Visanne tablets are indicated for the treatment of endometriosis.
Active ingredient: dienogest;
1 tablet contains dienogest 2 mg;
Excipients: lactose, potato starch, microcrystalline cellulose, povidone K 25, talc, crospovidone, magnesium stearate.
Visanne should not be used in the presence of any of the following conditions or diseases. This information is based in part on the use of other progestogen-only preparations. If any of these conditions or diseases occurs for the first time during the use of the preparation Visanne, the preparation should be stopped immediately.
Venous thromboembolism in an active form.
History of arterial or cardiovascular disease (eg myocardial infarction, cerebrovascular event, ischemic heart disease).
Diabetes mellitus with vascular damage.
Current or history of severe liver disease while liver function tests are not normal.
History of liver tumors (benign or malignant).
Or supposed malignant tumors dependent on sex hormones.
Vaginal bleeding of unknown etiology.
Hypersensitivity to the active substance or to any of the components of the preparation.
For oral use.
In case of missing a tablet, vomiting and / or diarrhea (which occurred during
3-4 hours after taking the tablet), the effectiveness of Visanne may decrease. If one or more tablets are missed, 1 tablet should be taken as soon as the woman remembers about it, and the next one should be taken at the usual time. Likewise, a tablet that is not absorbed through vomiting or diarrhea should be replaced with another tablet.
pregnant
Not recommended for use.
Children
Visanne is not indicated for use in children before menarche.
Drivers
Does not affect.
Acute toxicity studies conducted with dienogest did not indicate the risk of developing acute adverse reactions in case of inadvertent administration of several daily therapeutic doses. There are no specific antidotes. The use of 20-30 mg of dienogest per day (which is 10-15 times higher than the dose in the tablet of Visanne) for more than 24 weeks was very well tolerated.
Weight gain, depressed mood, sleep disturbance, nervousness, decreased libido, mood changes, headache, migraine, nausea, abdominal pain, flatulence, bloating, vomiting, acne, alopecia, back pain, breast discomfort, cyst ovaries, hot flashes, uterine/vaginal bleeding, asthenic conditions, irritability.
Based on the data of in vitro inhibition studies, the development of a clinically significant interaction of Visanne with the metabolism of other preparations with the participation of enzymes of the cytochrome P450 system is unlikely.
The intake of progestogens may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma protein concentrations, for example, lipid / lipoprotein fractions, parameters of carbohydrate metabolism and coagulation parameters. Changes usually do not go beyond the boundaries of normal values.
Store at a temperature not exceeding 30°C.
Keep out of the reach of children!
Shelf life - 5 years.