Tranexamic acid Tillomed 500 mg film-coated Tablets

• 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. See section 4.

1. What Tranexamic acid Tillomed tablets are and what they are used for
2. What you need to know before you use Tranexamic acid Tillomed tablets
3. How to use Tranexamic acid Tillomed tablets
4. Possible side effects
5. How to store Tranexamic acid Tillomed tablets
6. Contents of the pack and other information

• 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.

Talk to your doctor or pharmacist before taking Tranexamic acid Tillomed tablets if:

• You have blood in your urine. This may increase the risk of blockage of the urinary tract
• 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 angioneurotic oedema (HANO) 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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines (including medicines obtained without a prescription), in particular the following:

• Fibrinolytic drugs (used to help dissolve blood clots), such as streptokinase. This is because Tranexamic acid Tillomed tablets will stop these drugs working

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.

Tranexamic acid Tillomed tablets has no or little effect on the ability to drive and use machines. Visual disturbances may occur after taking tranexamic acid.

Tranexamic acid Tillomed tablets contain castor oil. This can cause stomach upset and diarrhoea.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

This medicine contains 5.50% w/w, propylene glycol as an ingredient necessary for the medicine to work properly.

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 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.

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.

Your doctor will tell you how much to take. The dose you take may be lower than the usual adult dose.

If you accidentally take too much of your medicine, immediately tell your doctor or go to the nearest hospital casualty department.

Taking too many Tranexamic acid Tillomed tablets may cause diarrhoea or may make you feel sick, be sick or be dizzy or light-headed upon standing.

Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.

• an allergic reaction: swelling of your throat and/or tongue, difficulty swallowing, difficulty breathing or shortness of breath, dizziness
• itchy, red or swollen skin rash
• pain, swelling or redness in your leg
• chest pain

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 affect up to 1 in 10,000 people)

• a blood clot in your blood vessels (called a `thrombosis’)
• feeling sick (nausea) or being sick (vomiting), diarrhoea. These are usually mild and pass very quickly, but if they continue, tell your doctor or pharmacist
• diarrhoea. This is usually mild and passes very quickly, but if it continues, tell your doctor or pharmacist.

Frequency not known (cannot be estimated from the available data)

• Seizures, particularly in cases of misuse.

If you get any side effects, talk to your doctor or pharmacist. 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 provide more information on the safety of this medicine.

The active substance is Tranexamic acid. Each tablet contains 500 mg Tranexamic acid.

The other ingredients are: cellulose microcrystalline, starch pregelatinised, low substituted hydroxypropyl cellulose, silica colloidal anhydrous, povidone, talc, castor oil hydrogenated, magnesium stearate, hypromellose, titanium dioxide, macrogol, propylene glycol, sodium lauryl sulfate.

Tranexamic acid Tillomed tablets are off white to pale yellow, oval shaped film-coated tablet plain on both sides.

Tranexamic acid Tllomed tablets are supplied in:

Blister packs (OPA/Alu/PVC) containing 10, 20, 30, 50, 60 and 100 tablets.

HDPE (High density polyethylene) bottles containing 100 tablets.

Not all pack sizes are marketed.

Marketing Authorisation Holder

Manufacturer¹