LEVONORGESTREL/ETHINYLESTRADIOL FAMY CARE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-05-2024
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Active ingredient:
LEVONORGESTREL ETHINYLESTRADIOL
Available from:
Famy Care Europe Ltd
Dosage:
100/20 Microgram
Pharmaceutical form:
Coated Tablets
Authorization date:
2012-02-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levonorgestrel/Ethinylestradiol Famy Care 100 micrograms/20 micrograms coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains Levonorgestrel 100 micrograms and Ethinylestradiol 20 micrograms.
Excipients: 1 coated tablet contains 48 mg of lactose monohydrate and 14 mg of sucrose
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Coated tablet
Round, pink, 5.60 mm coated tablets
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
HOW TO USE LEVONORGESTREL/ETHINYLESTRADIOL FAMY CARE 100 MICROGRAMS / 20 MICROGRAMS COATED TABLETS
Tablets must be taken orally in the order directed on the blister package at about the same time every day, with some
liquid if necessary. 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.
The bleeding usually starts within 2 to 3 days after the last tablet and may not end before the next pack is started.
HOW TO START THE USE OF LEVONORGESTREL/ETHINYLESTRADIOL FAMY CARE 100 MICROGRAMS / 20 MICROGRAMS COATED
TABLETS
• no preceding hormonal contraceptive use (in the past month), tablet-taking is started on day 1 of the woman’s natural
cycle (i.e. the first day of her menstrual bleeding). Starting on days 2– 5 is allowed but in that case an additional barrier
method is recommended for the first 7 days of the first cycle
• Changing from another combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring,
transdermal patch)
The use of Levonorgestrel and Ethinylestradiol coated tablet is preferably started on the day after the last a
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