TRANEXAMIC ACID TILLOMED

Posology 1. e. 2- 3 tablets) two to three times daily. For the indications listed below the following doses may be used: 1a.

Prostatectomy:

Prophylaxis and treatment of haemorrhage in high risk patients should commence pre- or post-operatively with Tranexamic Acid Injection; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present.

1b.

Menorrhagia:

Recommended dosage is 2 tablets 3 times daily as long as needed for up to 4 days. If very heavy menstrual bleeding, dosage may be increased. A total dose of 4g daily (8 tablets) should not be exceeded. Treatment with Tranexamic acid should not be initiated until menstrual bleeding has started.

1c.

Severe epistaxis:

Where recurrent bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days. 1d. Conisation of the cervix: 3 tablets three times daily for 12-14 days. 1e. Prevention of recurrent haemorrhage in traumatic hyphaema: 2-3 tablets three times daily for 7 days.

The dose is based on 25 mg/kg three times a day. 2.

Hereditary angioneurotic oedema:

Some patients are aware of the onset of the illness; suitable treatment for these patients is intermittently 2-3 tablets two to three times daily for some days. Other patients are treated continuously at this dosage. 3.

Haemophilia:

In the management of dental extractions 2-3 tablets every eight hours for 6- 8 days. The dose is based on 25 mg/kg.

Renal insufficiency:

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.

Children's dosage:

This should be calculated according to body weight at 25 mg/kg per dose. However, data on efficacy, posology and safety for these indications are limited.

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/l0), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10,000 and <1/1000) and very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).

Immune system disorders Very rare:

Hypersensitivity reactions including anaphylaxis Eye disorders Rare: Colour vision disturbances, retinal/artery occlusion Cardiac disorders Very rare: malaise with hypotension, with or without loss of consciousness (usually followed by an intravenous too fast, exceptionally after oral administration) Vascular disorders Rare: Thromboembolic events Very rare: Arterial or venous thrombosis at any sites Gastro-intestinal disorders Very rare: Digestive effects such as nausea, vomiting and diarrhoea, may occur but disappear when the dosage is reduced.

4) Renal and urinary disorders Frequency not known: 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.

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In case of haematuria of renal origin (especially in haemophilia), there is a risk for urinary obstruction at the lower levels of the tract. If left untreated, urinary obstruction may lead to serious consequences such as renal insufficiency, urinary tract infection, hydronephrosis, and anuria.

Therefore, close monitoring is recommended for those patients with haematuria or risk of haematuria from the upper urinary tract. g. visual acuity, slit lamp, intraocular pressure, visual fields) and liver function tests should be performed.

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

Tranexamic acid should be administered with care in patients receiving oral contraceptives because of the increased risk of thrombosis. Patients with a previous thromboembolic event and a family history of thromboembolic disease (patients with thrombophilia) should use Tranexamic acid only if there is a strong medical indication and under strict medical supervision.

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. Patients who experience visual disturbance should be withdrawn from treatment.

Clinical experience with Tranexamic acid in menorrhagic children under 15 years of age is not available. Cases of convulsions have been reported in association with tranexamic acid treatment. ) injection of tranexamic acid in high doses.

Tranexamic acid Tillomed 500 mg film-coated tablets contain sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

• Hypersensitivity to tranexamic acid or any of the excipients listed in section 6. • Severe renal impairment (Serum Creatinine > 500 μmol/l) because of risk of accumulation • Active thromboembolic disease • History of venous or arterial thrombosis • Fibrinolytic conditions following consumption coagulopathy • History of convulsions Serum Creatinine (μmol/l) Dose tranexamic acid 120-249 15 mg/kg body weight twice daily 250-500 15 mg/kg body weight/day