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TRANEXAMIC ACID 500 MG TABLETS

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Patient Information Leaflet

000-0000

Tranexamic Acid 500 mg Tablets
SAMPLE PHARMACODE

Tranexamic Acid

Read all of this leaflet
carefully before you
start taking this medicine.
• Please 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 becomes severe, 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. WHAT TRANEXAMIC ACID 500 MG TABLETS
ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Tranexamic Acid 500 mg
Tablets. The active ingredient is tranexamic acid.
Tranexamic acid belongs to a group of medicines known
as anti-fibrinolytics which is used to prevent or reduce
bleeding. When you bleed (through injury) your body
forms clots as part of the healing process. In some people
these blood clots do not stay in place long enough,
causing too much bleeding to occur. Tranexamic acid
helps these clots to stay in place.
You may have been prescribed this medicine for one or
more of the following conditions:
• following prostate surgery (prostatectomy) or
bladder surgery;
• heavy periods (menorrhagia);
• nose bleeds (epistaxis);
• cervical surgery;
• bleeding in the eye (traumatic hyphaema);
• tooth removal in haemophiliacs (people with
inherited blood clotting disorder);
• hereditary angioedema (a doctor would have told
you if you have this condition).

JOB NO:
Originator:

2. 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 (please refer to section 6, further
informationforthefulllistofingredients)ofthismedicine
(allergicreactionsincludemildsymptomssuchasitching
and/or rash. More severe symptoms include swelling
of the face, lips, tongue and/or throat with difficulty in
swallowing or breathing);
• you have active thromboembolic disease (blood clots,
e.g. in your leg or lungs);
• you have severe kidney disease.
Take special care with this medicine and tell your
doctor or pharmacist if:
• you have blood in your urine;
• you have ever had any uncontrolled bleeding;
• you have a history or family history of thromboembolic
disease (if you have ever had a blood clot e.g. in your
legs or lungs);
• you have been taking this medication every day for a
long time. If so, you may need to have regular eye
tests and blood tests to check your liver;
• you have kidney disease;
• you have irregular menstrual bleeding.
Taking other medicines
Tell your doctor if you are taking any other medicines,
especially the following:
• medicines known as fibrinolytics which stop your
body making blood clots.
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
Pregnancy and breast feeding
Tell your doctor or pharmacist if you become pregnant, or
if you are breast-feeding.
Driving and using machines
This medicine is not expected to interfere with your
ability to drive or use machines.
3. HOW TO TAKE TRANEXAMIC ACID 500 MG TABLETS
Always take your medicine exactly as your doctor has told
you. You should check with your doctor or pharmacist if
you are not sure. He or she will tell you how many tablets
to take and how often to take them.

Adults
The dosage that will be prescribed depends on your
condition. The usual dosages are:
• following prostate or bladder surgery: two tablets,
three to four times daily, until blood is no longer
present in the urine;
• heavy periods: 2-3 tablets, three times daily for
up to four days, after heavy bleeding has started. If
menstrual bleeding is very heavy the dosage may
be increased;
a total of 4 gm daily (eight tablets) should not be
exceeded;
• nose bleeds: where bleeding is expected to recur,
two tablets, three times daily for seven days;
• cervical surgery: three tablets three times daily;
• bleeding in the eyes: 2-3 tablets three times daily;
• tooth removal in haemophiliacs: 2-3 tablets every
eight hours;
• hereditary angioedema: 2-3 tablets two to three times
daily. This may be for some days or continuously.

Tell your doctor immediately if you have colour
vision disturbance, which can occur rarely. Your doctor
should withdraw treatment.
Other side effects may include:
Rarely, cases of thromboembolic events (movement
of blood clots through the bloodstream) have occurred.
Rarely some people may get an allergic skin reaction
(this may include mild symptoms such as itching and/or
rash. More severe symptoms include swelling of the face,
lips, tongue and/or throat with difficulty in swallowing
or breathing).
If any of the side effects becomes severe, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist immediately.

Also you can help to make sure that medicines remain
as safe as possible by reporting any unwanted side
effects via the internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352
Children
Ifthetabletsareforachild,yourdoctorwillworkoutthedose (available from 10 a.m. to 2 p.m. Mondays to Fridays)
depending on the child’s body weight at 25 mg/kg per dose. or fill in a paper form available from your local
pharmacy.
If you have kidney problems
Youmaybeprescribedalowerdoseifyouhavekidneydisease. 5. HOW TO STORE TRANEXAMIC ACID 500 MG
TABLETS
The tablets should be taken with water.
Do not store above 25°C. Keep the container tightly closed
and store in the original container. Do not use after the
If you take more Tranexamic Acid 500 mg Tablets expiry date that is stated on the carton.
than you should
If you accidentally take too much of your medicine, tell KEEP ALL MEDICINES OUT OF THE SIGHT AND
your doctor at once or contact your nearest hospital
casualty department. Take your medicine and this REACH OF CHILDREN.
leaflet with you.
Return any unused medicine to your pharmacist.
If you forget to take your tablets
If you forget to take a dose, just take the next dose at 6. FURTHER INFORMATION
What Tranexamic Acid 500 mg Tablets contain
the usual time. DO NOT take a double dose.
Each tablet contains 500 mg of the active substance,
tranexamic acid. The other ingredients are: microcrystalline
4. POSSIBLE SIDE EFFECTS
Like all medicines tranexamic acid can cause unwanted cellulose, povidone K90, croscarmellose sodium, colloidal
side effects in some people, although it is generally well anhydrous silica, talc, magnesium stearate, methacrylate
tolerated. You are unlikely to get any of the following, but polymers, titanium dioxide (E171), macrogol 8000
if you do, tell your doctor immediately:
and vanillin.
• nausea;
• vomiting;
What Tranexamic Acid 500 mg Tablets look like and
• diarrhoea.
the contents of the pack
If you notice any side effects mentioned above, please Tranexamic Acid 500 mg Tablets are white to off-white,
oblong and biconvex with a breakline and marked “TA” on
tell your doctor or pharmacist.
one side of the breakline. They are available in packs of
12 and 60 tablets.

FINISHED SIZE 148 x 210

Marketing Authorisation Holder:
Waymade Plc trading as Sovereign Medical, Sovereign
House, Miles Gray Road, Basildon, Essex SS14 3FR,
United Kingdom.
This leaflet was last revised in April 2013

Colours Used: BLK

ARTWORK SCALE 100%

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Signature.............................................................................
Name....................................................................................
Date......................................................................................

PRODUCT NAME: Tranexamic Acid 500 mg Tablets

D. T.

Date: 17.04.13

REGULATORY AUTHORITY APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by the
appropriate market authority (if applicable, e.g. MHRA, IMB,
etc and that Amdipharm have license approval to distribute
this component for sale in the relevent market.

COMPONENT: PIL
PIP CODE:

FONT SIZE 11pt PC 216

000-0000

VERSION: 1

WAYMADE PLC
IN HOUSE LEAFLET
PROOF

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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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