Bellverene 28 0,03 mg/3 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DROSPIRENON 3 mg/stuk ; ETHINYLESTRADIOL 0,03 mg/stuk

Beschikbaar vanaf:

Exeltis Healthcare S.L Avenue Miralcampo 7, Poligono Ind. Miralcampo 19200 AZUQUECA DE HENARES (SPANJE)

ATC-code:

G03AA12

INN (Algemene Internationale Benaming):

DROSPIRENON 3 mg/stuk ; ETHINYLESTRADIOL 0,03 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; POLYSORBAAT 80 (E 433) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Drospirenone And Ethinylestradiol

Product samenvatting:

Hulpstoffen: CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); LACTOSE 0-WATER; LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; POLYSORBAAT 80 (E 433); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2013-08-01

Bijsluiter

LF-CC-DRSP/EE-NL.H.2632.002.IB.020-D0
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BELLVERENE 28 0,03 MG/3 MG FILMOMHULDE TABLETTEN
ETHINYLESTRADIOL/DROSPIRENONE
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 no 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.
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
”
)
WHAT IS IN THIS LEAFLET
:
1.
What Bellverene 28 is and what it is used for
2.
What you need to know before you take Bellverene 28
When you should not use Bellverene 28
Warnings and precautions
BLOOD CLOTS
Bellverene 28 and cancer
Psychiatric disorders
Bleeding between periods
What to do if no bleeding occurs during the gap week
Other medicines and Bellverene 28
Bellverene 28 with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
Bellverene 28 contains lactose
3.
How to take Bellverene 28
When can you start with the first strip?
If you take more Bellverene 28 than you should
If you forget to take Bellverene 28
What to do in the case of vomiting or severe diarrhoea
LF-CC-DRSP/EE-NL.H.2632.002.IB.020-D0
2
Delaying your period: what you need to know
Changing the first day of your period: what you need to know
If you stop taking Bellverene 28
4.
Possib

Productkenmerken

SPC-CC-DRSP/EE-NL.H.2632.002.IB.020-D0
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bellverene 28 0,03 mg/3 mg filmomhulde tabletten>
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
YELLOW TABLETS (ACTIVE TABLETS):
Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg
of drospirenone
Excipients with known effects:
Lactose monohydrate 62 mg
WHITE TABLETS (PLACEBO TABLETS)
The tablet does not contain active substances
Excipients with known effects:
Lactose, 89.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: Yellow, round film-coated tablets of 5.7 mm diameter.
Placebo tablets: White, round film-coated tablets of 5.7 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Bellverene 28 should take into consideration
the individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
Bellverene 28 compares with other combined hormonal contraceptives
(see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_METHODOF ADMINISTRATION_
:
Oral use.
_POSOLOGY _
HOW TO TAKE BELLVERENE 28
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.
SPC-CC-DRSP/EE-NL.H.2632.002.IB.020-D0
2
HOW TO START BELLVERENE 28
•
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).
•
Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC),
vaginal ring, or transdermal patch)