Vallclara 0,02 mg/3 mg, filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

DROSPIRENON ; ETHINYLESTRADIOL

Available from:

Laboratorios Leon Farma, S.A.

ATC code:

G03AA12

INN (International Name):

DROSPIRENON ; ETHINYLESTRADIOL

Pharmaceutical form:

Filmomhulde tablet

Composition:

CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; 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),

Administration route:

Oraal gebruik

Therapeutic area:

Drospirenone And Ethinylestradiol

Product summary:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); 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);

Authorization date:

2011-09-07

Patient Information leaflet

LF-DRSPEE-NL-NO.H.0193.001.IA.017-D0
1
PACKAGE LEAFLET
LF-DRSPEE-NL-NO.H.0193.001.IA.017-D0
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALLCLARA 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 is and what it is used for
2.
What you need to know before you take Vallclara
3.
How to take Vallclara
4.
Possible side effects
5.
How to store Vallclara
6.
Contents of the pack and other information
1.
1. WHAT VALLCLARA IS AND WHAT IT IS USED FOR
Vallclara is a contraceptive pill and is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones,
namely drospirenone and
ethinylestradiol.
Contraceptive pills that contain two hormones are called
“combination” pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALLCLARA
GENERAL NOTES
LF-DRSPEE-NL-NO.H.0193.001.IA.017-D0
3
Before you start using Vallclara you should read the information on
blood clots in section 2. It is
particularly impo

Summary of Product characteristics

SPC-DRSPEE-NL-NO.H.0193.001.IA.017-D0
SUMMARY OF PRODUCT CHARACTERISTICS
SPC-DRSPEE-NL-NO.H.0193.001.IA.017-D0
1.
NAME OF THE MEDICINAL PRODUCT
Vallclara 0,02 mg/3 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0,02 mg of ethinylestradiol and 3 mg
of drospirenone
Excipient with known effect: Each tablet contains 44 mg lactose
monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round film-coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Vallclara 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 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
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.
HOW TO START VALLCLARA

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)
SPC-DRSPEE-NL-NO.H.0193.001.IA.017-D0
The woman should start with Vallclara preferably on the day after the
last active tablet (the last
tablet containing the active substances) of her previous COC, but at
the latest on the day following
the usual tablet-free or placebo tablet interval of her previous COC.
In case a vaginal ring or
trans