BENIFEMA 150/30 Microgram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DESOGESTREL, ETHINYLESTRADIOL

Available from:

Actavis Group PTC ehf

ATC code:

G03AA09

INN (International Name):

DESOGESTREL, ETHINYLESTRADIOL

Dosage:

150/30 Microgram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Progestogens and estrogens, fixed combinations

Authorization status:

Authorised

Authorization date:

2013-11-29

Patient Information leaflet

 
1 

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. See section 4. 

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 

Summary of Product characteristics

SUMMARY OF 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 the 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
_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). Starting
on day 2-5 is allowed,
but during the first cycle a barrier method is recommended in addition
for the first 7 days of
tablet-taking.
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