Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
ESTRADIOL HEMIHYDRATE DYDROGESTERONE
Abbott Healthcare Products Ltd
2 mg, 10 m Milligram
Film Coated Tablet
1997-10-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Femoston 2/10mg film-coated tablets. 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 one tablet contains estradiol hemihydrate equivalent to 2 mg estradiol and 10 mg dydrogesterone (yellow tablets). Excipients: Each brick-red tablet contains 118.2mg of lactose monohydrate. Each yellow tablet contains 109.4 mg of lactose monohydrate. For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Estradiol tablets only: Round, biconvex, brick-red, film-coated tablet with inscription‘379’ on one side. Estradiol/ Dydrogesterone combination tablets: Round, biconvex, yellow, 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 in treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Femoston 1/10, and Femoston 2/10, are continuous sequential HRTs. 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. For the first 14 days during a 28-cycle, one tablet containing estradiol is taken daily; during the following 14 days one tablet containing Aqra d-dokument sħiħ