Tranexamic Acid 100 mg/ml Solution for Injection

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

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

• If you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6)
• If you have currently 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

Due to the risk of cerebral oedema and convulsions, intrathecal and intraventricular injection and intracerebral application are not recommended.

If you think any of these apply to you, or if you are in any doubt at all, tell your doctor before taking Tranexamic Acid.

Talk to your doctor or nurse if any of these apply to you to help him or her decide if Tranexamic Acid is suitable for you:

• If you have had blood in your urine, it may lead to urinary tract obstruction.
• If you have a risk of having blood clots.
• If you have excessive clotting or bleeding throughout your body (disseminated intravascular coagulation), Tranexamic Acid may not be right for you, except if you have acute severe bleeding and blood tests have shown the process that inhibits blood clotting called fibrinolysis is activated.
• If you have had convulsions, Tranexamic Acid should not be administered. Your doctor must use the minimal dose possible to avoid convulsions following treatment with Tranexamic Acid.
• If you are on a 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, regular 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 in your case.

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.

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 breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Tranexamic Acid is excreted in human milk. Therefore, the use of Tranexamic Acid during breast-feeding is not recommended.

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

If Tranexamic Acid solution for injection is given to a child from one year, the dose will be based on the child’s weight.

Your doctor will decide the correct dose for the child and how long he/she should take it.

No reduction in dosage is necessary unless there is evidence of renal failure.

If you have a kidney problem, your dose of tranexamic acid will be reduced according to a test performed on your blood (serum creatinine level).

No reduction in dosage is necessary.

Tranexamic Acid should only be administered slowly into a vein.

Tranexamic Acid must not be injected into a muscle.

If you are given more Tranexamic Acid than the recommended dose you may experience a transitory blood pressure lowering. Talk to a doctor or pharmacist immediately.

The following side effects have been observed with Tranexamic Acid

Common: may affect up to 1 in 10 people

• effects on the stomach and intestines: nausea, vomiting, diarrhoea

Uncommon: may affect up to 1 in 100 people

• effects on the skin problems: rash

Not known: frequency cannot be estimated from the available data

• malaise with hypotension (low blood pressure), especially if the injection is given too quickly
• blood clots
• effects on the nervous system: convulsions
• effects on the eyes: vision disturbances including impaired colour vision
• effects on the immune system: allergic reactions

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 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.

• The active substance is tranexamic acid.
• Each 5 ml of the solution contains 500 mg of tranexamic acid.
• Each 10 ml of the solution contains 1000 mg of tranexamic acid.
• The other ingredient is water for injections.

Tranexamic Acid is a clear, colourless solution.

Packs with 1, 5 or 10 multi or non-multi Type I glass 5 ml ampoule in outer carton, each ampoule containing 500 mg tranexamic acid.

Packs with 1, 5 or 10 multi or non-multi Type I glass 10 ml vial in outer carton, each vial containing 1000 mg tranexamic acid.

Not all pack sizes may be marketed.

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