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TRANEXAMIC ACID TILLOMED 500 MG FILM-COATED TABLETS

Active substance(s): TRANEXAMIC ACID

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If you take more Tranexamic acid Tillomed 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 Tillomed
500 mg film-coated tablets may make you feel
sick, be sick or be dizzy or light-headed upon
standing.

Ÿ Keep this leaflet. You may need to read it again.
Ÿ If you have any further questions, ask your
doctor or pharmacist.

Ÿ 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.
Ÿ 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:

4
5
6

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

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4 Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately if:
Ÿ you get a rash or allergic reaction such as
i t c h i n g,
swollen
lips/tongue
or
wheezing/shortness of breath, stop taking the
capsules straight away and tell your doctor
immediately
Ÿ 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

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines
Ÿ Fibrinolytic drugs (used to help dissolve blood
clots), such as streptokinase. This is because
Tranexamic acid Tillomed 500 mg film-coated
tablets will stop these drugs working
Ÿ Oral contraceptives. These may increase the
risk of blood clots forming
Ÿ Any other medicine, including medicines
obtained without a prescription.

1 What Tranexamic acid Tillomed 500 mg

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

Pregnancy, breast-feeding and fertility

film-coated tablets are and what it is
used for

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 Tillomed 500 mg filmcoated tablets.

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.

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If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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 Tillomed 500 mg
film-coated tablets

Tranexamic acid Tillomed 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:
Ÿ Following prostate surgery (postprostatectomy)
Ÿ Following bladder surgery
Ÿ Heavy periods (menorrhagia)
Ÿ Severe Nose bleeds (Severe epistaxis)
Ÿ Cervical surgery (conisation of the cervix)
Ÿ To prevent repeated bleeding inside the eye
(Prevention of recurrent hemorrhage in
traumatic hyphaema)
Ÿ Tooth removal (dental extraction) in
haemophiliacs (people who bleed more easily
than normal). You will know if this refers to you
Ÿ A hereditary disease called angioneurotic
oedema (HANO). A doctor will have told you if
you have this.

Tranexamic acid Tillomed 500 mg film-coated
tablets contain castor oil
Tranexamic acid Tillomed 500 mg film-coated
tablets contain castor oil. This can cause stomach
upset and diarrhoea.
3 How to take Tranexamic acid Tillomed

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.

2 What you need to know before you

take Tranexamic acid Tillomed 500 mg
film- coated tablets

Remember: Your medicine should always be taken
with a glass of water. The tablets should be
swallowed whole. Do not crush or chew them.

Do not take Tranexamic acid Tillomed 500 mg
film-coated tablets if

Use in adults and elderly
Ÿ The usual dose is 2 or 3 tablets taken t wo to
three times daily
Ÿ The exact dose you take will depend on why
you have been prescribed these tablets
Ÿ 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.

Ÿ You are allergic to tranexamic acid or any of the
other ingredients in this medicine (listed in
section 6)
Ÿ You have serious problems with your kidneys
(kidney failure)
Ÿ You have or have ever had a blood clot in your
blood vessels (called a 'thrombosis').
Ÿ You have a history of convulsions
Ÿ 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.

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3

If you forget to take Tranexamic acid Tillomed
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.

Other medicines and Tranexamic acid Tillomed
500 mg film-coated tablets

1 What Tranexamic acid Tillomed 500 mg

2

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Ÿ You have blood in your urine
Ÿ You have ever had any uncontrollable bleeding
Ÿ You have disseminated intravascular
coagulation (DIC), a disease where your blood
starts to clot throughout your body
Ÿ 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
Ÿ You are a woman with irregular periods
Ÿ You or your family have a history of blood clots
in your blood vessels (called a 'thrombosis')
Ÿ Anyone in your family has suffered from blood
clots in their blood vessels
Ÿ You have kidney disease.

Read all of this leaflet carefully before you start
using this medicine because it contains
important information for you.

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 diarhoea are usually mild
and pass very quickly, but if they continue, tell your
doctor or pharmacist.

6 Contents of the pack and other

information
What Tranexamic acid Tillomed 500 mg filmcoated 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
hy d ro g e n a t e d, m a g n e s i u m s t e a r at e,
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 Tillomed 500 mg filmcoated tablets looks like and contents of the
pack
Tranexamic acid Tillomed tablets are off white to
pale yellow, oval shaped film-coated tablet plain
on both sides.
Tranexamic acid Tillomed 500 mg film-coated
tablets are supplied in:
Blister packs (OPA/Alu/PVC) containing 10, 60 and
100 tablets.
HDPE (High density polyethylene) bottles
containing 100 tablets.
Not all pack sizes are marketed.
M a r ke t i n g Au t h o r i s a t i o n H o l d e r a n d
Manufacturer
Marketing Authorisation Holder
Tillomed laboratories Ltd,
3 Howard Road,
Eaton Socon, St Neots
Cambridgeshire
PE19 8ET
United Kingdom
Manufacturer1
Emcure Pharma UK Ltd,
Devonshire House
582 Honeypot Lane
Stanmore, HA7 1JS
United Kingdom
Tillomed laboratories Ltd
3 Howard Road,
Eaton Socon, St Neots
Cambridgeshire
PE19 8ET
United Kingdom
1Only the actual release site will be listed on the

marketed product
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 Tillomed

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 is authorised in the
Member States of the EEA under the following
names:
United Kingdom Tranexamic Acid Tillomed
500 mg film-coated tablets
Austria
Tr a n e x a m s ä u re T i l l o m e d
500 mg Filmtabletten
Germany
Tranexamic Acid Tillomed
500 mg Filmtabletten
Spain
Acido tranexamico Tillomed
500 mg comprimidos
recubiertos con pelicula EFG
Italy
Acido Tranexamico Tillomed
Netherlands
Tranexaminezuur Tillomed
500 mg filmomhulde tabletten
Poland
Tranexamic Acid Tillomed
This leaflet was last approved on 03/2016

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.

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.

Warnings and precautions
Talk to your doctor or pharmacist before taking
Tranexamic acid Tillomed 500 mg film-coated
tablets if.
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V2G
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Package Leaflet: Information for the User

Tranexamic acid Tillomed 500 mg film-coated tablets
tranexamic acid

65 mm

510008282GB01

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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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