Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Estradiol; Dydrogesterone
IMED Healthcare Ltd.
G03FA; G03FA14
Estradiol; Dydrogesterone
Film-coated tablet
Progestogens and estrogens, fixed combinations; dydrogesterone and estrogen
2022-12-02
PACKAGE LEAFLET: INFORMATION FOR THE USER FEMOSTON ® -CONTI 1 MG/5 MG FILM-COATED TABLETS 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. See section 4. The full name of your medicine is Femoston-conti 1mg/5mg film-coated tablets. In this leaflet the shorter name Femoston is used. WHAT IS IN THIS LEAFLET: 1. What Femoston is and what it is used for 2. What you need to know before you take Femoston 3. How to take Femoston 4. Possible side effects 5. How to store Femoston 6. Contents of the pack and other information 1. WHAT FEMOSTON IS AND WHAT IT IS USED FOR Femoston is a Hormone Replacement Therapy (HRT). It contains two types of female hormones, an oestrogen called estradiol and a progestogen called dydrogesterone. Femoston is used in postmenopausal women with at least 12 months since their last natural period. FEMOSTON 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"). Femoston alleviates these symptoms after menopause. You will only be prescribed Femoston if your symptoms seriously hinder your daily life. PREVENTION OF OSTEOPOROSIS After the menopause some women may develop fragile bones (osteoporosis). You should discuss all available options with your doctor. If you are at an increased risk of fractures due to osteoporosis and other medicines are not suitable for you, you can use Femoston to prevent osteoporosis after menopause. 2. WHAT YOU NEED T Les hele dokumentet
Health Products Regulatory Authority 02 December 2022 CRN00CRLJ Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Femoston-conti 1 mg/5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains estradiol hemihydrate equivalent to 1 mg estradiol 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. _Product imported from Bulgaria_ Round, biconvex marked 379 on one side. Salmon coloured tablets. 4 CLINICAL PARTICULARS As per PA2010/012/004 5 PHARMACOLOGICAL PROPERTIES As per PA2010/012/004 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Tablet core: Lactose monohydrate Hypromellose Maize starch Colloidal anhydrous silica Magnesium stearate Film coat: Hypromellose Macrogol 400 Titanium dioxide (E171) Iron oxides, yellow and red (E172) 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf-life expiry date of this product shall be the date shown on the container and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicine does not require any special storage conditions. Health Products Regulatory Authority 02 December 2022 CRN00CRLJ Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER The tablets are packaged in blisters of 28 tablets. The blister made of PVC/PVOC or PVC film and covered with aluminium foil. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL This medicinal product may pose a risk to the aquatic environment. Medicines no longer required should not be disposed of via wastewater or household waste. Any unused product or waste material should be disposed of in accordance with local requirements or returned to the pharmacy. 7 PARALLEL PRODUCT AUTHORISATION HOLDER IMED Healthcare Ltd, Unit 625 Kilshane Avenue, Northwest Business Park, Ballycoolin, Dublin 15, Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA1463/189/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date Les hele dokumentet