Patient leaflet - Tranexamic Acid 500 mg film-coated tablets
1. What Tranexamic Acid Tablets is and what it is used for
Tranexamic Acid Tablets contains the active substance Tranexamic Acid and belongs to a group of medicines called antifibrinolytic drugs. These are used to stop or reduce unwanted bleeding. When you bleed your body forms clots to stop the bleeding. In some people these break down causing too much bleeding. Tranexamic Acid Tablets stops these clots dissolving and so reduces unwanted bleeding.
Tranexamic Acid Tablets is used to prevent or reduce bleeding for a short period of time in many different conditions. You may have been prescribed it for one of the following:
Following prostate surgery
(post-prostatectomy)
- Following bladder surgery
- Heavy periods (menorrhagia) • Nose bleeds (epistaxis)
- Cervical surgery (conisation of the cervix)
- Bleeding inside the eye (traumatic hyphaema)
- Tooth removal (dental extraction) in haemophiliacs (people who bleed more easily than normal). You will know if this refers to you
- A hereditary disease called angioedema. A doctor will have told you if you have this.
2. What you need to know before you take Tranexamic Acid Tablets
Do not take Tranexamic Acid Tablets if:
- You are allergic to Tranexamic Acid or any of the other ingredients of this medicine (listed in section 6). • You have serious problems with your kidneys (kidney failure)
- You have or have ever had a blood clot in your blood vessels (called a `thrombosis’).
- You have a history of convulsions • You are at risk of excessive bleeding as a result of a bleeding disorder called consumption coagulopathy
If any of the above applies to you talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Tranexamic Acid Tablets if:
You have blood in your urine. This may increase the risk of blockage of the urinary tract
Package leaflet: Information for the user
Tranexamic Acid
Tranexamic Acid 500 mg Film-coated Tablets
You have ever had any
uncontrollable bleeding
- You take oral contraceptives. These may increase the risk of blood clots forming
- You have disseminated intravascular coagulation (DIC), a disease where your blood starts to clot throughout your body
- You have been taking medicine to treat a hereditary disease called angioedema every day for a long time. If so, you may need to have regular eye tests and blood tests to check your liver is working properly • You are a woman with irregular periods
- You or your family have a history of blood clots in your blood vessels (called a `thrombosis’)
- Anyone in your family has suffered from blood clots in their blood vessels • You have kidney disease.
Other medicines and Tranexamic Acid Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular the following:
- Fibrinolytic drugs (used to help dissolve blood clots), such as streptokinase. This is because Tranexamic Acid Tablets will stop these drugs working
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, 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 machines
Tranexamic Acid Tablets has no or little effect on the ability to drive and use machines. Visual disturbances may occur after taking tranexamic acid.
3. How to take Tranexamic Acid Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Important:
Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your
pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.
Remember: Your medicine should always be taken with a glass of water. The tablets should be swallowed whole. Do not crush or chew them.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Use in adults and elderly:
- The usual dose is 2 or 3 tablets taken two to three times daily
- The exact dose you take will depend on why you have been prescribed these tablets
- Follow your doctor’s instructions about how many tablets to take, when to take them and for how long.
Use in children and adolescents:
- Your doctor will tell you exactly how much medicine you should give your child. They will work out the dose according to how much your child weighs.
Use in patients with kidney problems:
- Your doctor will tell you how much to take. The dose you take may be lower than the usual adult dose.
If you take more Tranexamic Acid Tablets than you should
If you accidentally take too much of your medicine, immediately tell your doctor or go to the nearest hospital casualty department.
Taking too much Tranexamic Acid Tablets may cause diarrhoea or may make you feel sick, be sick or be dizzy or light-headed upon standing.
If you forget to take Tranexamic Acid Tablets
Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Tranexamic Acid Tablets can cause side effects, although not everybody gets them. Stop taking Tranexamic Acid Tablets and go immediately to hospital if you experience any of the following symptoms:
Rare: may affect up to 1 in 1,000 people
a blood clot in your leg or lungs, the symptoms of which may include: √ pain, swelling or redness in your leg √ difficulty breathing or shortness of breath
√ chest pain, which may get worse while breathing
Very rare: may affect up to 1 in 10,000 people
an allergic reaction, the symptoms of which may include:
√ swelling of your throat and tongue √ difficulty breathing or shortness of breath
√ difficulty swallowing, tightness in your throat or a hoarse voice √ wheezing, coughing or noisy breathing
√ a rash that is swollen, raised or itchy
Frequency not known (cannot be estimated from the available data)
- sudden onset kidney problems due to death of the tissue in the outer part of the kidney (acute renal cortical necrosis)
Stop taking Tranexamic Acid Tablets and tell your doctor immediately if you experience any of the following symptoms:
Rare: may affect up to 1 in 1,000 people
- itchy, red or swollen skin
- problems with your eyesight, especially your colour vision • a blood clot in your eye. This may cause bleeding in the eye, or a loss of vision
Very rare: may affects up to 1 in 10,000 people
- a blood clot in your blood vessels (called a `thrombosis’)
- feeling sick, being sick, diarrhoea. These are usually mild and pass very quickly, but if they continue, tell your doctor or pharmacist.
Frequency not known (cannot be estimated from the available data)
- seizures, particularly in cases of misuse
- an allergic reaction that usually recurs at the same site(s) on re-exposure to the medication and may include round or oval patches of redness and swelling of the skin, blistering, and itching (fixed drug eruption). Darkening of the skin in affected areas, which might persist after healing, may also occur.
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 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
5. How to store Tranexamic Acid Tablets
Keep this medicine out of the sight and reach of children.
Do not use Tranexamic Acid Tablets after the expiry date on the carton. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 information
What Tranexamic Acid Tablets contains
- The active substance is Tranexamic Acid. Each Tablet contains 500 mg Tranexamic Acid.
The other ingredients are Core: Cellulose, microcrystalline,
Hydroxypropyl cellulose, low-substituted, Povidone, colloidal anhydrous silica, Talc, Magnesium stearate; Coating: Instacoat White T2F A17E00196 Containing
Hypromellose/ HPMC 2910, Sodium Lauryl sulfate, Polyethylene glycol, Propylene Glycol, Calcium
Carbonate.
What Tranexamic Acid Tablets looks like and contents of the pack
Off-white to light pale yellow color capsule shape, film-coated tablets with one side break line and other side plain with approximately 8.0 mm x 18.0 mm dimension.
Tranexamic Acid Tablets are available in cartons containing 20, 30, 50, 60 and 100 Tablets in blisters. They are also available in bottle containing 100 tablets. Each carton contains one bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orbit Pharma Limited
128 City Road, London,
United Kingdom, EC1V 2NX
Manufacturer
SCIOM LIMITED
Unit 4, Martinfield Business Centre, Martinfield, Welwyn Garden City, AL7 1HG, United Kingdom
This leaflet was last revised in June 2026.