Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DESOGESTREL; ETHINYLOESTRADIOL
ORGANON MALAYSIA SDN. BHD.
DESOGESTREL; ETHINYLOESTRADIOL
21 Tablet Tablets
N.V. ORGANON
_Consumer Medication Information Leaflet (RiMUP) _ MARVELON ® Ethinylestradiol/Desogestrel (0.030mg/0.150mg) 1 Copyright 2021 Organon group of companies. All rights reserved. WHAT IS IN THIS LEAFLET 1. What MARVELON is used for 2. How MARVELON works 3. Before you take MARVELON 4. How to take MARVELON 5. While you are taking MARVELON 6. Side effects 7. Storage and Disposal of MARVELON 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11.Serial number WHAT MARVELON IS USED FOR MARVELON is a combined oral contraceptive (‘the combined Pill’). Each tablet contains a small amount of two different female hormones. These are desogestrel (a progestogen) and ethinylestradiol (an estrogen). Because of the small amounts of hormones, MARVELON is considered a low-dose oral contraceptive. As all tablets in the pack combine the same hormones in the same dose, it is considered a monophasic combined oral contraceptive. MARVELON is used to prevent pregnancy. When taken correctly (without missing tablets), the chance of becoming pregnant is very low. HOW MARVELON WORKS MARVELON releases two female sex hormones that prevents the release of an egg cell from the ovaries. If no egg is released you cannot become pregnant. BEFORE YOU TAKE MARVELON _-_ _ _ _When you must not use it _ _ _ Do not use the MARVELON if you have any of the conditions listed below. If anything on this list applies to you, tell your doctor before starting to use MARVELON. Your doctor may advise you to use a different type of Pill or an entirely different (non- hormonal) method of birth control. • If you have, or have had in the past a blood clot (thrombosis) in a blood vessel of the leg, lung (embolus) or other organs. • If you have or have had in the past a heart attack or stroke. • If you have or have ever 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 Read the complete document
MARVELON LPC-OG8276A -TB-112021 TABLET 1. NAME OF THE MEDICINAL PRODUCT MARVELON, tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.150 mg desogestrel and 0.030 mg ethinylestradiol Excipient: lactose < 80 mg For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Tablets for oral use. Tablets are round, biconvex and 6 mm in diameter. They are coded on one side TR above 5 and on the reverse side Organon*. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral Contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 4.2.1 HOW TO TAKE MARVELON 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 2-3 days after the last tablet and may not have finished before the next pack is started. 4.2.2 HOW TO START TAKING MARVELON _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 MARVELON 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 interval or following the last placebo tablet of her previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start using MARVELON preferably on the day of removal, but at the latest when the next application would have been due. If the woman has been using her previous method consistentl Read the complete document