Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Tranexamic acid
Pfizer Australia Pty Ltd
Medicine Registered
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 Read the complete document
Version: pfpcyklt10313 Supercedes: pfpcyklt10112 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. Version: pfpcyklt10313 Supercedes: pfpcyklt10112 Page 2 of 27 PHARMACOLOGY PHARMACODYNAMICS Tranexamic acid is a competitive inhibitor of plasminogen activation and at much higher concentrations a noncompetitive inhibitor of plasmin, thus implying that Read the complete document