What it is and what it is used for

for Tranexamic Acid 500mg/5ml Solution for Injection (called Tranexamic Acid Solution for Injection throughout the rest of this leaflet) contains tranexamic acid which belongs to a group of medicines called antihaemorragics; antifibrinolytics, aminoacids. Tranexamic acid is used in adults and children above one year of age for the prevention and treatment of bleeding due to a process that inhibits blood clotting called fibrinolysis. Specific uses include:

• heavy periods in women;
• gastrointestinal bleeding;
• haemorrhagic urinary disorders after having an operation on your prostate gland or urinary tract;
• after having an operation on your ear, nose or throat;
• after having heart, abdominal or gynaecological surgery;
• bleeding after you have been treated with another medicine to break down blood clots.

What you need to know before you take it

Tranexamic Acid Solution for Injection Do not have Tranexamic Acid Solution for Injection:

• If you are allergic (hypersensitive) to tranexamic acid or any of the other ingredients of this medicine (see section 6)
• If you currently have or have ever had a disease leading to blood clots
• If you have a condition called "consumption coagulopathy" where blood in the whole body starts to clot
• If you have kidney problems
• If you have a history of convulsions (fits) •

Due to the risk of seizures and brain swelling, Tranexamic Acid Solution for Injection must not be given into the spine, epidurally (around the spinal cord) or into the brain.

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If you think any of these apply to you, or if you are in any doubt at all, tell your doctor before you are given Tranexamic Acid Solution for Injection. Warnings and precautions Talk to your doctor or nurse before you are given Tranexamic Acid Solution for Injection:

• This medicine is ONLY to be given to you through a vein either by intravenous infusion (IV) or intravenous injection (IV push). This medicine must not be given into the spine, epidurally (around the spinal cord) or into the brain. Serious harms have been reported when this medicine was given into the spine (intrathecal use). If you notice any pain in your back or legs during, or soon after this medicine is given, tell your doctor or nurse immediately.
• If you have had blood in your urine, it may lead to urinary tract obstruction.
• If you are at risk of having blood clots.
• If you suffer from excessive clotting or bleeding throughout your body (disseminated intravascular coagulation). Tranexamic Acid Solution for Injection may not be right for you, except if you have acute severe bleeding and blood test have shown the process that inhibits blood clotting called fibrinolysis is activated.
• If you have had convulsions. Tranexamic Acid Solution for Injection should not be administered. Your doctor must use the minimal dose possible to avoid convulsions following treatment with Tranexamic Acid Solution for Injection.
• If you are on long term treatment with Tranexamic Acid Solution for Injection, attention should be paid to possible disturbances of colour vision and if necessary the treatment should be discontinued. With continuous long term use of Tranexamic Acid Solution for Injection Ophthalmologic examinations (eye examinations including visual acuity, colour vision, fundus, visual field etc.) are indicated. With pathological ophthalmic changes, particularly with diseases of the retina, your doctor must take a decision after consulting a specialist on the necessity for the long-term use of Tranexamic Acid Solution for Injection in your case. Other medicines and Tranexamic Acid Solution for Injection Tell your doctor, pharmacist or nurse if you are taking, or have recently taken, or might take any other medicines, including medicines obtained without a prescription. You should specifically tell them if you take:
• Other medicines that help blood to clot, called antifibrinolytic medicines;
• Medicines that prevent blood clotting, called thrombolytic medicines;
• Oral contraceptives. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Breastfeeding Tranexamic acid is excreted in breast milk. Therefore, the use of Tranexamic Acid Solution for Injection during breast-feeding is not recommended. Driving and using machines

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No studies have been performed on the ability to drive and use machines.

How to take it

Tranexamic Acid Solution for Injection will be given to you by a slow injection into your vein. Tranexamic Acid Solution for injection must not be injected into a muscle, into the spine, epidurally (around the spinal cord) or into the brain. Your doctor will decide the correct dose for you and how long you should take it. Check with your doctor if you are not sure. Use in Adults

• Treatment of Local Fibrinolysis: The usual dose is 500-1000mg (5-10ml) three times a day. This will usually be given by a slow injection into your vein.
• Treatment of General Fibrinolysis: The usual dose if 1000mg (10ml) every 6 to 8 hours, or up to 15mg per Kg of body weight. Use in Children
• If Tranexamic Acid Solution for Injection is given to a child over one year old, the dose will be based on the child's body weight.
• The doctor will decide the right dose to give your child and how long he or she should take it. Use in Elderly No reduction in dose is necessary unless you have kidney problems. Use in Patients with Kidney Problems If you have kidney problem, your dose of tranexamic acid will be reduced according to a test performed on your blood (serum creatinine level). Use in Patients with Liver Problems No reduction in dose is necessary. Method of Administration Tranexamic Acid Solution for Injection should only be administered slowly into a vein. Tranexamic Acid Solution for Injection must not be injected into a muscle. If you are given more Tranexamic Acid Solution for Injection than you should If you are given more Tranexamic Acid Solution for Injection than the recommended dose, you may experience a transitory blood pressure lowering (you may feel faint or dizzy on standing). Talk to a doctor or pharmacist immediately. If you have any further questions on the use of this medicine, ask your doctor or nurse.

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4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following side effects after you have been given your medicine, tell your doctor immediately. If you are not in hospital, you MUST GO straight away. These side effects are rare but serious. •

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Severe allergic reaction which may include a red and lumpy skin rash, difficulty breathing, swelling of face, mouth, lips or eyelids, unexplained high temperature (fever) and feeling faint. If the swelling affects your throat and makes breathing and swallowing difficult, go to hospital straight away. Symptoms of a blood clot which may include swelling or pain in your legs or chest, headache, weakness of the face and limbs on one side of the body.

Other side effects which may occur: Common (may affect up to 1 in 10 users)

• effects on the stomach and intestines: nausea, vomiting and diarrhoea. Uncommon (may affect up to 1 in 1000 users)
• effects on the skin problems: rash. Not known (the frequency cannot be estimated from the available data)
• low blood pressure (you may feel generally unwell, faint or dizzy on standing) with or without loss of consciousness, especially if the injection being given too quickly
• dizziness
• blood clots
• effects on the nervous system: fits (convulsions)
• effects on the eyes: vision disturbances, including impaired colour vision
• Sudden onset kidney problems due to death of the tissue in the outer part of the kidney (acute renal cortical necrosis)
• An allergic reaction that usually recurs at the same site(s) on re-exposure to the medication and may include round or oval patches of redness and swelling of the skin, blistering, and itching (fixed drug eruption). Darkening of the skin in affected areas, which might persist after healing, may also occur. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any

Possible side effects

not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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How to store it

Tranexamic Acid Solution for Injection Keep this medicine out of the sight and reach of children. Do not use this medicine after expiry date which is stated on the carton and vial label after 'EXP'. The expiry date refers to the last day of that month. Do not store above 25°C. Store in the original packaging. Do not refrigerate or freeze. This product is for single use only. Once your doctor or nurse has opened the vial, it should be used immediately. Any remaining Tranexamic Acid Solution for Injection must be thrown away by the doctor or nurse. 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

Contents of the pack and other information

What Tranexamic Acid Solution for Injection contains

• The active substance is tranexamic acid. Each 5ml vial contains 500mg tranexamic acid (100mg per ml).
• The other ingredient is water for injections. What Tranexamic Acid Solution for Injection looks like and contents of the pack This medicine is a clear, colourless solution in a clear, glass vial. Each vial contains 5ml of medicine. This product is available in cartons containing 10 x 5ml vials. Marketing Authorisation Holder Focus Pharmaceuticals Limited, Dashwood House, 69 Old Broad Street, London, EC2M 1QS, United Kingdom Manufacturer Medochemie Ltd, Ampoule Injectable Facility, 48 Iapetou Street, Avios Athanasios Industrial estate, 4101, Limassol, Cyprus. This leaflet was last revised in April 2026.

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<——————————————————————————————————-> Technical Leaflet intended for healthcare professionals only TRANEXAMIC 500MG/5ML SOLUTION FOR INJECTION GENERAL INFORMATION Tranexamic Acid 500mg/5ml Solution for Injection is for single use only. Any portion of the vial not used at once should be discarded. THERAPEUTIC INDICATIONS Prophylaxis/treatment of haemorrhage due to general or local fibrinolysis in adults and children over one year due to:

• Menorrhagia and metrorrhagia;
• Gastrointestinal bleeding;
• Haemorrhagic urinary disorders, following prostate surgery or procedures on the urinary tract;
• Ear, nose and throat surgery;
• Gynaecological or obstetric surgery;
• Thoracic and abdominal surgery;
• Haemorrhagic complications in association with thrombolytic therapy. POSOLOGY AND METHOD OF ADMINISTRATION Tranexamic 500mg/5ml Solution for Injection should be administered by slow intravenous injection according to the dosage schedule below. THERAPEUTIC DOSE Adult: Local Fibrinolysis: 5-10ml (500-1000mg) by slow intravenous injection (1ml/min), three times a day. General Fibrinolysis: 10ml (1000mg) by slow intravenous injection (1ml/min), every 6 to 8 hours, equivalent to 15mg/kg body weight. Paediatrics: From one year, for the current approved indications, the dosage is in the region of 20mg/kg/day. Elderly: No reduction in dosage is necessary unless there is evidence of renal failure. Renal Failure: Due to the risk of accumulation, the dose should be reduced according to the following table: Serum Creatinine 120-249mcmol/l

Dose iv 10mg/kg BW

Dose Frequency every 12 hours

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250-500mcmol/l >500mcmol/l

10mg/kg BW 5mg/kg BW

every 24 hours every 24 hours

Method of administration: Slow intravenous injection only. Each ampoule may contain more than the stated 5ml of liquid. This is to ensure that the full 5ml amount is available. Only 5ml should be withdrawn from the ampoule for administration to the patient. Any portion of the ampoule not used at once should be discarded. STORAGE AND DISPOSAL OF TRANEXAMIC ACID SOLUTION FOR INJECTION Do not store above 25°C. Store in the original packaging. Do not refrigerate or freeze. The product should be used immediately after opening. Any unused product or waste material should be disposed of in accordance with local requirements. Shelf life: Unopened:

30 months

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