Armarrok 28, filmomhulde tabletten 0,03 mg/3 mg

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DROSPIRENON ; ETHINYLESTRADIOL

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

G03AA12

INN (Algemene Internationale Benaming):

DROSPIRENON ; ETHINYLESTRADIOL

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:

2011-09-14

Bijsluiter

Sandoz B.V.
Page 1/17
Armarrok 28 filmomhulde tabletten 0.03 mg/3 mg
RVG 107872
1311-V10
1.3.1.1 Package Leaflet
Mei 2021
PACKAGE LEAFLET: INFORMATION FOR THE USER
Armarrok 28, filmomhulde tabletten 0.03 mg / 3 mg
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 [nationally completed name] is and what it is used for
2.
What you need to know before you take
[nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[nationally completed name] is a contraceptive pill and is used to
prevent pregnancy.
Each of the 21 yellow 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 [NATIONALLY

Productkenmerken

Sandoz B.V.
Page 1/22
Armarrok 28 filmomhulde tabletten 0.03 mg/3 mg
RVG 107872
20210528
1.3.1.1 Summary of Product Characteristics
Mei 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Armarrok 28 filmomhulde tabletten 0.03 mg/3 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
YELLOW TABLETS (ACTIVE TABLETS):
Each film-coated tablet contains 0.03mg of ethinylestradiol and 3 mg
of drospirenone
Excipient with known effect
Each film-coated tablet contains 62 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, anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Active tablets: Yellow, round film-coated tablets
Placebo tablets: White, round film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe [nationally completed name] should take into
consideration the individual
woman’s current risk factors, particularly those for venous
thromboembolism (VTE), and how the
Sandoz B.V.
Page 2/22
Armarrok 28 filmomhulde tabletten 0.03 mg/3 mg
RVG 107872
20210528
1.3.1.1 Summary of Product Characteristics
Mei 2021
risk of VTE with [nationally completed name] compares with other CHCs
(see sections 4.3 and
4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
HOW TO TAKE [NATIONALLY COMPLETED NAME]
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 [NATIONALLY COMPLETED NAME]
•
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to s