Cyklokapron

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Buy It Now

Active ingredient:

Tranexamic acid

Available from:

Pfizer Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

                                CYKLOKAPRON
 
_Tranexamic acid tablets and solution for injection_
CONSUMER MEDICINE INFORMATION
   
 
 
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
CYKLOKAPRON. This leaflet
answers some common questions
about CYKLOKAPRON.
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
CYKLOKAPRON against the
expected benefits it will have for
you.
Use CYKLOKAPRON as instructed
and follow the advice given in this
leaflet.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with the medicine.
You may need to read it again.
WHAT CYKLOKAPRON
IS USED FOR
CYKLOKAPRON is used to prevent
excessive 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)
It may also be used to reduce
bleeding and the need for transfusion
of blood in patients undergoing heart
surgery, total knee replacement and
total hip replacement surgery.
HOW CYKLOKAPRON
WORKS
CYKLOKAPRON contains
tranexamic acid. Tranexamic acid is
an antifibrinolytic that works by
slowing the processes that cause
bleeding.
BEFORE TAKING
CYKLOKAPRON
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CYKLOKAPRON IF
YOU HAVE AN ALLERGY TO
CYKLOKAPRON OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
DO NOT TAKE CYKLOKAPRON IF
YOU ARE BEING TREATED FOR A STROKE.
DO NOT TAKE CYKLOKAPRON IF
YOU ARE BEING TREATED FOR BLOOD
CLOTS IN YOUR LEGS, LUNGS OR
ANYWHERE ELSE IN YOUR BODY.
DO NOT TAKE CYKLOKAPRON IF
YOU HAVE A PROBLEM WITH COLOUR
VISION THAT DEVELOPED AFTER YOU
WERE BORN.
DO NOT TAKE CYKLOKAPRON
AFTER THE EXPIRY DATE (EXP) PRINTED
ON THE PACK.
If you take this medicine after the
expiry date has passed, it may not
work as well.
DO NOT TAKE CYKLOKAPRON IF
TH
                                
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Summary of Product characteristics

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Page 1 of 27 
PRODUCT INFORMATION 
CYKLOKAPRON
®
 
TRANEXAMIC ACID 
NAME OF THE MEDICINE 
Tranexamic acid  
The chemical structure of tranexamic acid is: 
 
Chemical name:  trans-4-aminomethylcyclohexane-carboxylic acid. 
The molecular formula of tranexamic acid is C
8
H
15
NO
2
 and its molecular weight is 157.2.  
The CAS number for tranexamic acid is 1197-18-8. 
DESCRIPTION 
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. 
The pKa:  4.3 and 10.6. 
Each CYKLOKAPRON  tablet  contains 500 mg of tranexamic acid  as well as the following 
inactive  ingredients:  cellulose-microcrystalline,  talc-purified,  magnesium  stearate,  colloidal 
anhydrous  silica,  povidone,  hydroxypropylcellulose,  titanium  dioxide,  macrogol 8000, 
vanillin and the proprietary ingredient, Eudragit E100
(ID Number 1753). 
CYKLOKAPRON  solution  for  injection  is  a  sterile,  clear,  colourless  solution.    The  pH  is 
6.5 to 8.0. 
Each 5 mL ampoule of CYKLOKAPRON solution for injection contains 500 mg tranexamic 
acid and 5 mL Water for Injections as the inactive ingredient. 
Each  10 mL  ampoule  of  CYKLOKAPRON  solution  for  injection  contains  1000 mg 
tranexamic acid and 10 mL Water for Injections as the
inactive ingredient. 
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PHARMACOLOGY 
PHARMACODYNAMICS 
Tranexamic  acid  is  a  competitive  inhibitor  of  plasminogen  activation  and  at  much  higher 
concentrations  a  noncompetitive  inhibitor  of  plasmin,  thus  implying  that 
                                
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