MINULETTE TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pfizer Laboratories (Pty) Ltd

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

Pfizer Laboratories (Pty) Ltd
Page 1 of 13
Minulette 75/30 micrograms film-coated tablets
Final Approved PIL: 04 October 2021
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S3
MINULETTE

, 75/30 MICROGRAMS FILM-COATED TABLETS
GESTODENE AND ETHINYLESTRADIOL
CONTAINS SUGAR
EACH MINULETTE 75 ΜG/30 ΜG ACTIVE TABLET CONTAINS 37,43 MG LACTOSE
MONOHYDRATE AND 19,661
MG SUCROSE.
EACH INACTIVE (PLACEBO) TABLET CONTAINS 33,15 MG LACTOSE MONOHYDRATE
AND 17,879 MG SUCROSE.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING MINULETTE
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
MINULETTE 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 MINULETTE is and what it is used for
2. What you need to know before you take MINULETTE
3. How to take MINULETTE
4. Possible side effects
5. How to store MINULETTE
6. Contents of the pack and other information
1. WHAT MINULETTE IS AND WHAT IT IS USED FOR
MINULETTE is a combined hormonal oral contraceptive often referred to
as the ‘Pill’ and is used for the
prevention of pregnancy.
Pfizer Laboratories (Pty) Ltd
Page 2 of 13
Minulette 75/30 micrograms film-coated tablets
Final Approved PIL: 04 October 2021
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MINULETTE
DO NOT TAKE MINULETTE:
•
if you are hypersensitive (allergic) to gestodene, ethinylestradiol or
to any of the other ingredients of
MINULETTE (listed in section 6)
•
if you have blood clots or a history of blood clots in your legs (deep
vein thrombosis [DVT]), your
lungs (pulmonary embolism), your eyes or other organs
•
if you have ever had a heart attack or stroke
•
if you have heart disease including heart valve disorders or certain
heart rhythm disorders
•
if you have an inherited or acquired disorder that affects your blood
clotting
•
if you get headach

Summary of Product characteristics

Pfizer Laboratories (Pty) Ltd
Page 1 of 24
Minulette 75/30 micrograms film-coated tablets
Final Approved PI: 04 October 2021
SCHEDULING STATUS: S3
1. NAME OF THE MEDICINE
MINULETTE
®
, 75/30 micrograms film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white active tablet contains gestodene 75
µ
g and ethinylestradiol 30
µ
g (21 tablets). The 7 red
tablets are placebo and do not contain any active ingredients.
Contains sugar (lactose monohydrate and sucrose).
_Excipients with known effect _
Each MINULETTE 75 µg/30 µg active tablet contains 37,43 mg lactose
monohydrate and 19,661 mg
sucrose.
Each inactive (placebo) tablet contains 33,15 mg lactose monohydrate
and 17,879 mg sucrose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets.
21 white round, biconvex film-coated tablets with a shiny surface,
approximately 5,7 mm in diameter.
7 red to reddish/pink, round, biconvex film-coated tablets,
approximately 6 mm in diameter.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MINULETTE is indicated for the prevention of pregnancy.
Pfizer Laboratories (Pty) Ltd
Page 2 of 24
Minulette 75/30 micrograms film-coated tablets
Final Approved PI: 04 October 2021
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_How to take MINULETTE _
In MINULETTE 28-day packs, tablets 1 - 21 contain active ingredients
(active tablets) and tablets 22
- 28 do not contain any active ingredients (inactive tablets).
MINULETTE must be taken in the order as directed on the package and at
the same time every day,
preferably after the evening meal or at bedtime. One active tablet is
to be taken daily for 21
consecutive days, then either followed by 7 days of inactive (placebo)
tablets or a 7- day tablet-free
interval.
Each subsequent pack is started on the day after the last inactive
tablet. A withdrawal bleed usually
starts on days 2 - 3, after the last active tablet, and may not have
finished before the next pack is
started. The tablets are taken daily, and pack follows pack without