Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
dienogest (micronised)
Bayer Weimar GmbH & Co. KG
dienogest (micronised)
2mg
tablets
Prescription
Visanne NL/H/1569/001/II/020_SmPC EU common proposed clean Sep 2015 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Visanne 2 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg dienogest Excipient with known effect: each tablet contains 62.8 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets White to off-white, round, flat-faced, bevelled-edge tablets with a debossed “B” on one side and a diameter of 7 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of endometriosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Method of administration: _ For oral use. _Posology _ The dosage of Visanne is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. The tablet can be taken with or without food. Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption. There is no experience with Visanne treatment > 15 months in patients with endometriosis. Treatment can be started on any day of the menstrual cycle. Any hormonal contraception needs to be stopped prior to initiation of Visanne. If contraception is required, non-hormonal methods of contraception should be used (e.g. barrier method). _Management of missed tablets: _ Visanne NL/H/1569/001/II/020_SmPC EU common proposed clean Sep 2015 2 The efficacy of Visanne may be reduced in the event of missed tablets, vomiting and/or diarrhea (if occuring within 3-4 hours after tablet taking). In the event of one or more missed tablets, the woman should take one tablet only, as soon as she remembers, and should then continue the next day at her usual time. A tablet not absorbed due to vomiting or diarrhea should likewise be replaced by one tablet. _ADDITIONAL INFORMATION ON SPECIAL POPULATIONS _ _Paediatric population: _ Visanne is not indicated in children prior to menarche The safety and efficacy of Visanne was investigated Прочитать полный документ