Consumer medicine information

1. Why am I taking Cyklokapron?

Cyklokapron contains the active ingredient tranexamic acid. Cyklokapron is used to prevent or reduce excessive bleeding in patients: who experience bleeding inside the eye; that have heavy periods; that experience periodic severe swelling of the throat; after prostate surgery; are undergoing minor surgery and have a blood clotting disorder. For more information, see Section 1. Why am I using Cyklokapron? in the full CMI.

2. What should I know before I take Cyklokapron?

Do not use if you have ever had an allergic reaction to tranexamic acid or any of the ingredients listed at the end of the CM I, are being treated for stroke or blood clots or have a problem with colour vision that developed after you were born.
Tell your doctor if you, or someone in your family has ever suffered from blood clots, severe bruising, convulsion, fits or seizures; kidney disease with or without blood in the urine, unexplained irregular periods. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take Cyklokapron? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Cyklokapron and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take Cyklokapron?

Your doctor will decide how many tablets you need. It will depend on why you are taking this medicine and if you have kidney disease.
More instructions can be found in Section 4. How do I use Cyklokapron? in the full CMI.

5. What should I know while taking Cyklokapron?

6. Are there any side effects?

The side effects include allergic reactions such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing; unexpected pain, swelling, warmth or redness in your legs or arms; convulsions, fits or seizures; giddiness or dizziness; changes in your eyesight including colour vision; blood clot or bleeding in the eye or loss of vision; itchy, red or swollen skin; nausea; vomiting; diarrhoea.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Tranexamic acid.

2 Qualitative and Quantitative Composition

Each Cyklokapron tablet contains 500 mg of tranexamic acid.

3 Pharmaceutical Form

Cyklokapron is available as film coated tablets. Cyklokapron is a white, capsule shaped tablet with a score on one side and "CY" within upper and lower arcs on the other.

4 Clinical Particulars

4.9 Overdose

Overdose data are limited. There is one report of overdosage in which a seventeen year old ingested 37 g of tranexamic acid and after receiving treatment with gastric lavage, mild intoxication was reported.
Symptoms of overdose may include dizziness, headache, nausea, vomiting, diarrhoea, orthostatic symptoms, hypotension and convulsions.
There is no known antidote for tranexamic acid overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures should be instituted as required.
Activated charcoal may reduce absorption of tranexamic acid if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube once the airway is protected.
In addition to this, monitor vital signs to detect a possible hypotensive episode. Monitor fluid and electrolyte status in patients with severe vomiting or diarrhoea and administer IV fluids and replace electrolytes as necessary. Monitor urine output and maintain adequate diuresis. Monitor for clinical evidence of thromboembolic complications (e.g. chest pain, shortness of breath, flank pain, extremity pain). Because there is a risk of thrombosis in predisposed individuals, anticoagulant therapy should be considered in these patients.
In symptomatic patients, support respiratory and cardiac function. Monitor blood count, renal function, pulse oximetry and/or blood gases and obtain a chest X-ray. Obtain an ECG and institute continuous cardiac monitoring.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Tranexamic acid was not mutagenic in B. subtilis and had no chromosomal effects in Chinese hamster cells. The incidence of chromosomal breakage was increased at 3 g/kg in rat bone marrow. No lethal mutagenicity was detected in a dominant lethal test at 100 mg/kg and 3 g/kg. The weight of evidence in a limited range of mutagenicity tests suggests that tranexamic acid is not mutagenic.
Carcinogenicity. A dietary carcinogenicity study in Shermann-Wyckoff rats showed an increase in the incidence of biliary hyperplasia, cholangioma and adenocarcinoma of the liver at high doses. However, these findings have not been reproduced in a number of other lifetime studies in either SD or CDF1 mice. A possible treatment related increase in the incidence of leukaemia was noted in mice receiving dietary tranexamic acid at doses equivalent to up to 5 g/kg/day for 20 months.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

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.
Chemical structure. The chemical structure of tranexamic acid is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTRAACI.gif Chemical name: trans-4-aminomethylcyclohexane-carboxylic acid.
The molecular formula of tranexamic acid is C₈H₁₅NO₂ and its molecular weight is 157.2.
CAS number. 1197-18-8.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/CYKLOKST.gif