TRIPHASIL ethinylestradiol/levonorgestrel tablet blister pack

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

ethinylestradiol, Quantity: 0.03 mg; levonorgestrel, Quantity: 0.125 mg

Boleh didapati daripada:

Pfizer Australia Pty Ltd

Borang farmaseutikal:

Tablet, sugar coated

Komposisi:

Excipient Ingredients: glycerol; calcium carbonate; glycol montanate; purified talc; macrogol 6000; povidone; lactose monohydrate; iron oxide yellow; magnesium stearate; maize starch; titanium dioxide; sucrose

Laluan pentadbiran:

Oral

Unit dalam pakej:

1 x 28 tablets, 4 x 28 tablets

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

TRIPHASIL is indicated for the prevention of pregnancy.

Ringkasan produk:

Visual Identification: 10 yellow round biconvex 6mm diameter tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Registered

Tarikh kebenaran:

1991-07-04

Risalah maklumat

TRIPHASIL
®
_Levonorgestrel and Ethinylestradiol Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Triphasil. 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 Triphasil
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 TRIPHASIL IS USED
FOR
Triphasil is an oral contraceptive,
commonly known as a "birth control
pill" or "the Pill". Triphasil 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.
Triphasil 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 TRIPHASIL HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Triphasil for another reason.
This medicine is available only with
a doctor's prescription.
Triphasil is not habit-forming.
This medicine is not expected to
affect your ability to drive a car or
operate machinery.
BEFORE YOU TAKE
TRIPHASIL
_WHEN YOU MUST NOT TAKE_
_TRIPHASIL_
DO NOT TAKE TRIPHASIL 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,

Ciri produk

Version: pfptript11219
Supersedes: pfptript11118
Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION -
TRIPHASIL
 (LEVONORGESTREL AND
ETHINYLESTRADIOL) TABLETS
1. NAME OF THE MEDICINE
Levonorgestrel and Ethinylestradiol.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each brown tablet contains 30 microgram of ethinylestradiol and 50
microgram of levonorgestrel.
Each white tablet contains 40 microgram of ethinylestradiol and 75
microgram of levonorgestrel.
Each yellow tablet contains 30 microgram of ethinylestradiol and 125
microgram of 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.
EACH BLISTER CONTAINS
6 brown tablets, followed by 5 white tablets, followed by 10 yellow
tablets
and followed by 7 red inert tablets.
Brown tablets: Round, biconvex, sugar coated brown tablets.
White tablets: Round, biconvex, sugar coated white tablets.
Yellow tablets: Round, biconvex, sugar coated yellow tablets.
Red tablets: Round, biconvex, sugar coated red inert tablets.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TRIPHASIL is indicated for the prevention of pregnancy.
Version: pfptript11219
Supersedes: pfptript11118
Page 2 of 28
4.2 DOSE AND METHOD OF ADMINISTRATION
_HOW TO TAKE TRIPHASIL _
Each package of TRIPHASIL contains 6 brown active tablets, 5 white
active tablets, 10 yellow
active tablets and 7 red inactive tablets. To achieve maximum
contraceptive effectiveness,
TRIPHASIL 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 TRIPHASIL _
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 tablet
corresponding to that day of the week from the shaded section of the
TRIPHASIL pack