Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Desogestrel; Ethinylestradiol
Gedeon Richter (UK) Ltd
G03AA09
Desogestrel; Ethinylestradiol
150microgram ; 30microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030100; GTIN: 5391512451189
BLOOD CLOTS IN A VEIN WHAT CAN HAPPEN IF A BLOOD CLOT FORMS IN A VEIN? • The use of combined hormonal contraceptives has been connected with an increase in the risk of blood clots in the vein (venous thrombosis). However, these side effects are rare. Most frequently, they occur in the first year of use of a combined hormonal contraceptive. • If a blood clot forms in a vein in the leg or foot it can cause a deep vein thrombosis (DVT). • If a blood clot travels from the leg and lodges in the lung it can cause a pulmonary embolism. • Very rarely a clot may form in a vein in another organ such as the eye (retinal vein thrombosis). WHEN IS THE RISK OF DEVELOPING A BLOOD CLOT IN A VEIN HIGHEST? The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same product or a different product) after a break of 4 weeks or more. After the first year, the risk gets smaller but is always slightly higher than if you were not using a combined hormonal contraceptive. When you stop Gedarel your risk of a blood clot returns to normal within a few weeks. WHAT IS THE RISK OF DEVELOPING A BLOOD CLOT? The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking. The overall risk of a blood clot in the leg or lung (DVT or PE) with Gedarel is small. • Out of 10,000 women who are not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year. • Out of 10,000 women who are using a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate about 5-7 will develop a blood clot in a year. • Out of 10,000 women who are using a combined hormonal contraceptive that contains desogestrel, such as Gedarel between about 9 and 12 women will develop a blood clot in a year. • The risk of having a blood clot will vary according to your perso Citiți documentul complet
OBJECT 1 GEDAREL 30/150 MICROGRAM FILM-COATED TABLETS Summary of Product Characteristics Updated 02-Oct-2017 | Consilient Health Ltd 1. Name of the medicinal product Gedarel 30/150 microgram film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 30 micrograms ethinylestradiol and 150 micrograms desogestrel. Excipient with known effect: 64,3 mg lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet White, or almost white, round shaped, biconvex film-coated tablets of 6 mm diameter, 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 Gedarel should take into consideration the individual woman's current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Gedarel 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 GEDAREL The tablets must be taken in the order directed on the package every day at about the same time of the day. One tablet is 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 last tablet and may not have finished, before the next pack is started. HOW TO START GEDAREL _No preceding hormonal contraceptive use [in the past month]_ The tablet intake should be started on day 1 of the normal menstrual cycle (i.e. on the first day on which the woman has a menstrual bleeding). Tablet intake is also allowed to start on day 2-5, but during the first cycle concurrent use of a barrier method for the first 7 days of tablet intake is advisable. _Changing from a combined oral contraceptive (COC), combined contraceptive vaginal ring or _ _transdermal patch_ The woman should start taking Gedarel on the day after the last active tab Citiți documentul complet