Tranexamic Acid 500mg/5ml Solution for Injection

Read all of this leaflet carefully before you, or your child, are given this medicine because it contains important information for you.

• 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.

What is in this leaflet:

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

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, Other information);
• currently have or have ever had a disease leading to blood clots;
• have a condition called “consumption coagulopathy” where blood in the whole body starts to clot;
• have kidney problems;
• 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.

Warnings and precautions

Tell your doctor if any of the following apply to you, to help him or her decide if Tranexamic Acid Solution for Injection is suitable for you:

• if you have had blood in your urine, which could indicate that there is a clot in your upper urinary tract;
• if you are at risk of having blood clots;
• if you suffer from excessive clotting or bleeding throughout your body (disseminated intravascular coagulation). Your doctor may carry out a blood test to see if the process that inhibits blood clotting (called fibrinolysis) is activated;
• if you have had convulsions (fits). Your doctor will use the minimum dose possible to avoid further convulsions after the treatment;
• if you are on long term treatment with Tranexamic Acid Solution for Injection pay attention to any possible disturbances in your colour vision. If necessary, your doctor may discontinue the treatment. With continuous, long term use of Tranexamic Acid Solution for Injection regular eye tests are recommended. If changes are seen in your eyes, your doctor may consult an eye specialist in order to decide whether to continue your treatment.

Other medicines and Tranexamic Acid Solution for Injection

Please tell your doctor 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 your doctor 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

• Ask your doctor for advice if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
• 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

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

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 is 1000mg (10ml) every 6 to 8 hours, or up to 15mg per kg of body weight.

Use in Children

• The doctor will decide the right dose to give your child and how long he or she should take it.
• 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.

Use in Elderly

No reduction in dose is necessary unless you have kidney problems.

Use in Patients with Kidney Problems

If you have problems with your kidneys, the dose may be reduced. Your doctor will decide what dose to give you based on a blood test.

Use in Patients with Liver Problems

No reduction in dose is necessary.

Method of Administration

Tranexamic Acid Solution for Injection should only be injected slowly into a vein. It should not be injected into a muscle.

If you are given too much Tranexamic Acid Solution for Injection

If you are given too much Tranexamic Acid Solution for Injection, you may experience temporary low blood pressure (you may feel faint or dizzy on standing). Talk to your doctor or nurse immediately.

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.

• 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)

• feeling sick;
• being sick;
• diarrhoea.

Uncommon (may affect up to 1 in 1000 users)

• 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) which is usually caused by an injection being given too quickly;
• fits;
• visual disturbances, including colour disturbance.

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

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

Manufacturer

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

Other sources of information

For information in large print, audio CD or Braille please telephone

00 44 (0)1283 495 280 or email [email protected]