Tranexamic acid 500mg tablets

Main information

  • Trade name:
  • Tranexamic acid 500mg tablets
  • Dosage:
  • 500mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Tranexamic acid 500mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02110000

Status

  • Source:
  • eMC
  • Last update:
  • 29-01-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER

Tranexamic Acid 500mg Tablets

TRANEXAMIC ACID

(continued overleaf)

WIP URN

080317-GT07C-PIL-03

APPROVED URN

Job

Tranexamoc Acid Creo PIL

Size

210 x 140mm

Date

8 March 2017

BOH Approval Date

Saved as

14212_03 PIL.ai M1X

Prints

1 Colour - Black

WIP URN: 080317-GT07C-PIL-03

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.

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.