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TRANEXAMIC ACID 500MG TABLETS

Active substance(s): TRANEXAMIC ACID / TRANEXAMIC ACID / TRANEXAMIC ACID

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PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

Tranexamic Acid 500mg 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 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 is and what it is used for
2. What you need to know before you take
Tranexamic Acid
3. How to take Tranexamic Acid
4. Possible side effects
5. How to store Tranexamic Acid
6. Contents of the pack and other information

1. What Tranexamic Acid is and what it is
used for
Tranexamic Acid 500mg Tablets (hereinafter referred
to as Tranexamic Acid) are an antifibrinolytic agent
used to reduce bleeding. When you bleed your body
forms clots or plugs as part of healing. In some
people these plugs do not stay in place long enough.
This can cause too much bleeding. Tranexamic acid
helps these plugs to stay in place.
Tranexamic acid can be used to prevent or reduce
bleeding for a short period of time in many different
conditions. You could have been prescribed this
medicine for one of the following reasons:
following prostate surgery
heavy periods
nose bleeds
surgery to the cervix in women
bleeding inside the eye
tooth removal in haemophiliacs
a hereditary disease called angioneurotic oedema
(HANO).

2. What you need to know before you take
Tranexamic Acid
Do not take Tranexamic Acid if you have or have
had:
an allergic (hypersensitive) reaction to Tranexamic
Acid or any of the other ingredients of Tranexamic
Acid Tablets (see section 6 for other ingredients)

a blood clot, for example in your leg or lungs
kidney failure
fits
any condition which has caused you to have a
blood clot or means that you are at risk of
developing a blood clot.
Warnings and precautions
Tell your doctor if you have or have had:
kidney disease
blood in your urine
any uncontrollable bleeding including menstrual
bleeding
If you take this medicine for hereditary angioneurotic
oedema your doctor may arrange for you to have
regular blood tests to check that your liver is working
properly and may suggest that you have regular eye
tests.
Children under 15 years of age with heavy menstrual
bleeding should consult their doctor before use.
Other medicines and Tranexamic Acid
Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.
You must tell your doctor or pharmacist if you are
already taking any of the following medicines:
fibrinolytics, drugs which help to dissolve blood
clots, such as streptokinase
medicines that may affect the ability of your blood
to clot, or that may increase the risk of clots
forming, such as oestrogens which may be
present in some oral contraceptives and some
hormone replacement therapies.
Taking Tranexamic Acid with food and drink
The tablets should be taken with a glass of water.
The tablets should be swallowed whole. Do not crush
or chew them.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Tranexamic Acid should not have an effect on your
ability to drive or use machinery.

3. How to take Tranexamic Acid
Always take this medicine exactly as described in this
leaflet or as your doctor has told you. You should
check with your doctor or pharmacist if you are not
sure.
(continued overleaf)

Adults
The usual adult dose is 2-3 tablets two-three times
daily. However, your doctor may have prescribed you
a different dose. If you are taking this medicine for
heavy periods, do not take more than 4g daily (8
tablets). The dose will be reduced if you have kidney
disease.
Children
The child dose is worked out according to the
patient's body weight.
Your doctor will tell you how long you will need to
take this medicine for, as this will depend on your
condition.
If you take more Tranexamic Acid than you should
As with all medicines an overdose of this medicine
could be dangerous. If you have taken an overdose
tell your doctor or go to the nearest hospital casualty
department immediately.
Taking too much Tranexamic Acid may make you feel
sick, be sick or be dizzy or lightheaded upon standing.
If you forget to take Tranexamic Acid
If you forget to take your tablets you should take your
next dose as usual. Do not take a double dose to
make up for the forgotten dose.
If you have any further questions on the use of this
product ask your doctor or pharmacist.

4. Possible side effects
Like all medicines Tranexamic Acid can cause side
effects, although not everybody gets them.
If you experience the following rare side effects stop
taking this medicine immediately and speak to your
doctor:
colour vision disturbance
changes in your eyesight
Rare side effects
a blood clot in your eye which may cause bleeding
in the eye, or a loss of vision
itchy, red or swollen skin (allergic reaction)
Very rare side effects
allergic reactions which cause difficulty in
breathing or dizziness
nausea, sickness or diarrhoea. Reducing the dose
may prevent these symptoms
a blood clot in your blood vessels (thrombosis)
Frequency not known
fits
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.
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.
By reporting side effects you can help
provide more information on the safety of
this medicine.

5. How to store Tranexamic Acid
Keep medicines out of the sight and reach
of children. This product should not be
used after the expiry date which appears on the
carton and blister strips.
Do not store above 25°C.
Store in the original carton.
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. Contents of the pack and other
information

What Tranexamic Acid contains
Each tablet contains 500mg of tranexamic acid. The
tablet core also contains microcrystalline cellulose,
povidone, croscarmellose sodium, colloidal
anhydrous silica, talc and magnesium stearate. The
tablets are coated with a film coat containing
methacrylate polymers, titanium dioxide (E171), talc,
magnesium stearate and macrogol 8000.
What Tranexamic Acid looks like and contents of
the pack
The tablets are white to off-white and capsule
shaped. They are engraved with "TA 500" on one
side, and have a central division line on the other
side.
They are supplied in cartons containing 60 tablets.
Marketing Authorisation Holder:
Manx Healthcare Ltd, Taylor Group House
Wedgnock Lane, Warwick, CV34 5YA,
United Kingdom.
Distributor:
Creo Pharma Ltd, Felsted Business Centre,
Felsted, Essex, CM6 3LY, United Kingdom.
Manufacturer:
Manx Healthcare Ltd, Taylor Group House,
Wedgnock Lane, Warwick, CV34 5YA,
United Kingdom.
Other Formats
To request a copy of this leaflet in Braille, large print
or audio please call 01926 482511.
This leaflet was last revised in
March 2017.
WIP URN: 080317-GT07C-PIL-03

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

080317-GT07C-PIL-03
Tranexamoc Acid Creo PIL
210 x 140mm
8 March 2017
14212_03 PIL.ai
1 Colour - Black

M1X

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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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