Vallclara 28 0,02 mg/3 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DROSPIRENON ; ETHINYLESTRADIOL

Beschikbaar vanaf:

Laboratorios Leon Farma, S.A.

ATC-code:

G03AA12

INN (Algemene Internationale Benaming):

DROSPIRENON ; ETHINYLESTRADIOL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; 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: CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); LACTOSE 0-WATER; LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL, GEPREGELATINEERD; POLYSORBAAT 80 (E 433); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2011-09-07

Bijsluiter

LF-DRSPEE-NL NO.H.0194.001.IA.019-D0
1
PACKAGE LEAFLET
LF-DRSPEE-NL NO.H.0194.001.IA.019-D0
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALLCLARA 28 0,02 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, pharmacist or
nurse.

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, pharmacist or nurse.
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 Vallclara 28 is and what it is used for
2.
What you need to know before you take Vallclara 28
3.
How to take Vallclara 28
4.
Possible side effects
5.
How to store Vallclara 28
6.
Contents of the pack and other information
LF-DRSPEE-NL NO.H.0194.001.IA.019-D0
3
1.
WHAT VALLCLARA 28 IS AND WHAT IT IS USED FOR

Vallclara 28 is a contraceptive pill and is used to prevent pregnancy.

Each of the 21 pink tablets contains a small amount of two different
female hormones, namely
drospirenone and ethinylestradiol.

The 7 white tablets contain no active substances and are also called
placebo tablets.

Contraceptive pills that contain two hormones are called
“combination” pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALLC

Productkenmerken

SPC-DRSPEE-NL-NO.H.0194.001.IA.018-D0
SUMMARY OF PRODUCT CHARACTERISTICS
SPC-DRSPEE-NL-NO.H.0194.001.IA.018-D0
1.
NAME OF THE MEDICINAL PRODUCT
Vallclara 28 0,02 mg/3 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PINK TABLETS (ACTIVE TABLETS):
Each film-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg
of drospirenone.
Excipient with known effect: Each film-coated tablet contains 44 mg
lactose monohydrate.
WHITE TABLETS (PLACEBO TABLETS):
The tablet does not contain active substances
Excipient with known effect: Each film-coated tablet contains 89.5 mg
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: Pink, round film-coated tablets
Placebo tablets: White, round film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe Vallclara 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 Vallclara 28 compares with other combined hormonal
contraceptives (CHCs) (see
sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE VALLCLARA 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.
HOW TO START VALLCLARA 28
SPC-DRSPEE-NL-NO.H.0194.001.IA.018-D0

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 tr