Patient leaflet - TRANEXAMIC ACID 100 MG / ML SOLUTION FOR INJECTION
Read all of this leaflet carefully before you 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, 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.
What is in this leaflet
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1. What Tranexamic Acid Solution for Injection is and what it is given for
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2. What you need to know before you are given Tranexamic Acid Solution for Injection
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3. How Tranexamic Acid Solution for Injection is given
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4. Possible side effects
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5. How to store Tranexamic Acid Solution for Injection
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6. Contents of the pack and other information
1. What Tranexamic Acid Solution for Injection is and what it is given for
Tranexamic Acid 100mg/ml 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 given 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
2. what you need to know before you are given 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 (listed in 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.
Warnings and precautions
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 have 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 (fits). 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 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 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.
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 and breast-feeding
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
No studies have been performed on the ability to drive and use machines.
3. How Tranexamic Acid Solution for Injection is given
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.
The recommended dose is:
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 too much Tranexamic Acid Solution for Injection
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.
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.
- 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:
effects on the stomach and intestines: nausea, vomiting and diarrhoea.Uncommon (may affect up to 1 in 100 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 is given too quickly
- 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.
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: 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..
5. how to store 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 ampoule label after ‘EXP’. The expiry date refers to the last day of that month.
Your pharmacist will check this before the injection is given. The unopened ampoules have no special storage precautions.
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.
6. contents of the pack and other informationtranexamic acid injection is a solution for injection in glass ampoules containing 500mg in 5ml solution.
Tranexamic Acid Injection also contains water for injections.
Contents of the pack:
Tranexamic Acid Injection is available in packs of 5 × 5ml glass ampoules.
Marketing Authorisation Holder and Manufacturer
Mercury Pharmaceuticals Limited,
Capital House, 85 King William Street, London EC4N 7BL, UK
Manufacturer:
BIOINDUSTRIA L.I.M.,
Laboratorio Italiano Medicinali S.p.A.,
Via De Ambrosiis, 2,
15067 Novi Ligure, Italy
This leaflet was last revised in July 2020