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

Country: Olanda

Lingwa: Olandiż

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

Ingredjent attiv:

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

Disponibbli minn:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

Kodiċi ATC:

G03AA12

INN (Isem Internazzjonali):

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

Għamla farmaċewtika:

Filmomhulde tablet

Kompożizzjoni:

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),

Rotta amministrattiva:

Oraal gebruik

Żona terapewtika:

Drospirenone And Ethinylestradiol

Sommarju tal-prodott:

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);

Data ta 'l-awtorizzazzjoni:

2013-04-25

Fuljett ta 'informazzjoni

Approved NL/H/2352/001/IA/010 IAIN C.I.z 23 February 2019; approved
with
NL/H/2352/001/IB/012 IB C.I.3.z; approved with NL/H/2352/001/IB/014 IB
C.I.3.z on 16
December 2021; proposed with NL/H/2352/001/IA/017 IAIN C.I.3.a
PACKAGE LEAFLET: INFORMATION FOR THE USER
DROSPIRENON/ETHINYLESTRADIOL 3/0,02 MG 24+4 DOC GENERICI, FILMOMHULDE
TABLETTEN
DROSPIRENON/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.
•
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 DROSPIRENON/ETHINYLESTRADIOL DOC GENERICI IS AND WHAT IT IS USED
FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DROSPIRENON/ETHINYLESTRADIOL DOC
GENERICI
When you should not use Drospirenon/Ethinylestradiol DOC Generici
Warnings and precautions
Blood clots
Drospirenon/Ethinylestradiol DOC Generici and cancer
Bleeding between periods
What you must do if no bleeding occurs during the placebo days
Other medicines and Drospirenon/Ethinylestradiol DOC Generici
Drospirenon/Ethinylestradiol DOC Generici with food and drink
Laboratory tests
Pregnancy
Breast-feeding
Driving and using machines
Drospirenon/Ethinylestradiol DOC Generici contains lactose
3.

Karatteristiċi tal-prodott

Approved with NL/H/2352/001/IA/010 IAIN C.I.z 23 February 2019 (PRAC
– Suicidality),
approved with NL/H/2352/001/IB/012 IB C.I.3.z; approved with
NL/H/2352/001/IB/014 IB
C.I.3.z on 16 december 2021; proposed with NL/H/2352/001/IA/017 IAIN
C.I.3.a
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Drospirenon/Ethinylestradiol DOC Generici 0.02 mg / 3 mg film-coated
tablets
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 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 Drospirenon/Ethinylestradiol DOC Generici
should take into consideration
the individual woman’s current risk factors, particularly those for
venous thromboembolism (VTE),
and how the risk of VTE with Drospirenon/Ethinylestradiol DOC Generici
compares with other
Combined Hormonal Contraceptives (CHCs) (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
HOW TO TAKE DROSPIRENON/ETHINYLESTRADIOL DOC GENERICI
Approved with NL/H/2352/001/IA/010 IAIN C.I.z 23 February 2019 (PRAC
– Suicidality),
approved with NL/H/2352/001/IB/012 IB C.I.3.z; approved with
NL/H/2352/001/IB/014 IB
C.I.3.z on 16 december 2021; proposed with NL/H/2352/001/IA/017 IAIN
C.I.3.a
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