PACKAGE LEAFLET: INFORMATION FOR THE USER SZ00000LT000

Tranexamic acid 500 mg Tablets

Tranexamic acid

Read all of this leaflet carefully before you start taking 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.

•    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, pharmacist 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 500 mg Tablets are and what they are used for

2.    What you need to know before you take Tranexamic acid 500 mg Tablets

3.    How to take Tranexamic acid 500 mg Tablets

4.    Possible side effects

5.    How to store Tranexamic acid 500 mg Tablets

6.    Contents of the pack and other information

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What Tranexamic acid 500 mg Tablets are and what they are used for

Tranexamic acid 500 mg Tablets belong to a group of medicines called anti-fibrinolytic 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 500 mg Tablets stop these clots dissolving and so reduces unwanted bleeding.

Tranexamic acid 500 mg Tablets are 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 angioneurotic oedema (HANO). A doctor will have told you if you have this.

What you need to know before you take Tranexamic acid 500 mg Tablets

Do not take Tranexamic acid 500 mg Tablets if you:

•    are allergic to active substance or any of the other ingredients of this medicine (listed in section 6).

•    have a history of blood clots (e.g. in your legs or lungs).

•    have kidney failure.

•    have a history of fits (convulsions).

•    are at risk of excessive bleeding as a result of a bleeding disorder called consumption coagulopathy.

If any of the above applies to you, do not use this medicine and talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tranexamic acid 500 mg Tablets, if you:

•    have ever had blood clots such as in your legs (deep vein

thrombosis, “DVT” or lungs), or you have a family history of a blood clotting disease e.g. thrombophillia.

•    have disseminated intravascular coagulation (DIC), a disease that affects blood clotting.

•    have blood present in your urine.

•    have ever had uncontrolled bleeding.

•    are pregnant, think you might be pregnant or are breast-feeding.

•    have been taking this 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.

•    have kidney disease.

•    have irregular menstrual bleeding.

•    are being treated for heavy periods and are under 15 years of age.

•    are taking the contraceptive pill.

If any of the above applies to you, talk to your doctor or pharmacist. It is possible that this medicine may not be suitable for you, or you may need some additional advice.

Other medicines and Tranexamic acid 500 mg Tablets

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

•    Fibrinolytic drugs (used to help dissolve blood clots), such as streptokinase. This is because Tranexamic acid 500 mg Tablets will stop these drugs working

•    Oral contraceptives. These may increase the risk of blood clots forming.

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 or pharmacist for advice before taking this medicine.

Driving and using machines

Tranexamic acid 500 mg Tablets do not effect the ability to drive and use machinery.

3 How to take Tranexamic acid 500 mg 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.

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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.

The recommended doses are:

Adults and older people:

After Prostate surgery: 2 tablets taken 3 or 4 times per day.

During heavy periods: 2 tablets taken 3 times per day, for up to 4 days.

During Nose Bleeds: 2 tablets taken 3 times per day for 7 days. After Cervical Surgery: 3 tablets taken 3 times a day.

Tooth extraction in haemophiliacs: 2-3 tablets every 8 hours.

Hereditary angioneurotic oedema: 2-3 tablets taken 2 or 3 times a day for several days.

Children: 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.

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 500 mg 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. Symptoms of overdosage are: nausea (feeling sick), sickness (vomiting) and feelings of severe dizziness or lightheadedness. There is a risk of a blood clot (thrombosis), possibly causing difficulty breathing, or swollen ankle and pain in the calf or thigh. If you are able to, you should try to make yourself vomit.

If you forget to take Tranexamic acid 500 mg Tablets

Do not take a double dose to make up for a forgotten dose.

Simply take the next dose as planned. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Gastrointestinal disorders

Very rare (may affect up to 1 in 10,000 people)

•    Feeling sick (nausea)

•    Being sick (vomiting)

•    Diarrhoea.

These are usually mild and pass very quickly, but if they continue, tell your doctor or pharmacist.

Skin and subcutaneous tissue disorders

Rare (may affect up to 1 in 1,000 people)

•    Itchy, red or swollen skin.

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 (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Tranexamic acid 500 mg Tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister strip and carton after EXP. The expiry date refers to the last day of that month.

Do not store these tablets above 25°C. Store in the original package.

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

4 Possible side effects

Like all medicines, this medicine can cause side effects, although

not everybody gets them.

Eye disorders

Rare (may affect up to 1 in 1,000 people)

•    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

Immune system disorders

Very rare (may affect up to 1 in 10,000 people)

•    This includes allergic reactions which can include a skin rash which may be raised or itchy, swelling of your face, eyelids, lips or tongue, sudden wheezing, chest pain or tightness, breathing difficulties or dizziness, collapse.

Vascular disorders

Rare (may affect up to 1 in 1,000 people)

•    A blood clot in your blood vessels (called a 'thrombosis'). Signs of which may include pain or feelings of heaviness in your chest, unusual pain or swelling in your arms or legs, sudden shortness of breath, fainting, coughing up blood

Very rare (may affect up to 1 in 10,000 people)

•    Tiredness with low blood pressure, with or without loss of consciousness.

Nervous system disorders

Very rare (may affect up to 1 in 10,000 people)

•    Fits (convulsions).

What Tranexamic acid 500 mg Tablets contain

•    The active substance is tranexamic acid. One tablet contains 500 mg of tranexamic acid.

•    The other ingredients are microcrystalline cellulose, hydroxypropylcellulose, purified talc, hydrogenated vegetable oil, magnesium stearate, silica colloidial anhydrous and povidone.

What Tranexamic acid 500 mg Tablets look like and contents of the pack

Tranexamic acid 500 mg Tablets are white capsule shaped tablets market ‘T500' on one side and a break line on the other.

Tranexamic acid 500mg Tablets are available in packs of 60. Marketing Authorisation Holder

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, U.K.

Manufacturer

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK OR FAMAR L'AIGLE, Z.I. No1 route de Crulai, F.61300 L'Aigle, France.

This leaflet was last revised in 06/2016.

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