Tranexamic Acid 500mg/5ml Solution for Injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Tranexamic Acid Solution for Injection is and what it is used for
2. What you need to know before you are given Tranexamic Acid Solution for Injection
3. How Tranexamic Acid Solution for Injection is given
4. Possible side effects
5. How to store Tranexamic Acid Solution for Injection
6. Contents of the pack and other information

• 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 fits or swelling in the brain, injection into the spinal cord, directly into the heart or into the brain is not recommended.

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.

Talk to your doctor or nurse before you are given Tranexamic Acid Solution for Injection:

• 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.

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.

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.

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

• 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.

• 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.

No reduction in dose is necessary unless you have 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).

No reduction in dose is necessary.

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 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.

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

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.

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.

• The active substance is tranexamic acid. Each 5ml vial contains 500mg tranexamic acid (100mg per ml).
• The other ingredient is water for injections.

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.