MONOFEME levonorgestrel and ethinylestradiol tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ethinylestradiol,levonorgestrel

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

ethinylestradiol,Levonorgestrel

Authorization status:

Registered

Patient Information leaflet

MONOFEME
®
_Levonorgestrel and Ethinylestradiol Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Monofeme.
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
Monofeme 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 MONOFEME IS
USED FOR
Monofeme is an oral contraceptive,
commonly known as a "birth control
pill" or "the Pill". Monofeme tablets
contain two hormones
(levonorgestrel and ethinylestradiol),
which prevent you from becoming
pregnant if taken correctly. They are
similar to the hormones that your
body normally produces.
Monofeme 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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY MONOFEME
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Monofeme for another reason.
This medicine is available only with
a doctor's prescription.
Monofeme is not habit-forming.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
MONOFEME
_WHEN YOU MUST NOT TAKE_
_MONOFEME_
DO NOT TAKE MONOFEME IF YOU HAVE
AN ALLERGY TO:
•
ANY MEDICINE CONTAINING
ETHINYLESTRADIOL OR
LEVONORGESTREL
•
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 h

Summary of Product characteristics

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AUSTRALIAN PRODUCT INFORMATION -
MONOFEME
® (LEVONORGESTREL AND
ETHINYLESTRADIOL) TABLETS
1. NAME OF THE MEDICINE
Levonorgestrel and Ethinylestradiol
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
white
active
tablet
contains
30
micrograms
ethinylestradiol
and
150
micrograms
levonorgestrel.
Each red tablet contains no active ingredients.
EXCIPIENTS WITH KNOWN EFFECT

Sucrose

Lactose monohydrate
For the full list of excipients, see Section 6.1 - List of Excipients.
3. PHARMACEUTICAL FORM
Tablet, sugar coated.
MONOFEME package contains 28 tablets; 21 active white tablets and 7
placebo red tablets.
White tablets: Shiny, smooth, sugar coated white tablets.
Red tablets: Round, biconvex, sugar coated red to reddish-pink inert
tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MONOFEME is indicated for the prevention of pregnancy.
4.2 DOSE AND METHOD OF ADMINISTRATION
_HOW TO TAKE MONOFEME _
Each package of MONOFEME contains 21 white active tablets and 7 red
inactive tablets.
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To achieve maximum contraceptive effectiveness, MONOFEME must be taken
as directed and at
intervals not exceeding 24 hours. Women should be instructed to take
the tablets at the same time
every day, preferably after the evening meal or at bedtime.
_HOW TO START MONOFEME _
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 will take the first
white active tablet corresponding to that day of the week from the
green shaded section of the
MONOFEME package. Thereafter, one white active tablet is taken daily,
following the arrows on
the package, until all 21 white active tablets have been taken. The
woman should then be instructed
to take one red tablet from the light shaded section of the MONOFEME
pack daily for the next
seven days following the arrows marked. Withdrawal bleeding should
usually occur within 3 days
after t