MINULET tablet
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
ethinylestradiol,gestodene
Available from:
Pfizer Australia Pty Ltd
INN (International Name):
ethinylestradiol,Gestodene
Authorization status:
Registered
Patient Information leaflet
MINULET
®
_Gestodene and Ethinylestradiol Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Minulet. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Minulet
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY QUESTIONS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT MINULET IS USED
FOR
Minulet is an oral contraceptive.
Minulet tablets contain two
hormones (gestodene and
ethinylestradiol), which prevent you
from becoming pregnant if taken
correctly. They are similar to the
hormones that your body normally
produces.
Minulet prevents pregnancy in
several ways:
•
It inhibits the egg release by
stopping it maturing
•
It changes the cervical mucus
consistency making it difficult for
the sperm to reach the egg
•
It changes the lining of the uterus
making it less suitable for
implantation.
Your doctor may have prescribed
Minulet for another reason. Ask your
doctor if you have any questions
about why Minulet has been
prescribed for you.
Minulet is not habit-forming.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
MINULET
_WHEN YOU MUST NOT TAKE_
_MINULET_
Do not take Minulet if you have an
allergy to:
•
ANY MEDICINE CONTAINING
ETHINYLESTRADIOL OR GESTODENE
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
•
ANY OTHER SIMILAR MEDICINES
(SUCH AS OTHER ORAL
CONTRACEPTIVES).
Some of the symptoms of an allergic
reaction may include:
•
Shortness of breath
•
Wheezing or difficulty breathing
•
Swelling of the face, lips, tongue
or other parts of the body
•
Rash, itching or hives on the skin.
DO NOT TAKE MINULET IF YOU HAVE OR
HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
Venous thromboembolism (VTE)
and are on medicines called
anticoagul
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Summary of Product characteristics
Version: pfpminut10120
Supersedes: pfpminut11018
Page 1 of 25
AUSTRALLIAN PRODUCT INFORMATION -
MINULET
(GESTODENE AND
ETHINYLESTRADIOL) TABLETS
1. NAME OF THE MEDICINE
Gestodene and Ethinylestradiol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each white active tablet contains ethinylestradiol 30 µg and
gestodene 75 µg.
Each red tablet is a placebo tablet.
EXCIPIENTS WITH KNOWN EFFECT
Sucrose
Lactose monohydrate
For the full list of excipients, see section 6.1, List of Excipients.
3. PHARMACEUTICAL FORM
Tablets.
MINULET
calendar blister pack consists of 28 tablets: 21 white tablets and 7
red placebo
tablets.The white active tablets are round, biconvex tablets,
approximately 6 mm in diameter.
The red inert tablets are round, biconvex coated tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MINULET is indicated for the prevention of pregnancy.
4.2 DOSE AND METHOD OF ADMINISTRATION
HOW TO TAKE MINULET
Each package of MINULET contains 21 active white tablets and 7 red
inactive tablets.
Version: pfpminut10120
Supersedes: pfpminut11018
Page 2 of 25
To achieve maximum contraceptive effectiveness, MINULET must be taken
as directed and at
daily intervals not exceeding 24 hours. Women should be instructed to
take the tablets at the
same time every day, preferably at bedtime.
HOW TO START MINULET
_NO PRECEDING HORMONAL CONTRACEPTIVE USE (IN THE PAST MONTH) _
On the first day of the menstrual cycle, i.e. the first day of
bleeding, the woman is instructed to
take a white active tablet corresponding to that day of the week from
the purple section of the
MINULET pack. Thereafter, one white active tablet is taken daily,
following the arrows
marked on the package, until all 21 white active tablets have been
taken from the pink section.
The woman should be instructed then to take one red inactive tablet
daily for the next seven
days following the arrows marked on the MINULET pack. Withdrawal
bleeding should
usually occur within 2 to 4 days after the last white active tablet is
taken. The woman should
b
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