APO-TRANEXAMIC ACID tranexamic acid 500 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tranexamic acid, Quantity: 500 mg

Available from:

Southern Cross Pharma Pty Ltd

INN (International Name):

Tranexamic acid

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; purified talc; colloidal anhydrous silica; povidone; vanillin; macrogol 8000; magnesium stearate; titanium dioxide; basic butylated methacrylate copolymer

Administration route:

Oral

Units in package:

100 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Oral Administration Hereditary angioneurotic oedema. Short term use in the treatment of hyphaema and in patients with established coagulopathies who are undergoing minor surgery. Menorrhagia.

Product summary:

Visual Identification: White to slightly yellowish, film coated, capsule shaped, biconvex, 18 mm x 8 mm, with a break-line and embossed "TXA 500"; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-01-30

Patient Information leaflet

APO-Tranexamic acid tablets
1
APO-TRANEXAMIC
ACID
_Contains the active ingredient tranexamic acid _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about APO-
TRANEXAMIC ACID.
It does not contain all of the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking APO-
TRANEXAMIC ACID against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your medicine.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
APO-TRANEXAMIC ACID is used
to prevent bleeding in patients with:
Traumatic hyphaema (bleeding into
the front part of the eye)
Blood clotting disorders, who are
having minor surgery
Heavy periods
Hereditary angioneurotic oedema
(periodic swelling of the throat)
APO-TRANEXAMIC ACID
contains tranexamic acid.
Tranexamic acid is an antifibrinolytic
that works by slowing the processes
that cause bleeding.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF:
•
HAVE AN ALLERGY TO TRANEXAMIC
ACID OR ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET
•
ARE BEING TREATED FOR STROKE
•
ARE BEING TREATED FOR BLOOD CLOTS
IN YOUR LEGS, LUNGS OR ANYWHERE
ELSE IN YOUR BODY
•
HAVE A PROBLEM WITH COLOUR
VISION THAT DEVELOPED AFTER YOU
WERE BORN.
•
THE EXPIRY DATE (EXP.) PRINTED
ON THE PACK HAS PASSED.
•
THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
DO NOT USE APO-TRANEXAMIC
ACID TO TREAT ANY OTHER COMPLAINT
UNLESS YOUR DOCTOR TELLS YOU TO.
BEFORE YOU START TO TAKE IT
TELL YOUR DOCTOR IF YOU HAVE
ANY OF THE FOLLOWING:
•
you, or someone in your family,
has ever suffered from blood clots
•
severe bruising
•
kidney disease with or without
blood in the urine
•
irregular periods and the reason is
not known
TELL YOUR DOCTOR IF YOU H

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
APO-TRANEXAMIC ACID 500MG TABLETS
_ _
1.
NAME OF THE MEDICINE
Tranexamic Acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-Tranexamic Acid tablets contain the active ingredient tranexamic
acid.
Each APO-Tranexamic Acid tablet contained 500mg of tranexamic acid.
Tranexamic acid is a white crystalline powder that is odourless or
almost odourless. It is
freely soluble
in water and in glacial acetic acid, practically insoluble in
methanol, ethanol,
acetone, diethyl ether
and benzene.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
The tablets contain 500 mg tranexamic acid. Tablets are white to
slightly yellowish, film coated, capsule
shaped, biconvex, 18 mm x 8 mm, with a break-line and embossed “TXA
500”.
The tablets are packed in PVC/aluminium foil blister packs of 100
tablets and bottles of 100 tablets (white
HDPE bottles with PP child-resistant tamper evident screw cap and
silica gel desiccant).
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Hereditary angioneurotic oedema.
Short term use in the treatment of hyphaema and in patients with
established coagulopathies
who
are undergoing minor surgery.
Menorrhagia.
4.2. DOSE AND METHOD OF ADMINISTRATION
ORAL ADMINISTRATION
TRAUMATIC HYPHAEMA
1.0 to 1.5 g every 8 hours for six to seven days.
MENORRHAGIA
Two tablets (1 g) four times a day, increasing to three tablets (1.5
g) four times a day if needed,
for four days. Treatment should be initiated at the onset of visible
bleeding, and continued for the
first 4 days of the menstrual cycle. Patients should be assessed after
three
months of treatment.
APO-Tranexamic Acid – AUSTRALIAN PRODUCT INFORMATION
2
No efficacy data are available from randomised, controlled clinical
trials for treatment
beyond three
menstrual cycles.
HEREDITARY ANGIONEUROTIC OEDEMA
Patients who can sense the onset of attacks are best treated
intermittently with 2 - 3 tablets, 2- 3 times
a day until symptoms subside. Others should be treated continuously
with the