Each film-coated tablet contains Tranexamic acid 500 mg
Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis.
Local fibrinolysis as occurs in the following conditions:
- Prostatectomy and bladder surgery.
- Conisation of the cervix.
- Traumatic hyphaema.
- Hereditary angioneurotic oedema.
- Management of dental extraction in haemophiliacs.
Dosage and Administration
Route of administration: Oral.
The recommended standard dosage is 15-25 mg/kg bodyweight (i.e. 2-3 tablets) two to three times daily.
For the indications listed below the following doses may be used:
- Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence per- or post-operatively with an SAVIBLEED Injection; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present.
- 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 SAVIBLEED should not be initiated until menstrual bleeding has started.
- Epistaxis: Where recurrent bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days.
- Conisation of the cervix: 3 tablets three times daily.
- Traumatic hyphaema: 2-3 tablets three times daily. The dose is based on 25 mg/kg three times a day.
Haemophilia: In the management of dental extractions 2-3 tablets every eight hours. The dose is based on 25 mg/kg.
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.
Children's dosage: This should be calculated according to body weight at 25 mg/kg per dose.
Elderly patients: No reduction in dosage is necessary unless there is evidence of renal failure.
Hypersensitivity to tranexamic acid or any of the other ingredients.
Severe renal impairment because of risk of accumulation.
Active thromboembolic disease.
History of venous or arterial thrombosis.
Fibrinolytic conditions following consumption coagulopathy.
History of convulsions.
Immune system disorders:
Very rare: Hypersensitivity reactions including anaphylaxis.
Vascular disorders :
Rare: Thromboembolic events.
Very rare: Arterial or venous thrombosis at any sites.
Very rare: Digestive effects such as nausea, vomiting and diarrhoea, may occur but disappear when the dosage is reduced.
Skin and subcutaneous tissue disorders.
Rare: Allergic skin reactions.
Pregnancy and Lactation
Although there is no evidence from animal studies of a teratogenic effect, the usual caution with the use of drugs in pregnancy should be observed. Tranexamic acid crosses the placenta.
Tranexamic acid passes into breast milk to a concentration of approximately one hundredth of the concentration in the maternal blood. An antifibrinolytic effect in the infant is unlikely.
Warning and Precaution
In case of haematuria of renal origin (especially in haemophilia), there is a risk of mechanical anuria due to formation of a ureteral clot.
In the long-term treatment of patients with hereditary angioneurotic oedema, regular eye examinations (e.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.
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. Therefore a dose reduction is recommended.
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.
Package and Storage
Carton box containing 1, 2, 3 or 4 strips each of 10 film coated tablets and insert leaflet.
Store at temperature not exceeding 30ºC in a dry place.