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TRANEXAMIC ACID TILLOMED 500 MG FILM-COATED TABLETS

Active substance(s): TRANEXAMIC ACID / 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 using 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, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Tranexamic acid 500 mg film-coated tablets are and what it is used for
What you need to know before you use Tranexamic acid 500 mg film-coated tablets
How to use Tranexamic acid 500 mg film-coated tablets
Possible side effects
How to store Tranexamic acid 500 mg film-coated tablets
Contents of the pack and other information

1.

What Tranexamic acid 500 mg film-coated tablets are and what it is 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 500 mg film-coated tablets are 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)
• Severe Nose bleeds (Severe epistaxis)
• Cervical surgery (conisation of the cervix)
• To prevent repeated bleeding inside the eye (Prevention of recurrent hemorrhage in 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 500 mg film-coated tablets

Do not take Tranexamic acid 500 mg film-coated tablets if
• You are allergic to tranexamic acid or any of the other ingredients in this medicine (listed in
section 6)
• You have serious problems with your kidneys (kidney failure)
• You have or have ever had a blood clot in your blood vessels (called a `thrombosis’).
• You have a history of convulsions
• You are at risk of excessive bleeding as a result of a bleeding disorder called consumption
coagulopathy.
If any of the above applies to you talk to your doctor or pharmacist.
Warnings and precautions

Talk to your doctor or pharmacist before taking Tranexamic acid 500 mg film-coated tablets if.
• You have blood in your urine
• You have ever had any uncontrollable bleeding
• You have disseminated intravascular coagulation (DIC), a disease where your blood starts to
clot throughout your body
• 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
• You are a woman with irregular periods
• You or your family have a history of blood clots in your blood vessels (called a `thrombosis’)
• Anyone in your family has suffered from blood clots in their blood vessels
• You have kidney disease.
Other medicines and Tranexamic acid 500 mg film-coated tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines
• Fibrinolytic drugs (used to help dissolve blood clots), such as streptokinase. This is because
Tranexamic acid 500 mg film-coated tablets will stop these drugs working
• Oral contraceptives. These may increase the risk of blood clots forming
• Any other medicine, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking Tranexamic acid 500 mg film-coated tablets.
Tranexamic Acid is excreted into breast milk although the amount is minimal. If you are breastfeeding
talk to your doctor or pharmacist before taking Tranexamic acid 500 mg film-coated tablets
Tranexamic acid 500 mg film-coated tablets contain castor oil
Tranexamic acid 500 mg film-coated tablets contain castor oil. This can cause stomach upset and
diarrhoea.
3.

How to take Tranexamic acid 500 mg film-coated tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
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.
Use in adults and 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
• 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 500 mg film-coated tablets than you should
If you accidentally take too much of your medicine, immediately tell your doctor or go to the nearest
hospital
Taking too much Tranexamic acid 500 mg film-coated tablets may make you feel sick, be sick or be
dizzy or light-headed upon standing.
If you forget to take Tranexamic acid 500 mg film-coated tablets
Do not take a double dose to make up for a missed dose. Simply take the next dose as planned.
If you have any further questions on 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.
Tell your doctor immediately if:



you get a rash or allergic reaction such as itching, swollen lips/tongue or wheezing/shortness of
breath, stop taking the capsules straight away and tell your doctor immediately
you have blood clots in the veins (an rare side effect that may affect up to 1 in 1000 people)
especially in the legs (symptoms include swelling, pain, and redness in the leg), which may
travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you
notice any of these symptoms seek medical advice immediately

Rare (affects 1 to 10 users in 1,000)
– 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
– itchy, red or swollen skin
Very rare (affects less than 1 user in 10,000)
– a blood clot in your blood vessels (called a `thrombosis’).
– allergic reactions which may cause difficulty in breathing or dizziness.
– feeling sick (nausea)
– being sick (vomiting)
– diarrhoea
– fits or seizures (Convulsions)
– a general feeling of illness (Malaise) with low blood pressure (hypotension) with or without loss of
consciousness
Nausea, vomiting and diarrhoea are usually mild and pass very quickly, but if they continue, tell your
doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the national reporting
system listed in 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 500 mg film-coated 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 label. The expiry date refers to the
last day of that month.
This medicinal product does not require any special storage conditions.
Use within 25 days after first opening the HDPE bottle.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help to protect the environment.
6.

Contents of the pack and other information

What Tranexamic acid 500 mg film-coated tablets contain
The active substance is Tranexamic acid. Each tablet contains 500 mg Tranexamic acid.
The other ingredients are cellulose microcrystalline, starch pregelatinised, low substituted
hydroxypropyl cellulose, silica colloidal anhydrous, povidone, Talc, castor oil hydrogenated,
magnesium stearate, hypromellose, titanium dioxide, macrogol, propylene glycol, sodium lauryl
sulfate.
This medicine contains 5.50% w/w, propylene glycol as an ingredient necessary for the medicine to
work properly.
What Tranexamic acid 500 mg film-coated tablets looks like and contents of the pack
Tranexamic acid tablets are off white to pale yellow, oval shaped film-coated tablet plain on both
sides.
Tranexamic acid 500 mg film-coated tablets are supplied in:
Blister packs (OPA/Alu/PVC) containing 10, 20, 30, 50, 60 and 100 tablets.
HDPE (High density polyethylene) bottles containing 100 tablets.
Not all pack sizes are marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Laboratories Ltd,
3 Howard Road,
Eaton Socon, St Neots
Cambridgeshire
PE19 8ET
United Kingdom
Manufacturer 1
Emcure Pharma UK Ltd,
Basepoint Business Centre
110 Butterfield, Great Marlings
Luton, LU2 8DL
United Kingdom
Tillomed Laboratories Ltd
3 Howard Road,
Eaton Socon, St Neots
Cambridgeshire
PE19 8ET
United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following
names:
United Kingdom
Austria
Germany
Spain
1

Tranexamic Acid 500 mg film-coated tablets
Tranexamsäure Tillomed 500 mg Filmtabletten
Tranexamsäure Tillomed 500 mg Filmtabletten
Acido tranexamico Tillomed 500 mg comprimidos recubiertos con película EFG

Only the actual release site will be listed on the marketed product

Italy
Netherlands
Poland

Acido Tranexamico Tillomed
Tranexaminezuur Tillomed 500 mg filmomhulde tabletten
Tranexamic Acid Tillomed

This leaflet was last approved on 09/2016

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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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