Drospirenon/Ethinylestradiol 3/0,02 mg 24+4 Theramex, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

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

Beschikbaar vanaf:

Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock D01 YE64 DUBLIN 1 (IERLAND)

ATC-code:

G03AA12

INN (Algemene Internationale Benaming):

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

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), 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:

2013-04-25

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DROSPIRENON/ETHINYLESTRADIOL 3/0,02 MG 24+4 THERAMEX, FILMOMHULDE
TABLETTEN
Ethinylestradiol/Drospirenone
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,
even if their signs of illness are the same as yours.

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.
WHAT IS IN THIS LEAFLET
1.
What is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR

is a contraceptive pill and is used to prevent
pregnancy.

Each of the 24 pink tablets contains a small amount of two different
female hormones,
namely drospirenone and ethinylestradiol.

The 4 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
GENERAL NOTES
Before you start using you should read the information
on bloo

Productkenmerken

1/24
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Drospirenon/Ethinylestradiol 3/0,02 mg 24+4 Theramex, filmomhulde
tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
24 pink film-coated tablets (active tablets):
Each film-coated tablet contains 0.02 mg ethinylestradiol and 3 mg
drospirenone.
Excipient with known effect: Lactose monohydrate 44 mg
4 white placebo (inactive) film-coated tablets:
The tablet does not contain active substances
Excipient with known effect: Lactose 89.5 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
The active tablet is pink, round film-coated tablet of 5.7 mm
diameter.
The placebo tablet is white, round film-coated tablet of 5.7 mm
diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe should take into
consideration the individual woman’s current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
2/24
_How to take _
The tablets must be taken every day at about the same time, if
necessary with a little liquid, in the order
shown on blister. Tablet taking is continuous. One tablet is to be
taken daily for 28 consecutive days.
Each subsequent blister is started the day after the last tablet of
the previous blister. Withdrawal bleeding
usually starts on day 2-3 after starting the placebo tablets (last
row) and may not have finished before the
next blister is started.
_How to start _

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)
The woman should start with preferably on the day
after the