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TRANEXAMIC ACID 500MG TABLETS

Active substance: TRANEXAMIC ACID

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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.
• 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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1. What Tranexamic acid 500 mg Tablets are and what
they are used for
2. 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. Further Information

1

Take special care with 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.

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

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.

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
• Any other medicine, including medicines obtained without
a prescription.

Before you take Tranexamic acid
500 mg Tablets

Do not take Tranexamic acid 500 mg Tablets if you:
• are allergic to tranexamic acid or any of the other
ingredients of these tablets (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.

Pregnancy and breast-feeding
If you are pregnant, think you might be pregnant or are
breast-feeding ask your doctor for advice before taking any
medicine.

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

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

Continued on the next page >>

Artwork Proof Box
Ref: N031 - Add FAMAR and associated process changes
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Date prepared:
22/05/2014

Colours:
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Dimensions: 148 x 210 mm

Font size:
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Fonts:
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3

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

How to take Tranexamic acid 500 mg
Tablets

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

Always take Tranexamic acid 500 mg Tablets as your doctor
has told you.

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.

Nervous System Disorders
Very rare (affects less than 1 user in 10,000)
• Fits (convulsions).

The usual 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.

5

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.

How to store Tranexamic acid 500 mg
Tablets

Keep out of the reach and sight of children.
Do not use Tranexamic acid 500 mg Tablets 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.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.

6

Further 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.

Possible side effects

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.

Like all medicines, Tranexamic acid 500 mg Tablets 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

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.

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.

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.

Vascular disorders
Rare (affects 1 to 10 users in 1,000)
• A blood clot in your blood vessels (called a `thrombosis’).

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mat.no.: 00000000

Skin and subcutaneous tissue disorders
Rare (affects 1 to 10 users in 1,000)
• Itchy, red or swollen skin.

If any of these side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

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

4

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.

This leaflet was last revised in 05/2014.

Artwork Proof Box
Ref: N031 - Add FAMAR and associated process changes
Proof no.
011.0

Date prepared:
22/05/2014

Colours:
Black
Dimensions: 148 x 210 mm

Font size:
6.5pt
Fonts:
Helvetica

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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