Diyenogest Zentiva – hormone of gonads and the medicament used at pathology of genitals.

Indications – treatment of endometriosis.

Structure

• active ingredient: diyenogest;
• 1 tablet, film coated, contains the diyenogest 2 mg;
• other components: lactose, monohydrate, starch corn, povidone (K-30), sodium krakhmalglikolit (type A), magnesium stearate;
• film cover: Akwa Polish white 014.17MS, containing a gipromeloza (E 464), hydroxypropyl cellulose (E 463), talc (E 553b), the cottonseed oil hydrogenated the titan dioxide (E 171).

Contraindication

Drug Diyenogest Zentiva should not be used in the presence of any of following states or diseases. This information is partially obtained on the basis of use of other medicines containing only progestogen. If any of these states or diseases arises for the first time at use of the medicine Diyenogest Zentiva, administration of medicament should be stopped immediately.

• Venous thrombembolia in an active form.
• Arterial or cardiovascular diseases now or in the anamnesis (for example, a myocardial infarction, a cerebrovascular event, coronary heart disease).
• Diabetes with defeat of vessels.
• Serious illness of a liver now or their existence in the anamnesis until indicators of function of a liver return to norm.
• Tumour of a liver now or in the anamnesis (benign or malignant).
Are known to
• or the suspected malignant tumors depending on sex hormones.
• Vaginal bleeding of the obscure etiology.
• Hypersensitivity to active ingredient or any of medicine components.

Side reactions

Side reactions most often develop within the first months of application of the diyenogest and disappear in the course of treatment. Changes of nature of bleedings, such as krovomazany, irregular bleedings or amenorrhea can be observed.

It was reported about the subsequent side reactions at treatment diyenogesty. By-effects about most of which often reported during treatment diyenogesty include a headache (9.0%), discomfort in mammary glands (5.4%), oppressed mood (5.1%) and an acne (5.1%).

Besides, treatment diyenogesty affects the nature of menstrual bleedings at most of women. The nature of menstrual bleedings was systematically estimated with use of diaries of patients and analyzed using a method of WHO during the 90-day reporting period. In the first 90 days of therapy by medicine observed the following natures of bleedings: amenorrhea (1.7%), infrequent bleedings (27.2%), frequent bleedings (13.4%), irregular bleedings (35.2%), long bleedings (38, 3%), normal menstrual bleeding, that is any of the previous categories (19.7%). During the fourth reporting period the following natures of bleedings were observed: an amenorrhea (28.2%), rare bleedings (24.2%), frequent bleedings (2.7%), irregular bleedings (21.5%), long bleedings (4.0%) of %), the normal menstrual bleeding that is which is not relating to one of the previous categories (22.8%).

Route of administration

For oral administration.

on 1 tablet every day without interruption in use of medicine approximately at the same time, washing down with a small amount of liquid. A pill can be taken irrespective of food.

should take the Pill regularly irrespective of menstrual bleeding. As soon as tablets from one packing ended, to begin to take a pill from the following packing, without taking a break in use of medicine.

does not have experience of medicament treatment Diyenogest Zentiva of patients with endometriosis longer than 15 months.

in any day of a menstrual cycle.

Use of any hormonal contraceptives should be stopped before therapy by the medicine Diyenogest Zentiva. If contraception is necessary, it is necessary to apply in addition a non-hormonal method of prevention of pregnancy (for example, a barrier method).

Admission of intake of medicine

in case of the admission of reception of a tablet, vomiting and/or diarrhea (taking place within 3-4 hours after reception of a tablet), the efficiency of the medicine Diyenogest Zentiva can decrease. At the admission of reception of one or several pill of medicine it is necessary to take one tablet as soon as the woman remembers it, and following to accept in usual time. Similarly, the tablet which is not absorbed because of vomiting or diarrhea should be replaced with other tablet.

Use during pregnancy or feeding by a breast

Diyenogest Zentiva is not recommended to apply

Feature of application

. It is unknown whether gets diyenogest into breast milk of the woman. The data obtained in the course of the researches on animals indicate penetration of the diyenogest into breast milk. It is necessary to make the decision on the feeding termination by a breast or the therapy termination by the medicine Diyenogest Zentiva, considering advantage of feeding by a breast for the child and need of therapy for the woman.

On the basis of the available data that the menstrual cycle returns to normal within 2 months after the medicament treatment termination Diyenogest Zentiva.

Children

Diyenogest Zentiva is contraindicated to children to the first periods.

Use of the medicine Diyenogest Zentiva to teenagers during the period of treatment of 12 months was associated with decrease in the MSKT average value in lumbar department of a backbone for 1.2%. After the termination of treatment MSKT raised at these patients again.

Disturbance of MSKT is important especially at teenage age and the early period of puberty, a critical period of growth of bones. It is not known whether will reduce peak bone weight and will increase risk of a bone fracture at advanced age of lowering of MSKT in this population.

Therefore to the doctor should consider advantages of use of the medicine Diyenogest Zentiva and possible risks of application to each certain teenager.

Ability to influence speed of response at control of motor transport or other mechanisms

did not observe influence on ability to steer motor transport and to operate mechanisms at the patients taking the medicaments containing diyenogest.

Researches of acute toxicity conducted with diyenogesty did not indicate

risk of development of acute side reactions in case of inadvertent reception of several daily therapeutic doses. No specific antidotes exist. Use of 20-30 mg of the diyenogest within more than 24 weeks was transferred to day (is 10-15 times higher, than a dose in the tablet Diyenogesta Zentiva) very well.

Storage conditions

does not demand special storage conditions.

out of children's reach.