Bryorlene 0,10 mg/0,02 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ETHINYLESTRADIOL ; LEVONORGESTREL

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

G03AA07

INN (Algemene Internationale Benaming):

ETHINYL ESTRADIOL ; LEVONORGESTREL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

ALLURAROOD AC ALUMINIUM LAK (E 129) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 0-WATER ; LECITHINE, SOYA (E 322) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Levonorgestrel And Ethinylestradiol

Product samenvatting:

Hulpstoffen: ALLURAROOD AC ALUMINIUM LAK (E 129); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 0-WATER; LECITHINE, SOYA (E 322); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2014-01-22

Bijsluiter

Sandoz B.V.
Page 1/15
Bryorlene 0,10 mg/0,02 mg, filmomhulde tabletten
RVG 112767
1313-v9
1.3.1.3 Bijsluiter
Maart 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRYORLENE 0,10 MG/0,02 MG, FILMOMHULDE TABLETTEN
levonorgestrel / ethinylestradiol
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,
even if their signs of illness are the same as yours.
•
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 [nationally completed name]
is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
•
[nationally completed name] is a contraceptive pill and it is used to
prevent pregnancy.
•
Each tablet contains a small amount of two different female hormones,
namely levonorgestrel and
ethinylestradiol.
•
Contraceptive
pills
that
contain
two
hormones
are
called
‘combination
pills.’
[nationally
completed name] is called a “low-dose” contraceptive pill because
it contains only a small amount
of hormones.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
GENERAL NOTES
Before you start using [nationally completed name] you should read the
information on blood
clots in section 2. It is particularly important to read the symptoms
of a blood clot – see section 2
‘BLOOD CLOTS’.
Before you can begin taking [nationally completed name], your doctor
will ask you some
questions about your personal health history and that of your

Productkenmerken

Sandoz BV
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Bryorlene 0,10 mg/0,02 mg, filmomhulde tabletten
1311-V6
RVG 112767
1.3.1.1. Samenvatting van de productkenmerken
Maart 2020
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bryorlene 0,10 mg/0,02 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.10 mg levonorgestrel and 0.02 mg
ethinylestradiol
Excipient(s) with known effect
Each tablet contains 89.38 mg of lactose (as anhydrous), up to 4 mg of
Red aluminium lake
(E129) and up to 4 mg of soya lecithin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Tablets are pink and rounded with a diameter of 6 mm approx.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe [nationally completed name] should take into
consideration the
individual woman’s current risk factors, particularly those for
venous thromboembolism (VTE),
and how the risk of VTE with [nationally completed name] compares with
other combined
hormonal contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO USE [NATIONALLY COMPLETED NAME] TABLETS
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.
Sandoz BV
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Bryorlene 0,10 mg/0,02 mg, filmomhulde tabletten
1311-V6
RVG 112767
1.3.1.1. Samenvatting van de productkenmerken
Maart 2020
HOW TO START [NATIONALLY COMPLETED NAME] TABLETS
•
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 days 2-5 is allowed but in th