ETHINYLESTRADIOL / DROSPIRENONE LEON FARMA & PLACE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
14-05-2024
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Active ingredient:
DROSPIRENONE ETHINYLESTRADIOL
Available from:
Rowex Ltd
Dosage:
0.03 / 3 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2012-03-30
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ethinylestradiol / Drospirenone Leon Farma & Placebo 0.03 mg/3 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
YELLOW TABLETS (ACTIVE TABLETS):
Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone
Excipients:
Lactose monohydrate 62 mg
WHITE TABLETS (PLACEBO TABLETS)
The tablet does not contain active substances
Excipient:
Lactose, anhydrous 89.5 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: Yellow, round film-coated tablets.
Placebo tablets: White, 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 & PLACEBO 0.03 MG/3 MG 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.
Tablet taking is continuous. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started the
day after the last tablet the previous pack. Withdrawal bleeding usually starts on day 2-3 after starting the placebo
tablets (last row) and may not have finished before the next pack is started.
HOW TO START ETHINYLESTRADIOL / DROSPIRENONE LEON FARMA & PLACEBO 0.03 MG/3 MG 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 & Placebo 0.03 mg/3 mg Film-coated Tablets on
the
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