TRANEXAMIC ACID

Posology Recommended dosage is 1 sachet 3 times daily as long as needed for up to 4 days (1 sachet every 6 to 8 hours). If very heavy menstrual bleeding, dosage may be increased. A total dose of 4 g daily (4 sachets) should not be exceeded.

Treatment with this medicine should not be initiated until menstrual bleeding has started. Renal impairment By extrapolation from clearance data relating to the intravenous dosage form, the following reduction in the oral dosage is recommended for patients with mild to moderate renal insufficiency.

Serum creatinine Dose tranexamic acid (micromole/l) 120-249 Body weight 60kg and above: 15 mg/kg body weight twice daily Body weight below 60kg: 15 mg/kg body weight once daily 250-500 Body weight 60kg and above: 15 mg/kg body weight once daily Body weight below 60kg: 15 mg/kg body weight once every other day The maximum dose at each administration in subjects with renal impairment is 1000 mg.

Therefore, do not use more than 1 sachet per dose. Paediatric population Clinical experience with this medicine in menorrhagic children under 15 years of age is not available. Method of administration Oral use. Coated granules may be taken with a glass of water.

Mixing with semi-solid food has not been studied.

Dose-dependent gastrointestinal discomfort is the most commonly reported undesirable effect, but it is usually of mild and temporary nature. Tabulated list of adverse reactions Adverse reactions frequency is defined using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 4) Gastrointestinal disorders Vomiting, Diarrhoea, Nausea, Abdominal pain Skin and subcutaneous tissue disorders Allergic skin reaction Fixed drug eruption Eye disorders Impaired colour vision and other visual disturbances Vascular disorders Thromboembolic events Renal and urinary disorders Acute renal cortical necrosis Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Patients with irregular menstrual bleeding should not use this medicine until the cause of irregular bleeding has been established. If menstrual bleeding is not adequately reduced by this medicine, an alternative treatment should be considered.

Patients with a previous thromboembolic event and a family history of thromboembolic disease (patients with thrombophilia) should use this medicine only if there is a strong medical indication and under strict medical supervision. Patients experiencing heavy bleeding during hormonal contraceptive use should not start treatment with tranexamic acid, but are advised to contact their Healthcare Professional.

The blood levels are increased in patients with renal insufficiency. 2). The use of tranexamic acid in cases of increased fibrinolysis due to disseminated intravascular coagulation is not recommended. In haematuria from the upper urinary tract clot formation can, in a few cases, lead to ureteric obstruction.

Convulsions Cases of convulsions have been reported in association with tranexamic acid treatment, most of these cases were reported following intravenous injection in high doses.

Excipients:

This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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