FEMOSTON 2/20 2 mg, 20 m %v/v Tablets
Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
Данни за продукта
(SPC)
07-05-2024
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Активна съставка:
ESTRADIOL HEMIHYDRATE DYDROGESTERONE
Предлага се от:
Abbott Healthcare Products Ltd
INN (Международно Name):
ESTRADIOL HEMIHYDRATE DYDROGESTERONE
дозиране:
2 mg, 20 m %v/v
Лекарствена форма:
Tablets
Статус Оторизация:
Withdrawn
Дата Оторизация:
2002-10-31
Данни за продукта
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
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