TRANEXAMIC ACID 500MG TABLETS

Active substance: TRANEXAMIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tranexamic acid 500 mg Tablets

SZ00000LT000

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 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.

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

1

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.

2

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.

3
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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 or pharmacist 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 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.
The recommended doses are:

Adults and Elderly:
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 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, this medicine can cause side effects, although
not everybody gets them.
Eye disorders
Rare (affects 1 to 10 users in 1,000)
• 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 (affects less than 1 user in 10,000)
• 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 (affects 1 to 10 users in 1,000)
• 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

Gastrointestinal disorders
Very rare (affects less than 1 user in 10,000)
• 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 (affects 1 to 10 users in 1,000)
• 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

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
Custom Pharmaceuticals Limited, Conway Street, Hove, East
Sussex, BN3 3LW, U.K OR 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 08/2014.

Very rare (affects less than 1 user in 10,000)
• Tiredness with low blood pressure, with or without loss of
consciousness.
Nervous system disorders
Very rare (affects less than 1 user in 10,000)
• Fits (convulsions).

SZ00000LT000

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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