GRACIAL 25/40 AND 125/30 MICROGRAM TABLETS.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
DESOGESTREL ETHINYLESTRADIOL DESOGESTREL ETHINYLESTRADIOL
Available from:
Organon (Ireland) Limited
Dosage:
25/40 and Microgram
Pharmaceutical form:
Tablets
Authorization date:
1995-05-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gracial 25/40 and 125/30 microgram Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each blue tablet contains 25 microgram desogestrel and 40 microgram ethinylestradiol.
Each white tablet contains 125 microgram desogestrel and 30 microgram ethinylestradiol.
Each tablet also contains approximately 85mg Lactose Monohydrate.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
The tablets are round, flat with bevelled edges and 6mm in diameter. They are coded on one side “Organon” and an
asterix “*” and the reverse side “TR” above “8” (white tablets or “TR” above “9” (blue tablets).
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Contraception.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Before starting Gracial
®,
a thorough general medical and gynaecological examination (including breasts and a
cytological smear of the cervix as appropriate) should be carried out and the family medical history carefully noted.
Disturbances of the clotting mechanisms should be ruled out if any members of the family have suffered from
thromboembolic diseases (eg deep vein thrombosis, stroke, myocardial infarction) at a young age.
Pregnancy must be excluded ideally by a pregnancy test.
As a precaution, thorough examinations should be conducted at approximately six month intervals during the use of the
tablets.
HOW TO TAKE GRACIAL
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 22 consecutive days, starting with the blue tablets for 7 days followed by the
white tablets for 15 days. Each subsequent pack is started after a 6-day tablet-free interval, during which time
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