DESOGESTREL/ETHINYLESTRADIOL ACTAVIS 150/20 Microgram Film Coated Tablet

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

DESOGESTREL MICRONIZED, ETHINYLESTRADIOL MICRONIZED

Tilgjengelig fra:

Actavis Group PTC ehf

ATC-kode:

G03AA09

INN (International Name):

DESOGESTREL MICRONIZED, ETHINYLESTRADIOL MICRONIZED

Dosering :

150/20 Microgram

Legemiddelform:

Film Coated Tablet

Resept typen:

Product subject to prescription which may be renewed (B)

Terapeutisk område:

Progestogens and estrogens, fixed combinations

Autorisasjon status:

Authorised

Autorisasjon dato:

2014-03-28

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER 
DESOGESTREL/ETHINYLESTRADIOL ACTAVIS 150 MICROGRAMS/20 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 Desogestrel/ethinylestradiol Actavis is and
what it is used for 
2. 
What you need to know before you
take Desogestrel/ethinylestradiol Actavis 
3. 
How to take Desogestrel/ethinylestradiol Actavis 
4. 
Possible side effects 
5. 
How to store Desogestrel/ethinylestradiol Actavis 
6. 
Contents of the pack and other information 

1. 
WHAT DESOGESTREL/ETHINYLESTRADIOL ACTAVIS IS AND WHAT IS
USED FOR 

Desogestrel/ethinylestradiol Actavis are
a combined oral contraceptive, also called the pill. 

Each  of  the  21  white  tablets  contains  a  small

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Desogestrel/ethinylestradiol Actavis 150 micrograms /20 micrograms
film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 micrograms of desogestrel and 20
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 with a diameter of 5 mm
approximately. They are coded on one side “C” and on the
reverse side “5”.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Desogestrel/ethinylestradiol Actavis should
take into consideration the individual woman’s
current
risk factors,
particularly those
for
venous
thromboembolism (VTE),
and how the
risk of
VTE with
Desogestrel/ethinylestradiol Actavis 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 Desogestrel/ethinylestradiol Actavis
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.
_Paediatric 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 Desogestrel/ethinylestradiol Actavis
_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