PALANDRA Film Coated Tablet 0.03/3 Milligram
מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
מאפייני מוצר
(SPC)
07-05-2024
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מרכיב פעיל:
ETHINYLESTRADIOL DROSPIRENONE
זמין מ:
Bayer Limited
כמות:
0.03/3 Milligram
טופס פרצבטיות:
Film Coated Tablet
תאריך אישור:
2010-10-29
מאפייני מוצר
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Palandra 0.03 mg / 3 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.030 mg ethinylestradiol and 3 mg drospirenone
Excipient: lactose 46 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Light yellow, round tablet with convex faces, one side embossed with the letters "DO" in a regular hexagon
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use
HOW TO TAKE PALANDRA
The tablets must be taken every day at about the same time, if necessary with a little liquid, in the order shown on the
blister pack. 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 PALANDRA
•
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 a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or
transdermal patch)
The woman should start with Palandra preferably on the day after the last active tablet (the last tablet containing the
active substances) of her previous COC, but at the latest on the day following the usual tablet-free or placebo tablet
interval of her previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start using
Palandra preferably on the day of removal, but at the latest when the
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