YAZ PLUS TABLET

Maa: Etelä-Afrikka

Kieli: englanti

Lähde: South African Health Products Regulatory Authority (SAHPRA)

Saatavilla:

Bayer (Pty) Ltd û Isando

Annos:

See ingredients

Lääkemuoto:

TABLET

Koostumus:

EACH TABLET CONTAINS DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,02 mg LEVOMEFOLATE CALCIUM 0,451 mg

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2014-06-03

Pakkausseloste

APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM:
Film-coated tablet
PRODUCT PROPRIETARY NAME:
YAZ PLUS
CCDS10/082016/SA2/02.2022
Page 1 of 11
PATIENT INFORMATION LEAFLET
1
2
3
SCHEDULING STATUS:
S4
4
5
6
YAZ
® PLUS 3MG/0,02 MG/0,451 MG FILM-COATED TABLETS
7
DROSPIRENONE/ETHINYLESTRADIOL (AS BETADEX CLATHRATE)/LEVOMEFOLATE
CALCIUM
8
CONTAINS SUGAR (LACTOSE)
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10
Read all of this leaflet carefully before you start taking YAZ PLUS.
11
•
Keep this leaflet. You may need to read it again.
12
•
If you have further questions, please ask your doctor or your
pharmacist.
13
•
YAZ PLUS has been prescribed for you personally and you should not
share your medicine with
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other people. It may harm them, even if their symptoms are the same as
yours.
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WHAT IS IN THIS LEAFLET
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1 WHAT YAZ PLUS IS AND WHAT IT IS USED FOR
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2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE YAZ PLUS
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3 HOW TO TAKE YAZ PLUS
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4 POSSIBLE SIDE EFFECTS
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5 HOW TO STORE YAZ PLUS
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6 CONTENTS OF THE PACK AND OTHER INFORMATION
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25
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1.
WHAT YAZ PLUS IS WHAT IT IS USED FOR
27
28
•
YAZ PLUS is used to prevent pregnancy and to improve the folate status
in women who decide to
29
use oral contraception.
30
•
YAZ
PLUS
is
used
for
the
treatment
of
moderate
acne
vulgaris
in
women
seeking
oral
31
contraception.
32
•
YAZ PLUS is also used for the treatment of symptoms of premenstrual
dysphoric disorder
33
(PMDD) in women who have chosen oral contraceptive as their method of
birth control. The
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efficacy of YAZ PLUS for PMDD was not assessed beyond 3 cycles.
35
36
Each of the 24 pink film-coated tablets contains a small amount of the
female hormones
37
ethinylestradiol and drospirenone and the vitamin levomefolate calcium
(which is also contained
38
in the 4 light orange hormone-free film-coated tablets).
39
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Contraceptive pills that contain two hormones are called ‘combined
pills’ or ‘combined oral
41
contraceptives’.
42
43
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2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE YAZ PLUS
45
46
GENERAL NOTES
47
48
In this leaflet, several situations a

Valmisteyhteenveto

APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM:
Film-coated tablet
PRODUCT PROPRIETARY NAME:
YAZ PLUS
CCDS10/08.2016/SA2/02.2022
Page
1
of
15
SCHEDULING STATUS:
S4
1.
NAME OF THE MEDICINE
YAZ
®
PLUS 3mg/0,02 mg/0,451 mg film-coated tablets
2.
QUALITATIVE AND QUANTITAIVE COMPOSITION
24 hormone-containing pink film-coated tablets:
Each film-coated tablet contains 3 mg drospirenone, 0,020 mg
ethinylestradiol (as betadex clathrate)
and 0,451 mg levomefolate calcium (equimolar to 0,400 mg folic acid)
Contains 45 mg lactose
4 hormone-free light orange film-coated tablets:
Each film-coated tablet contains 0,451 mg levomefolate calcium.
Contains 48 mg lactose
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
The hormone-containing tablet is pink, round with convex faces, one
side marked with “Z+” in a
regular hexagon, while the other side is blank.
The hormone-free tablet is light orange, round with convex faces, one
side marked with “M+” in a
regular hexagon, while the other side is blank.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
•
Oral contraception.
•
Improvement in folate status in women who elect to use oral
contraception.
•
Treatment of moderate acne vulgaris in women seeking oral
contraception.
•
Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in
women who have
chosen oral contraception as their method of birth control. The
efficacy of YAZ PLUS for
PMDD was not assessed beyond 3 cycles. YAZ PLUS has not been evaluated
for treatment of
premenstrual syndrome (PMS).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_How to take YAZ PLUS _
YAZ PLUS, when taken correctly, has a failure rate of approximately 1
% per year. The failure rate
may increase when pills are missed or taken incorrectly.
_ _
Tablets must be taken in the order directed on the package, at about
the same time every day, with
some liquid if needed. Tablet taking is continuous. One tablet is
taken daily for 28 consecutive days.
_ _
The first course of YAZ PLUS is star