Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
ethinylestradiol, gestodene
Gedeon Richter PLC
G03AA10
ethinylestradiol, gestodene
0,02mg+ 0,075mg
tablets coated
(21/1x21/) in blister, (63/3x21/) in blister
Prescription
Registered
2023-06-21
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT LINDYNETTE 20 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablets contains: _ACTIVE SUBSTANCES:_ 0,075 mg of gestodene and 0,02 mg of ethinylestradiol in each coated tablet. _EXCIPIENTS: _Sodium calcium edetate, magnesium stearate, silica colloidal anhydrous, povidone K-30, maize starch, lactose monohydrate _Film-coating:_ Quinoline” Yellow (E 104), povidone K-90F, titanium dioxide (E171), macrogol 6000, talc, calcium carbonate, sucrose. _ _ 3. PHARMACEUTICAL FORM Pale yellow, round, biconvex sugar-coated tablets, without sign on the both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Lindynette should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Lindynette compares with other combined hormonal contraceptives (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Pregnancy should be excluded before starting Lindynette. Posology The tablets must be taken every day at about the same time, in the order shown on the blister pack. One tablet is to be taken daily for 21 consecutive days, which is followed by a 7-day tablet-free interval. Each subsequent pack is started the day after the tablet-free interval. Withdrawal bleeding usually starts on the 2 nd or 3 rd day after taking the last tablet, and may not stop before the next pack is started. HOW TO START LINDYNETTE No hormonal contraceptive use within the preceding month The user should begin taking Lindynette on day 1 of her natural menstrual cycle (i.e. the first day of the menstrual bleeding). Beginning Lindynette use on days 2-7 of the menstrual cycle (e.g. starting on a Sunday) is also allowed; however a non-hormonal back-up method of birth control [e.g. condoms, spermicide] is recommended during the first 7 days of Lindynette 20 use. Switching from another combined contraceptive _(combined oral contraceptives Прочитать полный документ