Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE DYDROGESTERONE
Abbott Healthcare Products Ltd
ESTRADIOL HEMIHYDRATE DYDROGESTERONE
2 mg, 20 m %v/v
Tablets
Withdrawn
2002-10-31
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Femoston 2/20 mg tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION This product contains estradiol hemihydrate equivalent to 2 mg estradiol per tablet for the first 14 days of a 28-day cycle (brick-red tablets). For the second 14 days each tablet contains estradiol hemihydrate equivalent to 2 mg estradiol and 20 mg dydrogesterone (blue tablets). For excipients, see 6.1 3 PHARMACEUTICAL FORM Film-coated tablet. Round, biconvex, brick-red, film-coated tablet with 379 on one side and S on the other side. Round, biconvex, blue, film-coated tablet with 379 on one side and S on the other 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, special warnings and precautions for use) The experience in treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Femoston 2/20 is a continuous sequential HRT. In general, treatment should start with Femoston 1/10. 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 Femoston 2/10. If either early withdrawal bleeding occurs or if endometrial biopsy reveals inadequate progestational response the dosage can be increased by using Femoston 2/20. For the first 14 days during a 28-cycle, one tablet containing estradiol is taken daily; during the following 14 days one tablet containing est Přečtěte si celý dokument