Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESTRADIOL HEMIHYDRATE; DYDROGESTERONE
ABBOTT LABORATORIES (M) SDN. BHD.
ESTRADIOL HEMIHYDRATE; DYDROGESTERONE
28tablet Tablets
Abbott Biologicals B.V., Veerweg
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ FEMOSTON® CONTI 0.5MG/2.5MG FILM-COATED TABLET Estradiol hemihydrate (0.5mg), dydrogesterone (2.5mg) Page no. 1 WHAT IS IN THIS LEAFLET 1. What Femoston® Conti is used for 2. How Femoston® Conti works 3. Before you use Femoston® Conti 4. How to use Femoston® Conti 5. While you are using it 6. Side effects 7. Storage and disposal of Femoston® Conti 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT FEMOSTON® CONTI IS USED FOR Femoston® Conti is used in postmenopausal women with at least 12 months since their last natural period to relief symptoms such as hot flushes. HOW FEMOSTON® CONTI WORKS Femoston® Conti acts as a hormone replacement therapy by providing two types of female hormones, an oestrogen called estradiol and a progestogen called dydrogesterone. BEFORE YOU USE FEMOSTON® CONTI _- When you must not use it_ Do not take Femoston® Conti if: • If you have or have ever had breast cancer, or if you are suspected of having it if you have cancer which is sensitive to oestrogens, such as cancer of the womb lining (endometrium), or if you are suspected of having it. • if you have or your doctor thinks you might have a tumor that is dependent on progestogens. An example is a tumor in the brain (meningioma). • if you have any unexplained vaginal bleeding • if you have excessive thickening of the womb lining (endometrial hyperplasia) that is not being treated • if you have or have ever had a blood clot in a vein (thrombosis) such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism) • if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency) • if you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina • you have or have ever had a liver disease and your liver function tests have not returned to normal • if you are allergic (hypersensitive) to estradiol, dydrogesterone Les hele dokumentet
1. NAME OF THE MEDICINAL PRODUCT Femoston Conti 0.5mg/2.5mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 28 tablets, each containing 0.5 mg 17β-estradiol (as hemihydrate) and 2.5 mg dydrogesterone. Excipient(s): Lactose monohydrate For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet A round, biconvex, marked 379 on one side. Yellow 0.5/2.5 mg tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 12 months since last menses. Elderly population The experience in treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. Femoston Conti 0.5mg/2.5mg is a continuous combined HRT for oral use. The oestrogen and the progestogen are given every day without interruption. The dosage is one tablet per day for a 28 day cycle. Femoston Conti 0.5mg/2.5mg should be taken continuously without a break between packs. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also section 4.4) should be used. Continuous combined treatment may be started with Femoston Conti 0.5 mg/2.5mg depending on the time since menopause and severity of symptoms. Women experiencing a natural menopause should commence treatment with Femoston Conti 0.5 mg/2.5mg not earlier than at least 12 months after their last natural menstrual bleed. For surgically induced menopause, treatment may start immediately. Depending on the clinical response, the dosage can subsequently be adjusted. Patients changing from a continuous sequential or cyclical preparation should complete the 28 day cycle and then change to Femoston Conti 0.5mg/2.5mg. Patients changing from another continuous combined preparation may start therapy at any time. If a dose has been forgotten, it should be taken as soon as possible. If more than 12 hours have elapsed, treatment should be continued with the next tablet Les hele dokumentet