of ectopic localization, compared with pregnancy that occurred in patients receiving combined oral contraceptives. Therefore, the application of Visan in women with ectopic pregnancy history or a dysfunction of the fallopian tubes should be decided only after careful evaluation of the benefits and risks.
Since Visan is a preparation with only progestin component, it can be assumed that the special warnings and precautions for use of other drugs with the progestin component, are also applicable for use Visan, although not all of the warnings and precautions are based on respective findings in the clinical studies Visan .
With or aggravation of any of the following conditions or risk factors, or continuation before receiving Visan should conduct an individual assessment of the risk / an advantage.