Talia 0,02 mg/3 mg filmomhulde tabletten

Country: Netherlands

Language: Dutch

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

Active ingredient:

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

Available from:

Exeltis Healthcare S.L Avenue Miralcampo 7, Poligono Ind. Miralcampo 19200 AZUQUECA DE HENARES (SPANJE)

ATC code:

G03AA12

INN (International Name):

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

Pharmaceutical form:

Filmomhulde tablet

Composition:

CROSCARMELLOSE NATRIUM (E 468) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; 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),

Administration route:

Oraal gebruik

Therapeutic area:

Drospirenone And Ethinylestradiol

Product summary:

Hulpstoffen: CROSCARMELLOSE NATRIUM (E 468); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); 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);

Authorization date:

2014-05-21

Patient Information leaflet

Talia Package Leaflet
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TALIA 0.02 MG/3 MG FILM-COATED TABLETS
Ethinylestradiol/Drospirenone
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 Talia is and what it is used for
2.
What you need to know before you take Talia
3.
How to take Talia
4.
Possible side effects
5.
How to store Talia
6.
Contents of the pack and other information
1.
WHAT TALIAIS AND WHAT IT IS USED FOR
•
Talia is a contraceptive pill and is used to prevent pregnancy.
•
Each of the 24 tablets 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 TAKETALIA
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE 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.
BEFORE YOU START USING TALIA FOR THE FIRST TIME YOU SHOULD DISCUSS
WITH YOUR DOCTOR HOW TO
USE THIS
PRODUCT.
Before you start using Talia you should read the information on blood
clots in section 2. It is particularly
important to read the symptoms of a blood clot – see se

Summary of Product characteristics

Talia SmPC
1
SUMMARY OF PRODUCT CHARACTERISTICS
TALIA 0.02 MG/3 MG FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Talia 0.02 mg/3 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 0.02 mg ethinylestradiol and 3 mg
drospirenone.
Excipient with known effect: lactose 44 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
The tablet is a pink and round film-coated of 5.7 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
The decision to prescribe [invented name] should take into
consideration the individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with [invented
name] compares with other CHCs (see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION:
oral use
POSOLOGY
The tablets must be taken every day at about the same time, if
necessary with a small amount of liquid.
Tablets must always be taken without interruption for a minimum of 24
days.Talia can be taken without
interruption for up to 120 days, after which a 4-day tablet-free
interval must be started.
THE TABLET TAKING CONSIST OF TWO PHASES:
1.
Mandatory phase (day 1-24)
When starting Talia tablets must be taken without interruption for a
minimum of 24 days, after which the
woman can either:
- take a 4-day tablet-free interval
- or continue to take the tablets for up to 120 days (see flexible
phase below).
2.
Flexible phase (day 25-120)
During the days 25-120, the tablets can be taken without interruption
up to a maximum of 120 days. During
this period, the woman may decide herself to take the 4-day
tablet-free interval (to induce withdrawal
bleeding). This 4-day free-tablet-interval should only be started if
tablet taking has been uninterrupted for a
period of 24 days.
Talia SmPC
2
Talia SmPC
3
In the event of continued bleeding (three consecutive days) during the
flexible phase (days 25-120), it is
advisable to take the 4-