Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DYDROGESTERONE; ESTRADIOL
ABBOTT LABORATORIES (M) SDN. BHD.
DYDROGESTERONE; ESTRADIOL
28Tablet Tablets
Abbott Biologicals B.V.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ FEMOSTON® CONTI 1MG/5MG FILM-COATED TABLET Estradiol (1mg), dydrogesterone (5mg) 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 to relief symptoms due to estrogen deficiency such as hot flushes in women who still have a uterus (womb). Femoston® Conti is also used to prevent osteoporosis in post- menopausal women who still have a uterus. 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 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, 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. • if you have any unexplained vaginal bleeding • if you have excessive thickening of the womb lining that is not being treated • if you have or have ever had a blood clot in a vein such as in the legs or the lungs • if you have a blood clotting disorder • if you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, or angina • if you have or have ever had a liver disease and your liver function tests have not returned to normal • if you have porphyria (a metabolic disorder) • if you are allergic (hypersensitive) to estradiol, dydrogesterone or to any of the other ingredients of Femoston® Conti. If you Lestu allt skjalið
1. NAME OF THE MEDICINAL PRODUCT Femoston 1/5 film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 28 tablets, each containing 1 mg 17β-estradiol (as hemihydrate) and 5 mg dydrogesterone. Excipient with known effect: lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Round, biconvex tablets marked 379 on one side. Salmon-coloured 1/5 mg tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormonal replacement therapy (HRT) for the relief of symptoms due to estrogen deficiency in women with a uterus. Prevention of postmenopausal osteoporosis in women with a uterus. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. The oestrogen and the progestogen are to be taken every day without interruption. One tablet is to be taken daily for a 28 day cycle. Femoston conti 1/5 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 Warnings & Precaution) should be used. Continuous combined treatment may be started with Femoston 1/5 depending on the time since menopause and the severity of the symptoms. Depending on the clinical response, the dosage can subsequently be adjusted. Patients changing from another continuous sequential or cyclical preparation should complete the 28- day cycle and then change to Femoston conti 1/5. Patients changing from a 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 without taking the forgotten tablet. The likelihood of breakthrough bleeding or spotting may be increased. Femoston conti 1/5 can be taken irrespective of food intake. Paediatric population: There is no relevant indication for the use of Femoston conti 1/5 in the paediatric population 4.3 CONTRAINDICATIONS • Known past or suspected br Lestu allt skjalið