CYPROTERONE ACETATE/ETHINYLESTRADIOL 2mg/35ug %v/v Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-05-2024
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Active ingredient:
CYPROTERONE ACETATE ETHINYLESTRADIOL
Available from:
Generics (UK) Limited
INN (International Name):
CYPROTERONE ACETATE ETHINYLESTRADIOL
Dosage:
2mg/35ug %v/v
Pharmaceutical form:
Tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cyproterone Acetate/Ethinylestradiol Tablets 2mg/0.035mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One coated tablet contains:
Cyproterone acetate 2.000 mg
Ethinylestradiol
0.035 mg
and also contains 31.115 mg of Lactose Monohydrate and 19.371 mg of Sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated Tablet.
Each tablet is round, beige in colour with no markings.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Cyproterone Acetate/ Ethinylestradiol Tablets 2mg/0.035mg is recommended for use in women only for the treatment
of:
- severe acne, refractory to prolonged antibiotic therapy or
- moderately severe hirsutism.
Although Cyproterone Acetate/Ethinylestradiol is recommended for use in women only for the treatment of (a) severe
acne, refractory to prolonged oral antibiotic therapy; (b) moderately severe hirsutism.
Although Cyproterone Acetate/Ethinylestradiol also acts as an oral contraceptive, it should not be used in women
solely for contraception, but should be reserved for those women requiring treatment for the androgen-dependent
conditions described.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Cypterone Acetate/Ethinylestradiol inhibits ovulation and thereby prevents conception. Patients who are using
Cyproterone Acetate/Ethinylestradiol should not therefore use an additional hormonal contraceptive, as this will expose
the patient to an excessive dose of hormones and is not necessary for effective contraception.
_First treatment course: _One tablet daily for 21 days, starting on the first day of the menstrual cycle (the first day of
menstruation counting as Day 1).
_Subsequent courses: _Each subsequent course is started after 7 tablet-free days have followed the preceding course.
When the
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