Benifema 150 micrograms/30 micrograms, film-coated Tablets
Land: Malta
Språk: engelsk
Kilde: Malta Medicines Authority
Informasjon til brukeren
(PIL)
22-06-2024
Preparatomtale
(SPC)
22-06-2024
Aktiv ingrediens:
DESOGESTREL, ETHINYLESTRADIOL
Tilgjengelig fra:
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
ATC-kode:
G03AA09
INN (International Name):
DESOGESTREL 150 µg ETHINYLESTRADIOL 30 µg
Legemiddelform:
FILM-COATED TABLET
Sammensetning:
DESOGESTREL 150 µg ETHINYLESTRADIOL 30 µg
Resept typen:
POM
Terapeutisk område:
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Autorisasjon status:
Withdrawn
Autorisasjon dato:
2013-09-30
Informasjon til brukeren
Page 1 of 15
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENIFEMA 150 MICROGRAMS/30 MICROGRAMS FILM-COATED TABLETS
DESOGESTREL / ETHINYLESTRADIOL
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS):
• They are one of the most reliable reversible
methods of contraception if used correctly
• They slightly increase the risk of having a blood
clot in the veins and arteries, especially in
the
first year or when restarting a combined hormonal contraceptive following a break
of 4
or more weeks
• Please be alert and see your doctor if you think you
may have symptoms of a blood clot (see
section 2 “Blood clots”)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read it again.
• If you have any further questions,
ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do
not pass it on to others. It
may harm them.
• If you get any side effects, talk
to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Benifema is and what it is used for
2.
What you need to know before you take Benifema
3.
How to take Benifema
4.
Possible side effects
5.
How to store Benifema
6.
Contents of the pack and other information
1.
WHAT BENIFEMA IS AND WHAT IS USED FOR
Benifema are
a combined oral contraceptive, also called the pill.
Each of the 21 white tablets contains a small amount
of two types of female hormones, namely, a
progestogen desogestrel and an oestrogen, ethinylestradiol.
These help to
stop you from getting pregnant, just as your natural hormones would
stop
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Preparatomtale
Page 1 of 17
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Benifema 150 micrograms / 30 micrograms, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 micrograms of desogestrel and 30 micrograms of
ethinylestradiol.
Excipients with known effect: Lactose monohydrate 55 mg, soybean
oil (maximum 0.026 mg).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round film-coated tablets of 5.00 mm diameter. They are marked “C” on one side and “7” on
the reverse side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Benifema should take
into consideration the individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
Benifema compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: oral use.
HOW TO TAKE BENIFEMA
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.
_Paedriatic population _
The safety and efficacy of desogestrel and ethinylestradiol in adolescents below 18 years has not yet
been established. No data are available.
HOW TO START BENIFEMA
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