DIANETTE Coated Tablets 2 / 0.035 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
21-05-2024
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Active ingredient:
CYPROTERONE ACETATE ETHINYLESTRADIOL
Available from:
PCO Manufacturing
Dosage:
2 / 0.035 Milligram
Pharmaceutical form:
Coated Tablets
Authorization date:
1998-10-16
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dianette 2mg/35microgram Coated Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg cyproterone acetate and 35 micrograms ethinyloestradiol.
Excipients:
Lactose
Sucrose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet (Tablet).
Round, beige, sugar-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in the management of severe acne vulgaris, especially those forms which are accompanied by seborrhoea or by
inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica) in women.
Oral contraception for the woman suffering from the above.
Although Dianette 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
HOW TO TAKE DIANETTE
Dianette is to be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection.
Combined oral contraceptives when taken correctly have a failure rate of approximately 1 % per year.
Tablets must be taken in the order directed on the package every day at about the same time with some liquid as
needed. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after a 7-day tablet-free
interval, during which time a withdrawal bleed usually occurs. This usually starts on day 2 - 3 after the last tablet and
may not have finished before the next pack is started.
HOW TO START DIANETTE
• No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman's natural cycle (i.e. the first day of h
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