Country: Armenia
Language: English
Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
estradiol (estradiol hemihydrate), dydrogesterone
ABBOTT Biologicals B.V.
G03FA14
estradiol (estradiol hemihydrate), dydrogesterone
1mg+ 5mg
tablets film-coated
(28/1x28/) in blister
Prescription
Registered
2023-02-06
Abbott Confidential Information This information is confidential Estradiol - Dydrogesterone SOLID 1000323709 SUMMARY OF PRODUCT CHARACTERISTICS ESTRADIOL / DYDROGESTERONE Date of Previous Approval: 15 Jan 2013 Date of Approval: 15 Jan 2016 1 NAME OF THE MEDICINAL PRODUCT Femoston ® 1/5 conti, 1mg/5mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Femoston ® 1/5 conti, 1mg/5mg film-coated tablets 28 tablets, each containing 1 mg 17β-estradiol (as hemihydrate) and 5 mg dydrogesterone. 3 PHARMACEUTICAL FORM Film-coated tablet Round, biconvex tablets marked 379 on one side. 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. The experience in treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Femoston ® 1/5 conti, Continuous combined. For oral use. The oestrogen and the progestogen are given every day without interruption. One tablet to be taken daily for a 28 day cycle. Femoston ® 1/5 conti 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 should be used. Continuous combined treatment may be started with Femoston ® 1/5 conti depending on time since menopause and severity of symptoms. Depending on the clinical response, the dosage can subsequently be adjusted. Patients changing from another continuous sequential or cyclical preparation should complete the 28 day cycle and then change to Femoston ® 1/5 conti. Patients changing from a continuous combined preparation may start therapy at any time. If a dose has been forgotten, it should be taken as soon as possible. If mor Read the complete document