Bellvalyn 150/30 microgram, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DESOGESTREL ; ETHINYLESTRADIOL

Beschikbaar vanaf:

Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)

ATC-code:

G03AA09

INN (Algemene Internationale Benaming):

DESOGESTREL ; ETHINYL ESTRADIOL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; SILICIUMDIOXIDE, GEHYDRATEERD (E 551) ; SOJAOLIE, GEZUIVERD ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171) ; TOCOFEROL, D-ALFA (E 307),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Desogestrel And Ethinylestradiol

Product samenvatting:

Hulpstoffen: GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POLYSORBAAT 80 (E 433); POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); SILICIUMDIOXIDE, GEHYDRATEERD (E 551); SOJAOLIE, GEZUIVERD; STEARINEZUUR (E 570); TITAANDIOXIDE (E 171); TOCOFEROL, D-ALFA (E 307);

Autorisatie datum:

2014-01-27

Bijsluiter

LF-DESOEE-CC-NL.H.2754.002.IB.012-D0
_ _
1
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
BELLVALYN 150/30 MICROGRAM, FILMOMHULDE TABLETTEN
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 your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Bellvalyn is and what it is used for
2.
What you need to know before you take Bellvalyn
3.
How to take Bellvalyn
4.
Possible side effects
5.
How to store Bellvalyn
6.
Contents of the pack and other information
1.
WHAT BELLVALYN IS AND WHAT IS USED FOR
Bellvalyn 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.

The 7 green tablets contain no active substances and are also called
placebo
tablets.
LF-DESOEE-CC-NL.H.2754.002.IB.012-D0
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2
_ _
These help to stop you from getting pregnant, just as your natural
hormones would
stop you conceiving again when you are already pregnant.
The combined contraceptive pill protects you against getting pregnant
in three ways.
These hormones
1. stop the ova

Productkenmerken

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1
_ _
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bellvalyn 150/30 microgram, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
21 WHITE FILM-COATED TABLETS (ACTIVE TABLETS):
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).
7 GREEN PLACEBO (INACTIVE) FILM-COATED TABLETS:
The tablet does not contain active substances
Excipient with known effect: Lactose monohydrate 55 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: White, round film-coated tablets of 5.00 mm diameter.
They are coded on one side
“C” and on the reverse side “7”.
Placebo tablets: Green, round film-coated tablets of 5.00 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Bellvalyn should take into consideration the
individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
Bellvalyn 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 BELLVALYN
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2
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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. Tablet taking is continuous. One
tablet is to be taken daily for 28
consecutive days. Each subsequent pack is started the day after the
last tablet of the previous pack.
Withdrawal bleeding usually starts on day 2-3 after starting the
placebo tablets (last row) 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 BELLVALYN

No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 o