YASMIN PLUS TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Bayer (Pty) Ltd û Isando

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS DROSPIRENONE 3,0 mg ETHINYLESTRADIOL 0,03 mg LEVOMEFOLATE CALCIUM 0,451 mg

Authorization status:

Registered

Authorization date:

2013-10-10

Patient Information leaflet

APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM:
Film-coated tablet
PRODUCT PROPRIETARY NAME:
YASMIN PLUS
CCDS10/08.2016/SA2/02.2022
Page
1
of
12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
S4
YASMIN
® PLUS 3MG/0,03 MG/0,451 MG FILM-COATED TABLETS
DROSPIRENONE/ETHINYLESTRADIOL (AS BETADEX CLATHRATE)/LEVOMEFOLATE
CALCIUM
CONTAINS SUGAR (LACTOSE)
_ _
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YASMIN
PLUS.
Keep this leaflet. You may need to read it again.
If you have further questions, please ask your doctor or your
pharmacist.
YASMIN PLUS has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
_ _
_ _
WHAT IS IN THIS LEAFLET
1 WHAT YASMIN PLUS IS AND WHAT IT IS USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE YASMIN PLUS
3 HOW TO TAKE YASMIN PLUS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE YASMIN PLUS
6 CONTENTS OF THE PACK AND OTHER INFORMATION
_ _
_ _
1.
WHAT YASMIN PLUS IS WHAT IT IS USED FOR
YASMIN PLUS is a contraceptive pill and it is used to prevent
pregnancy and to improve the folate
status in women who decide to use oral contraception.
Each
of
the
21
orange
film-coated
tablets
contains
a
small
amount
of
the
female
hormones
ethinylestradiol and drospirenone and levomefolate calcium (which is
also contained in the 7 light
orange hormone-free film-coated tablets).
Contraceptive
pills
that
contain
two
hormones
are
called
“combined
pills”
or
“combined
oral
contraceptives”.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE YASMIN PLUS
GENERAL NOTES
In this leaflet, several situations are described where you should
stop using YASMIN PLUS, or where
the reliability of YASMIN PLUS may be decreased. In such situations
you should either not have
sexual intercourse or you should take extra non-hormonal contraceptive
precautions, e.g. use a
condom or another barrier method. Do not use rhythm or temperature
methods. These methods can be
unreliable because YASMIN PLUS alters the monthly changes of body
te

Summary of Product characteristics

APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM:
Film-coated tablet
PRODUCT PROPRIETARY NAME:
YASMIN PLUS
CCDS9/08.2016/SA2/02.2022
Page
1
of
16
SCHEDULING STATUS:
S4
1.
NAME OF THE MEDICINE
YASMIN
®
PLUS 3mg/0,03 mg/0,451 mg film-coated tablets
2.
QUALITATIVE AND QUANTITAIVE COMPOSITION
21 hormone-containing orange film-coated tablets:
Each film-coated tablet contains 3 mg drospirenone, 0,030 mg
ethinylestradiol (as betadex clathrate)
and 0,451 mg levomefolate calcium (equimolar to 0,400 mg folic acid)
Contains 45 mg lactose
7 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 orange, round with convex faces, one
side marked with “Y+” 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, and
•
Improvement in folate status in women who elect to use oral
contraception.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
YASMIN 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 YASMIN PLUS is started on the first day of the
menstrual period (day 1 of the
cycle) from the silver section of the pack by selecting the
appropriate tablet for that day of the week
(e.g. “MO” for Monday). The tablet is swallowed whole with some
liquid. Thereafter one tablet must
be taken daily for 28 days following the direction shown by the
arrows. It does not matter at what time
APPLICAN