Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
desogestrel, ethinylestradiol
Gedeon Richter PLC
G03AA09
desogestrel, ethinylestradiol
0,15mg+ 0,03mg
tablets film-coated
(21/1x21/) in blister, (63/3x21/) in blister
Prescription
Registered
2022-08-22
1. NAME OF THE MEDICINAL PRODUCT Regulon 0.15 mg/0.03 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 0.15 mg of desogestrel and 0.03 mg of ethinylestradiol in each film-coated tablet. Excipient with known effect: The medicinal product contains 67.66 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. White, or almost white, round shaped, biconvex film-coated tablets with “P8” sign on one side and “RG” sign on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Regulon should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Regulon compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology HOW TO TAKE REGULON Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. HOW TO START REGULON _NO PRECEDING HORMONAL CONTRACEPTIVE USE (IN THE PAST MONTH) _ It is preferable that tablet intake from the first pack is started on the first day of menstruation in which case no extra contraceptive precautions are necessary. If menstruation has already begun, (that is 2, 3, or 4 days previously), tablet taking should commence on day 5 of the menstrual period. In this case additional contraceptive precautions must be taken for the first 7 days of tablet taking. If menstruation began more than 5 days previously then the patient should be advised to wait until her next menstrual period before starting to take Regulon. _CHANGING FROM A 21 DAY PILL OR ANOTH Прочитать полный документ