Tranexamic Acid 500mg Tablets
PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER
PATIENT INFORMATION LEAFLET - INFORMATION FOR THE USER
1. What Tranexamic Acid is and what it is used for
2. Before you take Tranexamic Acid
Tranexamic Acid 500mg Tablets
TRANEXAMIC ACID
3. How to take Tranexamic Acid
4. Possible side effects
5. How to store Tranexamic Acid
Read all of this leaflet carefully before you start taking this medicine.
■ Keep this leaflet. You may need to read it again.
I 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 get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Tranexamic Acid is and what it is used for
2. Before you take Tranexamic Acid
3. How to take Tranexamic Acid
4. Possible side effects
5. How to store Tranexamic Acid
6. Further information
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).
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.
Take special care and 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.
Taking other medicines
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.
Always take Tranexamic Acid exactly 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.
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.
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
■ nausea, sickness or diarrhoea. Reducing the dose may prevent these symptoms
■ 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)
■ a blood clot in your blood vessels (thrombosis) or kidney (leading to renal problems)
■ fits
■ low blood pressure that may make you faint or feel dizzy.
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 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.
Keep medicines out of the reach and sight 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. Further 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:
Teva UK Ltd, Eastbourne, BN22 9AG 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 September 2013
WIP URN: 090913-GT07RT-PIL-05
ET7W71
84069-B
(continued overleaf)
Tranexamic Acid 500mg Tablets
TRANEXAMIC ACID
■ 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.
Take special care and 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. Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
L
_ ead all of this leaflet carefully before
^ou start taking this medicine.
fKeep this leaflet. You may need to read again.
I If you have any further questions, ask _ your doctor or pharmacist, p 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 get serious, or if you Inotice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
h. What Tranexamic Acid is and what it is used for
2. Before you take Tranexamic Acid
b. How to take Tranexamic Acid
A. Possible side effects
b. How to store Tranexamic Acid
6. Further information
Tranexamic Acid 500mg Tablets (hereinafter referred ito 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. iTranexamic 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
Lmedicine for one of the following reasons: following prostate surgery p heavy periods ■ nose bleeds
^ surgery to the cervix in women ■ bleeding inside the eye h tooth removal in haemophiliacs
ra hereditary disease called angioneurotic oedema (HANO).
I 2. Before you take Tranexamic Acid
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
|Do not take Tranexamic Acid if you have or have had:
h an allergic (hypersensitive) reaction to Tranexamic Acid or any of the other ingredients of Tranexamic I Acid Tablets (see section 6 for other ingredients) p a blood clot, for example in your leg or lungs
Always take Tranexamic Acid exactly as your doctor | has told you. You should check with your doctor or pharmacist if you are not sure.
(continued overleaf)
SIZE: 210X140 (mm) Front Dt. 21/01/06
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.
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
■ nausea, sickness or diarrhoea. Reducing the dose may prevent these symptoms
■ 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)
■ a blood clot in your blood vessels (thrombosis) or kidney (leading to renal problems)
■ fits
■ low blood pressure that may make you faint or feel dizzy.
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.
10 877 0 602291
By reporting side effects you can help provide more information on the safety of this medicine. -
Keep medicines out of the reach and sight 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.
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:
Teva UK Ltd, Eastbourne, BN22 9AG.
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 September 2013
WIP URN: 060913-GT07T-PIL-04
SIZE: 210X140 (mm) Back Dt.: 21/01/06