Tranexamic Acid 500mg Tablets
Patient Information Leaflet 797-9180
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);
• nosebleeds (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).
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 information for the lull list of ingredients) of this medicine (allergic reactions 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 breaming);
• 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. HOWTO 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.
Children
If the tablets are for a child, your doctor will work out the dose depending on the child's body weight at 25 mg/kg per dose.
If you have kidney problems
You may be prescribed a lower dose if you have kidney disease.
The tablets should be taken with water.
you take more Tranexamic Acid 500 mg Tablets than you should
I you accidentally take too much of your medicine, tell your doctor at once or contact your nearest hospital casualty department. Take your medicine and this leaflet with you.
you forget to take your tablets
I you forget to take a dose, just take the next dose at the usual time. DO NOT take a double dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines tranexamic acid can cause unwanted side effects in some people, although it is generally well tolerated. You are unlikely to get any of thefollowing, but if you do, tell your doctor immediately:
• nausea;
• vomiting;
• diarrhoea.
If you notice any side effects mentioned above, please tell your doctor or pharmacist.
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 anyside effects not listed in this leaflet, please tell your doctor or pharmacist immediately
5. HOW TO STORE TRANEXAMIC ACID 500 MG TABLETS
Do not store above 25°C. Keep the container tightly closed and store in the original container. Do not use after the expiry date that is stated on the carton.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Return any unused medicine to your pharmacist.
6. FURTHER INFORMATION
What Tranexamic Acid 500 mg Tablets contain
Each tablet contains 500 mg of the active substance, tranexamic acid. The other ingredients are: microcrystalline cellulose, povidone K90, croscarmellose sodium, colloidal anhydrous silica, talc, magnesium stearate, methacrylate polymers, titanium dioxide (El71), macrogol 8000 and vanillin.
What Tranexamic Add 500 mg Tablets look like and the contents of the pack
Tranexamic Acid 500 mg Tablets are white to off-white, oblong and biconvex with a breakline and marked "TA" on one side of the breakline. They are available in packs of 12 and 60 tablets.
Marketing Authorisation Holder:
Waymade Pic trading as Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex SSI4 3FR, United Kingdom.
This leaflet was last revised in April 2011