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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Estopause Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white tablet contains 2 mg of Oestradiol. Each pale blue tablet contains 2 mg of Oestradiol and 5 mg of
Medroxyprogesterone Acetate.
_For excipients see 6.1._
3 PHARMACEUTICAL FORM
Film-coated tablet.
Calendar pack consisting of 16 round, white, biconvex tablets and 12 round, pale-blue, biconvex tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) for estrogen deficiency symptoms. In post menopausal women with an
intact uterus.
Second line therapy for 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 of treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and elderly
Estopause is a continuous sequential combined HRT regimen (Oestrogen and Medroxyprogesterone). The
oestrogen phase (2mg oestrogen [17
oestradol] is given for the first 16 days. This is followed by a combined
oestrogen and progesterone acetate for 12 days.
The regimen is based on a 28 day cycle which one tablet is taken daily without interruption. One tablet of
oestrogen 2mg is taken daily for the first 16 days. This is followed by one tablet daily for the following 12 days of
combined tablet contains (oestrogen 2mg and medroxyprogesterone 5mg). In menstruating women or women
already on HRT, the first tablet should be taken in the fifth day of menstrual bleeding. If menstruating has stopped
or is infrequent or sporadic, the first tablet can be taken at any time.
Tablets should be taken approximately at the same
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