Pays: Suède
Langue: suédois
Source: Läkemedelsverket (Medical Products Agency)
dienogest
Mylan AB
G03DB08
dienogest
2 mg
Tablett
laktosmonohydrat Hjälpämne; dienogest 2 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 1 x 28 tabletter (kalenderförpackning); Blister, 3 x 28 tabletter (kalenderförpackning); Blister, 6 x 28 tabletter (kalenderförpackning)
Avregistrerad
2019-03-15
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Endofemine 2 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg dienogest Excipient with known effect: each tablet contains 60.9 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, round, tablets with a diameter of 5 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of endometriosis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology: _ The dosage ofis 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 Lire le document complettreatment >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 . If contraception is required, non-hormonal methods of contraception should be used (e.g. barrier method). _Management of missed tablets: _ 2 The efficacy of 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: _ is not indicated in children prior to menarche. The safety and efficacy of dienogest was investigated in an uncontrolled clinical trial over 12 months in 111 adolescent women (12-<18) with clinically suspected or confirmed endometriosis (see sections 4.4 and 5.1). _Geriatric population: _ There is no relevant