Šalis: Didžioji Britanija
kalba: anglų
Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)
Estradiol; Norethisterone acetate
Dowelhurst Ltd
G03CA53
Estradiol; Norethisterone acetate
2mg ; 1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040101
Code start Code: 100% Direction Length: Max. 29 mm (100%) Code start Code: 100% Direction Length: Max. 29 mm (100%) 8-2850-01-001-4 PACKAGE LEAFLET: INFORMATION FOR THE USER KLIOFEM® 2 MG/1 MG FILM-COATED TABLETS Estradiol/norethisterone acetate READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. history. Your doctor may decide to perform a physical examination. This may include an examination of your breasts and/or an internal examination, if necessary. Once you have started on Kliofem® you should see your doctor for regular check-ups (at least once a year). At these check-ups, discuss with your doctor the benefits and risks of continuing with Kliofem®. Go for regular breast screening, as recommended by your doctor. DO NOT TAKE KLIOFEM® If any of the following applies to you. If you are not sure about any of the points below, TALK TO YOUR DOCTOR before taking Kliofem®. Do not take Kliofem®: • if you have, have had or suspect having BREAST CANCER • if you have, have had or suspect having CANCER OF THE WOMB LINING (endometrial cancer), or any other oestrogen dependent cancer • 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 (venous thromboembolism), 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 previously have had a disease caused by blood clots in the arteries, such as a HEART ATTACK, STROKE or ANGINA • if you have or have ever had a LIVER DISEASE and your Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kliofem® film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH FILM-COATED TABLET CONTAINS: Estradiol 2 mg (as estradiol hemihydrate) and norethisterone acetate 1 mg. Excipient with known effect: lactose monohydrate. Each white film-coated tablet contains lactose monohydrate 36.3 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. White, film-coated, biconvex tablets, engraved with NOVO 281. Diameter 6 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women with more than 1 year since last menses. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of or contraindicated for other medicinal products approved for the prevention of osteoporosis (see section 4.4). The experience treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Kliofem is a continuous combined HRT product intended for use in women with an intact uterus. One tablet should be taken orally once a day without interruption, preferably at the same time every day. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see section 4.4) should be used. In women with amenorrhoea and not taking HRT or women in transition from another continuous combined HRT product, treatment with Kliofem may be started on any convenient day. In women in transition from a sequential HRT regimen, treatment should start right after their withdrawal bleeding has ended. If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next 12 hours. If more than 12 hours have passed, the tablet should be discarded. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting. 4.3 CONTRAINDICATIONS − Known, past or suspected breast cancer − Known Perskaitykite visą dokumentą