Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ESTRADIOL DYDROGESTERONE
Abbott Healthcare Products Ltd
0.5/2.5 Milligram
Film Coated Tablet
2010-10-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Femoston-conti 0.5mg/2.5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.5 mg estradiol (as hemihydrate) and 2.5 mg dydrogesterone. Excipient(s): Lactose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. A round, biconvex marked 379 on one side (7mm). Yellow 0.5/25. mg tablets 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in post-menopausal women_._ Femoston-Conti 0.5mg/2.5mg should be used only in women more than 12 months post-menopausal. The experience in treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION There is no relevant use of Femoston-Conti 0.5mg/2.5mg in children and adolescents. Femoston-Conti 0.5mg/2.5mg is a continuous combined HRT for oral use. The dosage is one tablet per day. Femoston-Conti 0.5mg/2.5mg should be taken continuously without a break between packs. Femoston-Conti 0.5mg/2.5mg can be taken with or without food. Starting Femoston-Conti 0.5mg/2.5mg: Women experiencing a natural menopause should commence treatment with Femoston-Conti 0.5mg/2.5mg not earlier than at least 12 months after their last natural menstrual bleed. For surgically induced menopause, treatment may start immediately. In women who are not taking hormone replacement therapy or women, who switch from a continuous combined hormone replacement therapy, treatment may be started on any convenient day. In women transferring from a cyclic or continuous sequential HRT regimen, treatment should begin the day following completion of the prior regimen. If a dose has been forgotten, it should be taken as soon as possible. When more than 12 Read the complete document