Tranexamic Acid 100mg/Ml Solution For Injection
MercuryPharma PATIENT INFORMATION LEAFLET
Tranexamic Acid 100mg/ml Solution for Injection
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet
1. What Tranexamic Acid Injection is and what it is used for
2. Before you are given Tranexamic Acid Injection
3. How Tranexamic Acid Injection is given to you
4. Possible side effects
5. Storing Tranexamic Acid Injection
6. Contents of the pack and other information
• Tranexamic Acid Injection is a solution for injection. The active ingredient is tranexamic acid, which belongs to a group of medicines called antifibrinolytic agents, which are used to stop excessive bleeding after an operation or to assist with blood clotting. When you bleed your body forms clots as part of healing. In some people these clots do not stay in place long enough and this can cause too much bleeding.
• Tranexamic Acid Injection can be used after minor surgery in people with a hereditary blood clotting disorder (haemophiliacs) and may also be used if you suffer from a serious condition called ‘disseminated intravascular coagulation' where blood in the whole body starts to clot.
• Tranexamic Acid Injection can also be given to stop the bleeding after you have been treated with another medicine to break down blood clots (thrombolysis).
Do not take Tranexamic Acid:
• If you are allergic (hypersensitive) to tranexamic acid or any of the other ingredients of this medicine (listed in section 6).
• If you have a history of blood clots (thromboembolism), especially in the leg or lung Warnings and precautions
Talk to your doctor or pharmacist before being given Tranexamic Acid Injection:
• If you have kidney disease as the medicine can accumulate in your body and therefore a lower dose might be given to you (see Section 3).
• If you have bleeding from the upper urinary tract- this shows as blood in your urine.
• If you have ever had any uncontrollable bleeding.
• If you are pregnant or breastfeeding.
• If you are being treated for disseminated intravascular coagulation.
Tranexamic Acid Injection will only be given if your doctor has done blood tests to check you are suitable, otherwise other anti-clotting medicines may be a given instead.
Other medicines and Tranexamic Acid Injection
There are no special interactions with Tranexamic Acid Injection, however please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machinery
As with all medicines, caution should be taken when driving or operating machinery following treatment with Tranexamic Acid Injection until you are fully recovered.
Tranexamic Acid Injection will usually be given to you by slow injection (1 ml/min) into a vein. It can also be diluted and given by infusion (through ‘a drip').
Adults
The usual dose is 5 to 10 ml three times a day, but the doctor will decide the correct dose for you and how long you should take it for depending on your condition. If you need to be treated for longer than three days, the doctor may decide to switch you to tablets.
Children
If Tranexamic Acid Injection is given to a child the dose will be worked out based on the child's weight.
The elderly
In elderly patients the dose may be reduced if your kidneys are not working properly.
Tranexamic Acid Injection should not be added to blood for transfusion or to injections containing penicillin.
Like all medicines Tranexamic Acid Injection can cause side effects although not everyone gets them. Important side effects to look out for:
You must get urgent medical help if you have any of the following symptoms. You may be having an allergic reaction:
• You have difficulty breathing.
• Your face or throat swell.
• Your skin develops a severe rash.
Other possible side effects:
• Effects on your heart and circulation: Tranexamic Acid Injection may temporarily lower blood pressure, especially if the injection is given too quickly.
Rarely, blood clots (thromboembolism) in the lungs or legs have been reported. However, these also occur in people who have had an operation and are not taking Tranexamic Acid Injection. If you develop any pains in your chest or legs contact your doctor immediately.
• Effects on the nervous system: If the injection is given too quickly, you can feel dizzy. Seizures/fits have also been reported.
• Effects on your stomach and intestines: Nausea (feeling sick), vomiting (being sick) and diarrhoea have been reported. These often go away if the dose is reduced.
If you experience any of the above side effects or notice any other unusual effects not mentioned in this leaflet, tell your doctor or pharmacist at once.
Tranexamic Acid Injection should not be used after the expiry date printed on the box and on the ampoule. Your pharmacist will check this before the injection is given. The unopened ampoules have no special storage precautions.
As with all medicines keep the ampoules out of the sight and reach of children.
What Tranexamic Acid Injection contains:
Tranexamic 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 x 5ml glass ampoules.
Marketing Authorisation Holder:
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 December 2013.
102002/LF/2