Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE DYDROGESTERONE
Abbott Healthcare Products Ltd
ESTRADIOL HEMIHYDRATE DYDROGESTERONE
1/5 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ _FEMUREST CONTI 1MG/5MG, _FILM-COATED TABLETS Active substances: estradiol/dydrogesterone READ ALL OF THIS 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. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. The full name of your medicine is Femurest conti 1mg/5mg. In this leaflet the shorter name Femurest conti is used. WHAT IS IN THIS LEAFLET: 1. What Femurest conti is and what it is used for 2. What you need to know before you take Femurest 3. How to take Femurest 4. Possible side effects 5. How to store Femurest 6. Contents of the pack and other information 1. WHAT FEMUREST CONTI IS AND WHAT IT IS USED FOR Femurest conti is a Hormone Replacement Therapy ( HRT). It contains two types of female hormones, an oestrogen called estradiol and a progestogen called dydrogesterone. Femurest conti is used in postmenopausal women with at least 12 months since their last natural period. WHAT FEMUREST CONTI IS USED FOR RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). Femurest conti alleviates these symptoms after menopause. You will only be prescribed Femurest conti if your symptoms seriously hinder your daily l Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Femurest-conti 1 mg/5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 1 mg 17 -estradiol (as hemihydrate) and 5 mg dydrogesterone. Excipient(s) with known effect: lactose monohydrate 114.7mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated 'tablet' Round, biconvex marked 379 on one side (7mm) Salmon coloured 1/5 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. 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 also section 4.4) The experience in treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Femurest-conti 1 mg/5 mg is a continuous combined HRT for oral use. The oestrogen and the progstogen are given every day without interruption. The dosage is one tablet per day for a 28 day cycle. Femurest-conti 1 mg/5 mg 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 Femurest-conti 1 mg/5 mg depending on the time since menopause and severity of symptoms. Women experiencing a natural menopause should commence treatment with Femurest-conti 1 mg/5 mg 12 months after their last natural menstrual bleed. For surgically induced menopause, treatment may start immediately. Depending on the clinical respons Read the complete document