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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ethinylestradiol / Drospirenone Leon Farma 0.03 mg/3 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone
Excipient:
Lactose monohydrate 62 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round film-coated tablets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use.
HOW TO TAKE ETHINYLESTRADIOL / DROSPIRENONE LEON FARMA 0.03MG/3MG FILM-COATED TABLETS
The tablets must be taken every day at about the same time, if necessary with a little liquid in the order shown on blister
pack.
One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after 7-day tablet-free interval,
during which time withdrawal bleed 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 TAKE ETHINYLESTRADIOL / DROSPIRENONE LEON FARMA 0.03MG/3MG FILM-COATED TABLETS
·
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 her menstrual bleeding).
·
Changing from another combined oral contraceptive (COC)
The woman should start Ethinylestradiol / Drospirenone Leon Farma 0.03mg/3mg Film-coated Tablets on the day
following the usual hormone free interval (tablet-free or placebo tablet interval) of herprevious combined oral
contraceptive method.
In case a vaginal ring or transdermal patch has been used the woman should start using Ethinylestradiol / Drospirenone
Leon Farma 0.03mg/3mg Film-coated tablets preferably
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