Carmenelle 0,02 mg/3 mg filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

DROSPIRENON 3 mg/stuk ; ETHINYLESTRADIOL 0,02 mg/stuk

Available from:

Laboratorios Leon Farma, S.A. C/ La Vallina s/n. P.I Navatejera 24008 NAVATEJERA (LEON) (SPANJE)

ATC code:

G03AA12

INN (International Name):

DROSPIRENON 3 mg/stuk ; ETHINYLESTRADIOL 0,02 mg/stuk

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:

2013-10-09

Patient Information leaflet

LF-DRSP/EE-NL-NL.H.2631.001.IA.020-D0
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CARMENELLE 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 no 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 CARMENELLE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARMENELLE
•
When you should not use Carmenelle
•
Warnings and precautions
•
Carmenelle and venous and arterial blood clots
•
Carmenelle and cancer
•
Bleeding between periods
•
What to do if no bleeding occurs during the gap week
•
Other medicines and Carmenelle
•
Taking Carmenelle with food, drink and alcohol
•
Laboratory tests
•
Pregnancy, breast-feeding and fertility
•
Driving and using machines
•
Carmenelle contains lactose
3.
HOW TO TAKE CARMENELLE
•
When can you start with the first strip?
•
If you take more Carmenelle than you should
•
If you forget to take Carmenelle
•
What to do in the case of vomiting or severe diarrhoea
•
Delaying your period: what you need to know
�

Summary of Product characteristics

SPC-DRSP/EE-NL-NL.H.2631.001.IA.020-D0
1/20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Carmenelle 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
Excipients with known effect:
Lactose monohydrate 44 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round film-coated tablets of 5.7 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Carmenelle should take into consideration
the individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
Carmenelle compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: oral use.
POSOLOGY
HOW TO TAKE CARMENELLE
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 CARMENELLE
•
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-DRSP/EE-NL-NL.H.2631.001.IA.020-D0
2/20
The woman should start with Carmenelle 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
transdermal patch has be