Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESOGESTREL; Ethinylestradiol; DESOGESTREL; Ethinylestradiol
Aspen Medical Products Malaysia Sdn Bhd
DESOGESTREL; Ethinylestradiol; DESOGESTREL; Ethinylestradiol
22 Tablets
CYNDEA PHARMA
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 GRACIAL TABLET Desogestrel / Ethinylestradiol (25 mcg / 40 mcg & 125 mcg / 30 mcg) WHAT IS IN THE LEAFLET 1. What GRACIAL Tablet is used for 2. How GRACIAL Tablet works 3. Before you take GRACIAL Tablet 4. How to take GRACIAL Tablet 5. While you are taking it 6. Side effects 7. Storage and Disposal of GRACIAL Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT GRACIAL TABLET IS USED FOR GRACIAL Tablet is used for contraception, to prevent pregnancy. When taken correctly (without missing tablets), the change of becoming pregnant is very low. HOW GRACIAL TABLET WORKS GRACIAL Tablet is a combined oral contraceptive. Each tablet contains a small amount of two different female hormones. These are desogestrel (a progestogen) and ethinylestradiol (an estrogen). Because of small amounts of hormones, GRACIAL Tablet is considered a low-dose oral contraceptive. As the two hormones in the blue tablets are combined in a different dose than in the white tablets, it is considered a combiphasic oral contraceptive. GRACIAL Tablet prevents the release of egg cell from the ovaries and causes changes in the cervical secretion, thus prevent pregnancy. BEFORE YOU TAKE GRACIAL TABLET - _When you must not take it_ Do not take GRACIAL Tablet if you have the following conditions listed below. If anything on this list applies to you, tell your doctor before starting GRACIAL Tablet. • If you have or had in the past of blood clots (thrombosis) in blood vessel of the leg, lung (embolus) or other organs. • If you have or had in the past a heart attack or stroke. • If you have or had a condition that may be a first sign of a heart attack (such as angina pectoris or chest pain) or stroke (such as transient ischaemic attack or small reversible stroke). • If you have a disturbance of blood clotting (e.g. protein C deficiency). • If you have major surgery (e.g. an operation) and your ability to move around is limited read_full_document
GRACIAL TABLET QUANLITATIVE AND QUANTITATIVE COMPOSITION • Each blue tablet contains 25 mcg desogestrel and 40 mcg ethinylestradiol. • Each white tablet contains 125 mcg desogestrel and 30 mcg ethinylestradiol. PHARMACEUTICAL FORM Tablets for oral use. Desogestrel/Ethinylestradiol 25mcg / 40mcg Tablets are blue, round and flat tablets with beveled edges with a diameter of 6 mm, coded TR / 9 on one side and blank on the other side. Desogestrel/Ethinylestradiol 125mcg / 30mcg Tablets are white, round and flat tablets with beveled edges with a diameter of 6 mm, coded TR / 8 on one side and blank on the other side. CLINICAL PARTICULARS INDICATIONS Contraception DOSAGE AND ADMINISTRATION METHOD OF ADMINISTRATION 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 22 consecutive days, starting with the blue tablets for 7 days, followed by the white tablets for 15 days. Each subsequent pack is started after a 6-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 TAKING GRACIAL _NO PRECEDING HORMONAL CONTRACEPTIVE USE [IN THE PAST MONTH] _ Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended in addition for the first 7 days of tablet-taking. _CHANGING FROM A COMBINED HORMONAL CONTRACEPTIVE (COMBINED ORAL CONTRACEPTIVE _ _(COC), VAGINAL RING, OR TRANSDERMAL PATCH) _ The woman should start with GRACIAL preferably on the day after the last active tablet (the last tablet containing the active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet interval of her previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start us read_full_document