Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE
Abbott Healthcare Products Ltd
1 Milligram
Film Coated Tablet
1999-04-16
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 estrogen deficiency symptoms in menopausal women. 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 of treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Fematab is an estrogen only continuous HRT for women with or without a uterus. In women with a uterus, a progestagen such as Dydrogesterone 10mg, should be added to Fematab for 12-14 days each month to reduce the risk to the endometrium. Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women. In general, treatment should start with Fematab 1mg. Depending on the clinical response, the dosage can afterwards be adjusted to individual need. If the complaints linked to estrogen deficiency are not ameliorated the dosage can be increased by using Fematab 2mg. The dosage is one tablet per day. Fematab should be taken continuously without a break between packs. Fematab can be taken with or without food. Starting Fematab In women who are not taking hormone replacement therapy, have established amenorrhoea, are hysterectomised, o Izlasiet visu dokumentu