Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Desogestrel
Gedeon Richter (UK) Ltd
G03AC09
Desogestrel
75microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030201; GTIN: 5391512452018
WHAT IS IN THIS LEAFLET 1. What Cerelle 75 microgram film-coated tablets (hereafter: Cerelle) is and what it is used for 2. What you need to know before you take Cerelle 3. How to take Cerelle 4. Possible side effects 5. How to store Cerelle 6. Contents of the pack and other information 1. WHAT CERELLE IS AND WHAT IT IS USED FOR This medicine is for the prevention of pregnancy. HOW DOES IT WORK? Cerelle contains a small amount of one type of female sex hormone, the progestogen, desogestrel. For this reason Cerelle is called a progestogen-only pill (POP) or mini-pill. Unlike the combined pill, the POP or mini-pill does not contain an oestrogen hormone, but only a progestogen. Most POPs or mini-pills work primarily by preventing the sperm cells from entering the womb but they do not always prevent the egg cell from ripening which is the primarily action of combined pills. Cerelle is distinct from other mini-pills in having a dose that in most cases is high enough to prevent the egg cell from ripening. As a result, Cerelle provides high contraceptive efficacy. In contrast to the combined pill, Cerelle can be used by women who do not tolerate oestrogens and by women who are breast-feeding. A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Cerelle. You also may not have any bleeding at all. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CERELLE Cerelle will not protect you against HIV infection (AIDS) and any other sexually transmitted diseases. DO NOT TAKE CERELLE Do not use Cerelle if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use Cerelle. Your doctor may advise you to use a non-hormonal method of birth control. • If you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6.). • If you have thrombosis. Thrombosis is the formation of a blood clot in a blood vessel, which may lead to obstruction of this blood vessel {e.g. of the legs (deep venous thrombosis), the lungs Soma hati kamili
OBJECT 1 CERELLE 75 MICROGRAMS FILM-COATED TABLETS Summary of Product Characteristics Updated 15-Mar-2018 | Consilient Health Ltd 1. Name of the medicinal product Cerelle 75 microgram film-coated tablets 2. Qualitative and quantitative composition One film-coated tablet contains 75 microgram desogestrel. Excipient with known effect: 52.34 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, biconvex film-coated tablets of about 5.5 mm in diameter, with a sign “D” on one side and “75” on the other side. 4. Clinical particulars 4.1 Therapeutic indications Contraception 4.2 Posology and method of administration Posology To achieve contraceptive effectiveness, Cerelle must be used as directed (see 'How to take Cerelle and 'How to start Cerelle). Special populations _Renal impairment_ No clinical studies have been performed in patients with renal impairment. _Hepatic impairment_ No clinical studies have been performed in patients with hepatic insufficiency. Since the metabolism of steroid hormones might be impaired in patients with severe hepatic disease, the use of Cerelle in these women is not indicated as long as liver function values have not returned to normal (see section 4.3). _Paediatric population_ The safety and efficacy of Cerelle in adolescents below 18 years has not yet been established. No data are available. Method of administration Oral use HOW TO TAKE CERELLE Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one. HOW TO START CERELLE _No preceding hormonal contraceptive use [in the past month]_ Tablet-taking has to start on day 1 of the woman's natural cycle (day 1 is the first day of he Soma hati kamili