Femilux 3 mg/0,02 mg filmomhulde tabletten

البلد: هولندا

اللغة: الهولندية

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

العنصر النشط:

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

متاح من:

Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)

ATC رمز:

G03AA12

INN (الاسم الدولي):

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

الشكل الصيدلاني:

Filmomhulde tablet

تركيب:

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),

طريقة التعاطي:

Oraal gebruik

المجال العلاجي:

Drospirenone And Ethinylestradiol

ملخص المنتج:

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);

تاريخ الترخيص:

2014-12-30

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FEMILUX 3 MG/0,02 MG FILMOMHULDE TABLETTEN
DROSPIRENONE AND ETHINYLESTRADIOL
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.
WHAT IS IN THIS LEAFLET
1.
What Femilux is and what it is used for
2.
What you need to know before you take Femilux
3.
How to take Femilux
4.
Possible side effects
5.
How to store Femilux
6.
Contents of the pack and other information
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”)
1.
WHAT FEMILUX IS AND WHAT IT IS USED FOR
•
This medicine is a contraceptive pill and is used to prevent
pregnancy.
•
Each of the 24 pink tablets contain 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 FEMILUX
GENERAL NOTES
Before you start using Femilux you should read the information on
blood clots in section 2. It is
particularly important to read the symptoms of a b

خصائص المنتج

1/21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Femilux 3 mg/0,02 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_24 pink film-coated tablets (active tablets): _
Each film-coated tablet contains 3 mg drospirenone and 0.02 mg
ethinylestradiol.
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 anhydrous 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 Femilux should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Femilux
compares with other combined hormonal contraceptives (see sections 4.3
and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE FEMILUX
2/21
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 strip. Tablet taking is continuous. One tablet is
to be taken daily for 28 consecutive
days. Each subsequent strip is started the day after the last tablet
of the previous strip. Withdrawal
bleeding usually starts on day 2-3 after starting the placebo tablets
(last row) and may not have finished
before the next strip is started.
HOW TO START FEMILUX
•
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. on 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 Femilux preferably on the day after the
last active tablet (the last