Maa: Ruotsi
Kieli: ruotsi
Lähde: Läkemedelsverket (Medical Products Agency)
drospirenon
Exeltis Healthcare, S.L.
G03AC10
drospirenone
4 mg
Filmdragerad tablett
laktos (vattenfri) Hjälpämne; laktosmonohydrat Hjälpämne; drospirenon 4 mg Aktiv substans
Receptbelagt
Förpacknings: Blister, 1 x 28 tabletter (kalenderförpackning); Blister, 3 x 28 tabletter (kalenderförpackning); Blister, 6 x 28 tabletter (kalenderförpackning); Blister, 13 x 28 tabletter (kalenderförpackning)
Godkänd
2019-11-18
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Droslind 4 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION White active film-coated tablets: Each tablet contains 4 mg of drospirenone. Green placebo film-coated tablets: The tablet does not contain active substances. Excipient with known effect: Each white active film-coated tablet contains 17.5 mg of lactose. Each green placebo film-coated tablet contains 52.7 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). The active tablet is a round, white tablet with the letters “E” and “D” debossed on opposite sides, with a diameter of 5 mm. The placebo tablet is a round, green tablet with the letter “E” and the number “4” debossed on opposite sides, with a diameter of 5 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Contraception 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology HOW TO TAKEOne tablet is to be taken daily for 28 consecutive days, one white active tablet daily during the first 24 days and one green inactive tablet daily during the 4 following days. Tablets must be taken every day at about the same time of the day so that the interval between two tablets is always 24 hours. Tablets should be taken in the order shown on the blister. Stickers marked with the 7 days of the week are provided. The woman should choose the sticker that starts with the day she begins taking the tablets and stick it on the blister. The first tablet of the treatment should be taken on the first day of menstrual bleeding. Thereafter tablet taking is continuous. A subsequent pack is started immediately after finishing the previous pack, without a break in daily tablet intake. 3 HOW TO START Lue koko asiakirja_No preceding hormonal contraceptive use (in the past month)_ Tablet-taking has to start on day 1 of the woman’s natural cycle (first day of her menstrual bleeding). When doing so, no additional contraceptive measure