Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Tranexamic acid may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Tranexamic Acid 500 mg Tablets contain the active substance tranexamic acid, which belongs to a group of medicines known as anti-fibrinolytics which are used to stop or reduce unwanted bleeding. When you bleed your body forms clots to stop the bleeding. In some people these break down causing too much bleeding. Tranexamic acid stops these clots dissolving and so reduces unwanted bleeding. Tranexamic Acid 500 mg Tablets is used to prevent or reduce bleeding for a short period of time in many different conditions. You may have been prescribed this medicine for one or more of the following:
e Tranexamic Acid 500 mg Tablets Do not take Tranexamic Acid 500 mg Tablets
section 6).
Tranexamic Acid 500 mg Tablets Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Important: Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist. Your medicine should always be taken with a glass of water. The tablets should be swallowed whole. Do not crush or chew them. The breakline is not intended for breaking the tablet.
Use in adults and the elderly The usual dose is 2 or 3 tablets taken two or three times daily.
4. Possible side effects Like all medicines this medicine can cause side effects, although not everybody gets them. Stop taking this medicine and seek immediate medical advice if you experience any of the following: Rare: may affect up to 1 in 1,000 people • a blood clot in your leg or lungs, the symptoms of which may include: − pain, swelling or redness in your leg − difficulty breathing or shortness of breath − chest pain, which may get worse while breathing Very rare: may affect up to 1 in 10,000 people • an allergic reaction, the symptoms of which may include: − swelling of your throat and tongue − difficulty breathing or shortness of breath − difficulty swallowing, tightness in your throat or a hoarse voice − wheezing, coughing or noisy breathing − a rash that is swollen, raised or itchy Stop taking this medicine and tell your doctor immediately if you experience any of the following:
Rare: may affect up to 1 in 1,000 people
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Tranexamic Acid 500 mg Tablets Keep all medicines out of the sight and reach of children. Do not store above 25°C. Keep in the original package. Do not use this medicine after the expiry date that is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Tranexamic Acid 500 mg Tablets contain The active substance is tranexamic acid. Each tablet contains 500 mg of tranexamic acid. The other ingredients are: microcrystalline cellulose, povidone K90, croscarmellose sodium, colloidal anhydrous silica, talc, magnesium stearate, methacrylate polymers, titanium dioxide (E171), macrogol 8000 and vanillin. What Tranexamic Acid 500 mg Tablets look like and the contents of the pack Tranexamic Acid 500 mg Tablets are film-coated, white to off-white, oblong and biconvex with a breakline and marked "TA" on one side of the breakline.
They are available in blister packs of 12 and 60 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom. Manufacturer Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom This leaflet was last revised in March 2026 PL 06464/1373
Tranexamic Acid 500 mg Tablets
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 01268 535200 (select option Medical Information) / e-mail: [email protected]
Tranexamic Acid 500 mg Tablets comes as tablet containing 500mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Tranexamic Acid 500 mg Tablets is tranexamic acid.
Medicines with the same active substance, strength and form include: Evana Heavy Period Relief 500 mg tablets, Tranexamic acid Tillomed 500 mg film-coated Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Tranexamic Acid 500 mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
1. Short-term use for haemorrhage or risk of haemorrhage in increased fibrinolysis or fibrinogenolysis. Local fibrinolysis as occurs in the following conditions:
a) Prostatectomy and bladder surgery
b) Menorrhagia
c) Epistaxis
d) Conisation of the cervix
e) Traumatic hyphaema
2. Hereditary angioneurotic oedema
3. Management of dental extraction in haemophiliacs
Posology
1. Local fibrinolysis
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:
a) Prostatectomy: Prophylaxis and treatment of haemorrhage in high risk patients should commence pre- or post-operatively with intravenous tranexamic acid injection; thereafter 2 tablets three to four times daily until macroscopic haematuria is no longer present.
b) 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.
c) Epistaxis: Where recurrent bleeding is anticipated oral therapy (2 tablets three times daily) should be administered for 7 days.
d) Conisation of the cervix: 3 tablets three times daily.
e) Traumatic hyphaema: 2-3 tablets three times daily. 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. The dose is based on 25 mg /kg bodyweight.
Renal insufficiency: By extrapolation from clearance data relating to the intravenous dosage form, the following reduction in oral dosage is recommended for patients with mild to moderate renal insufficiency.
Serum Creatinine (μmol/l)
Dose Tranexamic acid
120-249
15 mg/kg body weight twice daily
250-500
15 mg/kg body weight/day
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.
Elderly patient's dosage:
No reduction in dosage is necessary unless there is evidence of renal insufficiency (see above).
Method of administration
For oral administration
Severe renal impairment because of risk of accumulation.
Hypersensitivity to tranexamic acid or any of the excipients, listed in section 6.1.
Active thromboembolic disease.
History of venous or arterial thrombosis.
Fibrinolytic conditions following consumption coagulopathy.
History of convulsions.
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.
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.
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. Therefore, a dose reduction is recommended (see section 4.2).
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. In cardiac surgery, most of these cases were reported following intravenous (i.v.) injection of tranexamic acid in high doses.
Tranexamic acid counteracts the thrombolytic effect of fibrinolytic preparations.
Pregnancy
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.
Breast-feeding
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.
Tranexamic acid has no or negligible influence on the ability to drive and use machines. Visual disturbances may occur following administration of tranexamic acid.
Adverse events are listed below by system organ class and frequency.
Frequencies are defined as: very common (≥1/10), 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
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.
Skin and subcutaneous tissue disorders
Rare: Allergic skin reactions
Not known: Fixed drug eruption
Nervous system disorders
Frequency not known: Convulsions particularly in cases of misuse (refer to sections 4.3 and 4.4)
Renal and urinary disorders
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Signs and symptoms may include nausea, diarrhoea, vomiting, orthostatic symptoms and/or hypotension, dizziness, headache and convulsions. Initiate vomiting, then stomach lavage, and charcoal therapy. Maintain a high fluid intake to promote renal excretion. There is a risk of thrombosis in predisposed individuals. Anticoagulant treatment should be considered.
Ask anything about Tranexamic Acid 500 mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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