Product Name: Tranexamic acid 1000 mg coated granules in sachet. Composition: Each sachet of coated granules contains tranexamic acid 1000 mg. Indication: This medicine is for the reduction of heavy menstrual bleeding (menorrhagia) over several cycles in women with regular, 21-35 day cycles with no more than 3 days individual variability in cycle duration. Posology and administration: 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. Special populations: 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 (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. Serum creatinine (micromole/L) 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. Contraindications: This medicine for menorrhagia is contraindicated in women with: Active thromboembolic disease, Severe renal impairment (risk of accumulation), History of convulsions, Patients taking combined hormonal contraceptives, Hypersensitivity to the active substance or to any of the excipients listed in the full summary of product characteristics. Warnings and precautions: 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. Therefore a dose reduction is recommended. 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, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Pregnancy: Should not be used during pregnancy. Breastfeeding: Tranexamic acid is excreted in breast milk, but a risk for an impact on the child seems unlikely at therapeutic doses. Breastfeeding can therefore be continued during this medicine therapy. Fertility: No data. Undesirable effects: Dose-dependent gastrointestinal discomfort is the most commonly reported undesirable effect, but it is usually of mild and temporary nature. Common (≥ 1/100 to < 1/10): Dizziness, Headache, Vomiting, Diarrhoea, Nausea, Abdominal pain. Uncommon (≥ 1/1,000 to < 1/100): Allergic skin reaction. Not known: Convulsions, Impaired colour vision and other visual disturbances, Thromboembolic events NHS price: £14.95. per box of 12 sachets. Legal classification: POM. MA numbers: PL 46938/0001. Marketing Authorisation Holder: CEMAG CARE, 55 rue de Turbigo, 75003 Paris, France. Further information is available on request from: Consilient Health (UK) Ltd, No.1 Church Road, Richmond upon Thames, Surrey TW9 2QE, or drugsafety@consilienthealth.com Job Code: UK-GEN-192 Date of preparation of PI: October 2025