Feminegi 3 mg/0,03 mg filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

DROSPIRENON 3 mg/stuk ; ETHINYLESTRADIOL 0,03 mg/stuk

Available from:

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

ATC code:

G03AA12

INN (International Name):

DROSPIRENON 3 mg/stuk ; ETHINYLESTRADIOL 0,03 mg/stuk

Pharmaceutical form:

Filmomhulde tablet

Composition:

CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; 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),

Administration route:

Oraal gebruik

Therapeutic area:

Drospirenone And Ethinylestradiol

Product summary:

Hulpstoffen: CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); 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);

Authorization date:

2014-03-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
FEMINEGI 3 MG/ 0,03 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 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 FEMINEGI IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMINEGI
3.
HOW TO TAKE FEMINEGI
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE FEMINEGI
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 FEMINEGI IS AND WHAT IT IS USED FOR
•
This medicine is a contraceptive pill and is used to prevent
pregnancy.
•
Each tablet contains a small amount of two different female hormones,
namely
drospirenone and ethinylestradiol.
•
Contraceptive pills that contain two hormones are called
“combination” pills.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMINEGI
GENERAL NOTES
Before you start using Feminegi you should read the information on
blood clots in section 2. It is
particularly important to read the symptoms of a blood clot – see
section 2 “Blood clots”.
2
Before you can begin taking this medicine, your doctor will ask

Summary of Product characteristics

1/19
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Feminegi 3 mg/ 0,03 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 3 mg of drospirenone and 0.03 mg of
ethinylestradiol
Excipient with known effect
Lactose monohydrate 62 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow round film-coated tablets of 5.7 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Feminegi should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Feminegi
compares with other combined hormonal contraceptives (see sections 4.3
and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE FEMINEGI
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 FEMINEGI
•
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).
2/19
•
Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC),
vaginal ring, or transdermal patch)
The woman should start with Feminegi
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
been used, the woman should start using Feminegi
_ _
preferably on the day of removal, but at the