FEMODENE ED 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 ETHINYLESTRADIOL 0,030 mg GESTODENE 0,75 mg

Authorization status:

Registered

Authorization date:

1990-03-09

Patient Information leaflet

APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM: C
oated tablet
PRODUCT PROPRIETARY NAME:
FEMODENE ED
CCPI14/09.2016/SA3/02.2022
Page
1
of
12
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S3
FEMODENE
® ED 0,03 MG/0,075 MG COATED TABLETS
ETHINYLESTRADIOL/GESTODENE
CONTAINS SUGAR (LACTOSE AND SUCROSE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING FEMODENE ED
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or pharmacist.
•
FEMODENE ED has been prescribed for you personally and you should not
share you r medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
WHAT IS IN THIS LEAFLET
1.
What FEMODENE ED is and what it is used for
2.
What you need to know before you take FEMODENE ED
3.
How to take FEMODENE ED
4.
Possible side effects
5.
How to store FEMODENE ED
6.
Contents of the pack and other information
1.
WHAT FEMODENE ED IS AND WHAT IT IS USED FOR
FEMODENE ED is a combined oral contraceptive pill and is used to
prevent pregnancy.
Each of the 21 smaller white coated tablets contains a small amount of
the female hormones
ethinylestradiol and gestodene.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMODENE ED
GENERAL NOTES
Before you can begin taking FEMODENE ED, your doctor will ask you some
questions about your
personal health history and that of your close relatives. The doctor
will also measure your blood pressure
and, depending upon your personal situation, may also carry out some
other tests.
In this leaflet, several situations are described where you should
stop using FEMODENE ED, or where
the reliability of FEMODENE ED may be decreased. In such situations
you should either not have sex 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
FEMODENE ED alters the monthly changes of body temperature and
cervical mucus.
FEMODENE ED, LIKE OTHER HORMONAL CONTRACEPTIVES, DOES NOT

Summary of Product characteristics

APPLICANT/PHRC:
Bayer (Pty) Ltd
DOSAGE FORM:
Coated tablet
PRODUCT PROPRIETARY NAME:
FEMODENE ED
CCDS14/09.2016/SA3/05.2022
Page
1
of
12
SCHEDULING STATUS
S3
1.
NAME OF THE MEDICINE
FEMODENE
® ED
0,03 mg/0,075 mg coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The 28-day pack (Every-Day pack) contains:
21 hormone-containing small white tablets:
Each coated tablet contains ethinylestradiol 0,03 mg and gestodene
0,075 mg.
Contains sugar (lactose – 36 mg and sucrose – 20 mg)
7 hormone-free large white coated tablets.
Contains sugar (lactose –46 mg and sucrose – 34 mg)
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablets.
The hormone-containing tablets are small, white, round with convex
faces.
The hormone-free tablets are larger, white, round with convex faces.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Oral contraception.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_How to take FEMODENE ED _
The first course of FEMODENE ED 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 of the day
the tablet is taken, but once the patient has selected a particular
time, the tablet should be taken as near as
possible at the same time each day. Withdrawal bleeding usually starts
on day 2 to 3 after starting the
hormone-free larger white tablets and may not have finished before the
next pack is started. Each
subsequent pack is started the day after the last tablet of the
current pack. If a patient starts FEMODENE
ED during the latter part of the week, the very first cycle may be
slightly shortened.
_How to start FEMODENE ED _
•
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman’s natural