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TRANEXAMIC ACID 500 MG FILM COATED TABLETS

Active substance(s): TRANEXAMIC ACID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Tranexamic Acid

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

1. WHAT TRANEXAMIC ACID
TABLETS ARE AND WHAT
THEY ARE USED FOR

Tranexamic Acid belongs 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 stops these clots
dissolving and so reduces unwanted bleeding.
Tranexamic Acid is 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 TABLETS

Do not take Tranexamic Acid Tablets:
• if you are allergic to tranexamic acid or any
of the other ingredients of this medicine
(listed in section 6)
• if you have serious problems with your
kidneys (kidney failure)
• if you have a blood clot in your blood vessels
(called a `thrombosis’)

• if you have a history of blood clots in your
blood vessels (called a `thrombosis’)
• if you have disseminated intravascular
coagulation (DIC), a disease where your
blood starts to clot throughout your body
• if you have a history of fit
If any of the above applies to you, talk to your
doctor or pharmacist.
Warning and precautions
Talk to your doctor before taking
Tranexamic Acid Tablets:
• if you have blood in your urine
• if you have ever had any uncontrollable bleeding
• if you have disseminated intravascular
coagulation (DIC), a disease where your
blood starts to clot throughout your body
• if 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
• if you are a woman with irregular periods
• if you have a history of blood clots in your
blood vessels (called a `thrombosis’)
• if anyone in your family has suffered from
blood clots in their blood vessels
• if you have kidney disease.
• if you have been taking oral contraceptives
Other medicines and Tranexamic Acid Tablets
Tell your doctor if you are taking, have
recently taken or might take any other
medicines, including medicines obtained
without a prescription.
You should specifically tell your doctor if you take:
• Fibrinolytic drugs (used to help dissolve blood
clots), such as streptokinase. This is because
Tranexamic Acid will stop these drugs working
Pregnancy and breast-feeding and fertility
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.

3. HOW TO TAKE
TRANEXAMIC ACID TABLETS

Always take this medicine exactly 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.
Remember: Your medicine should always be taken
with a glass of water. The tablets should be
swallowed whole. Do not crush or chew them.
Adults and the elderly:
• 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
continued over

• Follow your doctor’s instructions about how
many tablets to take, when to take them and
for how long.
Use in 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 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.
Taking too many Tranexamic Acid Tablets may
make you feel sick, be sick or be dizzy or
light-headed upon standing.
If you forget to take Tranexamic Acid 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 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.
Stop taking this medicine and go
immediately to the hospital if you
experience any of the following rare
symptoms:
• pain or feeling of heaviness in your chest;
• sudden short of breath;
• coughing up blood;
• unusual pain or swelling in your arms or legs;
• fainting.
You may have developed a blood clot in your
leg or lungs
Stop taking this medicine and tell your doctor
immediately if you experience any of the
following rare symptoms:
• 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;
• an allergic skin reaction (mild symptoms
include itching and/or rash; more severe
symptoms include swelling of the face, lips,
tongue and/or throat with difficulty in
swallowing or breathing).
Other side effects include:
• Feeling sick
• Being sick
• Diarrhoea
These are usually mild and pass very quickly,
but if they continue, tell your doctor or
pharmacist.
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.

Reporting of side effects
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
reportside 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 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 carton. The
expiry date refers to the last day of that month.
Do not store above 30 °C. Store in the original
package. Do not throw away any medicines via
wastewater or house hold waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.

6. CONTENT OF PACK
AND OTHER INFORMATION

What Tranexamic Acid Tablets contains:
• The active substance is tranexamic acid.
Each film-coated tablet contains 500 mg
tranexamic acid.The other ingredients are:
• Tablet core: Cellulose microcrystalline,
povidone (K 90), croscarmellose sodium, silica
colloidal anhydrous, talc, magnesium stearate;

Film coating: methacrylate polymers, titanium
dioxide (E171), talc, magnesium stearate,
macrogol (8000).
What Tranexamic Acid Tablets looks like and
contents of the pack
Tranexamic Acid tablets are white to off white,
capsule shaped, biconvex film-coated tablets. They
are marked with TXA 500 with a break line.
The tablets come in blister packs containing 60
tablets.
Marketing authorisation holder
Rivopharm UK Ltd.
30th Floor, 40 Bank Street,
Canary Wharf,
London E14 5NR
Manufacturers
Laboratories BTT
ZI de Krafft
67150 Erstein
France
Rivopharm UK Ltd.
30th Floor, 40 Bank Street,
Canary Wharf,
London E14 5NR
United Kingdom
This leaflet was last approved in 1/2016

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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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