Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ETHINYLESTRADIOL ; LEVONORGESTREL

Beschikbaar vanaf:

Laboratoires Chemical Farma

ATC-code:

G03AA07

INN (Algemene Internationale Benaming):

ETHINYL ESTRADIOL ; LEVONORGESTREL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Levonorgestrel And Ethinylestradiol

Product samenvatting:

Hulpstoffen: CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2013-10-24

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVONORGESTREL/ETHINYLESTRADIOL CHEMICAL FARMA 150/30 MICROGRAM,
FILMOMHULDE TABLETTEN
Levonorgestrel / Ethinylestradiol
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 Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram,
filmomhulde tabletten is and
what it is used for
2.
What you need to know before you take Levonorgestrel/Ethinylestradiol
Chemical Farma 150/30
microgram, filmomhulde tabletten
3.
How to take Levonorgestrel/Ethinylestradiol Chemical Farma 150/30
microgram, filmomhulde tabletten
4.
Possible side effects
5.
How to store Levonorgestrel/Ethinylestradiol Chemical Farma 150/30
microgram, filmomhulde tabletten
6.
Contents of the pack and other information
1.
WHAT LEVONORGESTREL/ETHINYLESTRADIOL CHEMICAL FARMA 150/30 MICROGRAM,
FILMOMHULDE TABLETTEN IS
AND WHAT IT IS USED FOR

Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram,
filmomhulde tabletten is a
contraceptive pill and it is used to prevent pregnancy.
•
Each of the 21 yellow tablets contains a small amount of two different
female hormones, namely
levonorgestrel 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 LEVONORGESTREL/ETHINYLESTRADIOL
CHEMICAL FARMA 150/30
MICROGRAM, FILMOMHULDE TABLETTEN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
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Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levonorgestrel/Ethinylestradiol Chemical Farma 150/30 microgram,
filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
21 YELLOW FILM-COATED TABLETS (ACTIVE TABLETS):
0.15 mg levonorgestrel and 0.03 mg ethinylestradiol
Excipients with known effect:Each tablet contains 84.32 mg of lactose
monohydrate
7 WHITE PLACEBO (INACTIVE) FILM-COATED TABLETS:
The tablet do not contain active substances
Excipients with known effect: Each tablet contains 89.50 mg of lactose
anhydrous
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Active tablet: Yellow, round, with a diameter of 6 mm and thickness
less than 4 mm approximately.
Placebo tablet: White, round, with a diameter of 6 mm and thickness of
3 - 4 mm approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral Contraception.
The decision to prescribe Levonorgestrel/Ethinylestradiol Chemical
Farma 150/30 microgram should
take into consideration the individual woman's current risk factors,
particularly those for venous
thromboembolism (VTE), and how the risk of VTE with
Levonorgestrel/Ethinylestradiol Chemical
Farma 150/30 microgram compares with other combined hormonal
contraceptives (CHCs) (see sections
4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration_
Oral use
_Posology_
How to take Levonorgestrel/Ethinylestradiol Chemical Farma 150/30
microgram
The tablets must be taken every day at about the same time, if
necessary with a little in the order
shown on the blister pack. One tablet is to be taken daily for 28
consecutive days. Each subsequent pack
is started
after a 7-day placebo-tablet-intake interval, during which time a
withdrawal bleed usually
occurs. This usually starts on day 2-3 after the last active tablet
and may not have finished before
the next pack is started.
How to start Levonorgestrel/Ethinylestradiol Chemical Farma 150/30
microgram

No preceding hormonal contraceptive use [in the past mon