País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE
BGP Products Ltd
G03CA03
ESTRADIOL HEMIHYDRATE
1 Milligram
Film Coated Tablet
Oral use
28 tablets
Product subject to prescription which may not be renewed (A)
Abbott Biologicals B.V.
Natural and semisynthetic oestrogens, plain
Natural and semisynthetic estrogens, plain
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 6 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
Authorised
2015-03-27
Patient Information Leaflet FEMATAB 1MG & 2MG FILM-COATED TABLETS estradiol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Fematab is and what it is used for 2. Before you take Fematab 3. How to take Fematab 4. Possible side effects 5. How to store Fematab 6. Further information 1. What Fematab is and what it is used for WHAT FEMATAB IS The name of your medicine is Fematab. It belongs to a group of medicines called Hormone Replacement Therapy (HRT). Fematab contains a form of the female oestrogen hormone called estradiol. WHAT FEMATAB IS USED FOR Fematab is used in postmenopausal women with at least 6 months since their last natural period. • FOR THE RELIEF OF THE 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”). Fematab alleviates these symptoms after menopause. You will only be prescribed Fematab if your symptoms seriously hinder your daily life. • TO PREVENT THINNING OF THE BONES (OSTEOPOROSIS) IN POST MENOPAUSAL WOMEN 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 Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Fematab 1mg Film-coated tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains Estradiol Hemihydrate equivalent to 1 mg estradiol per tablet. Excipients - Contains Lactose Monohydrate 119.1mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White, round, biconvex, film-coated tablet with inscription '379' on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in postmenopausal women at least 6 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) Older people The experience of treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The initial daily dosage is 1 mg. The dosage may be increased to 2 mg if required. 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. Treatment of hysterectomised women and postmenopausal women may be started on any convenient day. If the patient is menstruating, treatment is started on day one of bleeding. In women with a uterus, a progestagen should be added to Fematab for 12-14 days each month/28 day cycle. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women. Fematab can be taken with or without food. 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 n Llegiu el document complet