YAZ Film-coated Tablet

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

(Tablet core, Product) Drospirenone; (Tablet core, Product) Ethinylestradiol betadex clathrate

Διαθέσιμο από:

BAYER (SOUTH EAST ASIA) PTE LTD

Φαρμακολογική κατηγορία (ATC):

G03AA12

Δοσολογία:

3.000 mg

Φαρμακοτεχνική μορφή:

TABLET, FILM COATED

Σύνθεση:

(Tablet core, Product) Drospirenone 3.000 mg; (Tablet core, Product) Ethinylestradiol betadex clathrate 0.020 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

BAYER WEIMAR GMBH UND CO. KG

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2008-12-15

Φύλλο οδηγιών χρήσης

YAZ Package Insert

Page 1 of 20 

Yaz PI_SG_CCDS 15 (not inclusive of CCDS 14)_ 4 Aug 2014 

1.  NAME OF THE MEDICINAL PRODUCT 
Yaz 0.02mg/3mg film-coated tablets 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
24 hormone-containing light pink film-coated tablets: 
Each  film-coated  tablet  contains  0.02  mg  ethinylestradiol  (as  betadex  clathrate),  3  mg 
drospirenone. 
4 hormone-free white film-coated tablets.   
For a full list of excipients(s), see section,
“List of excipients”. 

3.  PHARMACEUTICAL FORM 
Film-coated tablet. 

The hormone-containing tablet is light pink, round with
convex faces, one side marked with the 
letters "DS" in a regular hexagon. 

The hormone-free tablet is white, round with convex faces,
one side marked with the letters 
"DP" in a regular hexagon. 

4.  CLINICAL PARTICULARS 
4.1 INDICATIONS 

YAZ  is  indicated  for  the  prevention  of  pregnancy  in  women  who  elect  to  use  an  oral 
contraceptive. 

YAZ is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, 
who have no known contraindications to oral contraceptive therapy and have achieved menarche. 
YAZ should be used for the treatment of acne only if the patient desires an oral contraceptive for 
birth control. 

YAZ is indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in 
women  who  choose  to  use  an  oral  contraceptive  as  their  method  of  contraception.  The 
effectiveness of YAZ for PMDD when used for more than three menstrual cycles has not been 
evaluated.   

4.2 DOSAGE AND METHOD OF ADMINISTRATION 
4.2.1 METHOD OF ADMINISTRATION 
Oral use 
4.2.2 DOSAGE REGIMEN 
HOW TO TAKE YAZ; 24 + 4 FILM-COATED TABLETS 
Combined  oral  contraceptives,  

Αρχείο Π.Χ.Π.

Yaz PI_SG_CCDS 18 (not inclusive of CCDS 14)_ 15 Nov 2016
Page 1 of 21
RESTRICTED
1. NAME OF THE MEDICINAL PRODUCT
Yaz 0.02mg/3mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
24 hormone-containing light pink film-coated tablets:
Each
film-coated
tablet
contains
0.02
mg
ethinylestradiol
(as
betadex
clathrate),
3
mg
drospirenone.
4 hormone-free white film-coated tablets.
For a full list of excipients(s), see section, “List of
excipients”.
3. PHARMACEUTICAL FORM
Film-coated tablet.
The hormone-containing tablet is light pink, round with convex faces,
one side marked with the
letters "DS" in a regular hexagon.
The hormone-free tablet is white, round with convex faces, one side
marked with the letters
"DP" in a regular hexagon.
4. CLINICAL PARTICULARS
4.1 INDICATIONS
YAZ
is
indicated
for the prevention of pregnancy
in women who elect to
use
an oral
contraceptive.
YAZ is indicated for the treatment of moderate acne vulgaris in women
at least 14 years of age,
who
have
no
known
contraindications
to
oral
contraceptive
therapy
and
have
achieved
menarche. YAZ should be used for the treatment of acne only if the
patient desires an oral
contraceptive for birth control.
YAZ is indicated for the treatment of symptoms of premenstrual
dysphoric disorder (PMDD) in
women
who
choose
to
use
an
oral
contraceptive
as
their
method
of
contraception.
The
effectiveness of YAZ for PMDD when used for more than three menstrual
cycles has not been
evaluated.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
4.2.1 METHOD OF ADMINISTRATION
Oral use
4.2.2 DOSAGE REGIMEN
HOW TO TAKE YAZ; 24 + 4 FILM-COATED TABLETS
Combined oral contraceptives, when taken correctly, have a failure
rate of approximately 1%
per year. The failure rate may increase when pills are missed or taken
incorrectly.
Yaz PI_SG_CCDS 18 (not inclusive of CCDS 14)_ 15 Nov 2016
Page 2 of 21
RESTRICTED
Tablets must be taken in the order directed on the package every day
at about the same time
with some liquid as needed. Tablet taking is continuous. One tablet is
to be t