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TRANEXAMIC ACID 500MG/5ML SOLUTION FOR INJECTION

Active substance(s): TRANEXAMIC ACID

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149 mm

149 mm

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BACK
12mm

12mm

3. How Tranexamic
Injection is given

Package leaflet: information for the patient

Tranexamic Acid 500mg/5ml Solution for Injection

• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or nurse.
• If you get any side effects, talk to your doctor
or nurse. This includes any possible side
effects not listed in this leaflet.

What is in this leaflet:

1. What Tranexamic Acid Solution for Injection is
and what it is used for
2. What you need to know before you are given
Tranexamic Acid Solution for Injection
3. How Tranexamic Acid Solution for Injection is
given
4. Possible side effects
5. How to store Tranexamic Acid Solution for
Injection
6. Contents of the pack and other information

Tranexamic Acid 500mg/5ml Solution for Injection
(called Tranexamic Acid Solution for Injection
throughout the rest of this leaflet) contains
tranexamic acid which belongs to a group of
medicines called antihaemorragics; antifibrinolytics,
aminoacids. Tranexamic acid is used in adults and
children above one year of age for the prevention
and treatment of bleeding due to a process that
inhibits blood clotting called fibrinolysis.
Specific uses include:
• heavy periods in women;
• gastrointestinal bleeding;
• haemorrhagic urinary disorders after having an
operation on your prostate gland or urinary
tract;
• after having an operation on your ear, nose or
throat;
• after having heart, abdominal or gynaecological
surgery;
• bleeding after you have been treated with
another medicine to break down blood clots.

2. What you need to know before you are
given Tranexamic Acid Solution for Injection

Do not have Tranexamic Acid Solution for
Injection if you:
• are allergic (hypersensitive) to tranexamic
acid or any of the other ingredients of this
medicine (see section 6, Other information);
• currently have or have ever had a disease
leading to blood clots;
• have a condition called “consumption
coagulopathy” where blood in the whole
body starts to clot;

for

Tranexamic Acid Solution for Injection will be
given to you by a slow injection into your vein.
Your doctor will decide the correct dose for you
and how long you should take it.
Use in Adults
• Treatment of Local Fibrinolysis:
The usual dose is 500-1000mg (5-10ml) three
times a day. This will usually be given by a
slow injection into your vein.
• Treatment of General Fibrinolysis:
The usual dose is 1000mg (10ml) every 6 to 8
hours, or up to 15mg per kg of body weight.
Use in Children
• The doctor will decide the right dose to give your
child and how long he or she should take it.
• If Tranexamic Acid Solution for Injection is
given to a child over one year old, the dose
will be based on the child’s body weight.
Use in Elderly
No reduction in dose is necessary unless you
have kidney problems.
Use in Patients with Kidney Problems
If you have problems with your kidneys, the dose
may be reduced. Your doctor will decide what
dose to give you based on a blood test.
Use in Patients with Liver Problems
No reduction in dose is necessary.
Method of Administration
Tranexamic Acid Solution for Injection should
only be injected slowly into a vein. It should not
be injected into a muscle.
If you are given too much Tranexamic Acid
Solution for Injection
If you are given too much Tranexamic Acid Solution
for Injection, you may experience temporary low
blood pressure (you may feel faint or dizzy on
standing). Talk to your doctor or nurse immediately.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience any of the following side
effects after you have been given your
medicine, tell your doctor immediately. If you
are not in hospital, you MUST GO straight away.
These side effects are rare but serious.
• Severe allergic reaction which may include a red
and lumpy skin rash, difficulty breathing, swelling
of face, mouth, lips or eyelids, unexplained high
temperature (fever) and feeling faint.
If the swelling affects your throat and makes
breathing and swallowing difficult, go to
hospital straight away.
• Symptoms of a blood clot which may include
swelling or pain in your legs or chest,
headache, weakness of the face and limbs
on one side of the body.
Other side effects which may occur:
Common (may affect up to 1 in 10 users)
• feeling sick;
• being sick;
• diarrhoea.
Uncommon (may affect up to 1 in 1000 users)
• rash.

Technical Leaflet intended for healthcare professionals only

Paediatrics:
From one year, for the current approved
indications, the dosage is in the region of
20mg/kg/day.
Elderly:
No reduction in dosage is necessary unless there is
evidence of renal failure.
Renal Failure:
Due to the risk of accumulation, the dose should be
reduced according to the following table:

TRANEXAMIC 500MG/5ML SOLUTION FOR INJECTION
GENERAL INFORMATION
Tranexamic Acid 500mg/5ml Solution for Injection is
for single use only. Any portion of the vial not used
at once should be discarded.
THERAPEUTIC INDICATIONS
Prophylaxis/treatment of haemorrhage due to
general or local fibrinolysis in adults and children
over one year due to:
• Menorrhagia and metrorrhagia;
• Gastrointestinal bleeding;
• Haemorrhagic urinary disorders, following
prostate surgery or procedures on the urinary
tract;
• Ear, nose and throat surgery;
• Gynaecological or obstetric surgery;
• Thoracic and abdominal surgery;

Solution

4. Possible side effects

• Haemorrhagic complications in association with
thrombolytic therapy.
POSOLOGY AND METHOD OF ADMINISTRATION
Tranexamic Acid 500mg/5ml Solution for Injection
should be administered by slow intravenous
injection according to the dosage schedule below.
THERAPEUTIC DOSE
Adult:
Local Fibrinolysis: 5-10ml (500-1000mg) by slow
intravenous injection (1ml/min), three times a day.
General Fibrinolysis:
10ml (1000mg) by slow intravenous injection
(1ml/min), every 6 to 8 hours, equivalent to
15mg/kg body weight.

Serum Creatinine Dose iv
120-249mcmol/I 10mg/kg BW
250-500mcmol/I 10mg/kg BW
>500mcmol/I
5mg/kg BW
Method of administration:
Slow intravenous injection only.

12mm

310mm

1. What Tranexamic Acid Solution for
Injection is and what it is used for

• have kidney problems;
• have a history of convulsions (fits).
Due to the risk of fits or swelling in the brain,
injection into the spinal cord, directly into the
heart or into the brain is not recommended.
If you think any of these apply to you, or if you
are in any doubt at all, tell your doctor before
you are given Tranexamic Acid Solution for
Injection.
Warnings and precautions
Tell your doctor if any of the following apply to
you, to help him or her decide if Tranexamic
Acid Solution for Injection is suitable for you:
• if you have had blood in your urine, which
could indicate that there is a clot in your
upper urinary tract;
• if you are at risk of having blood clots;
• if you suffer from excessive clotting or
bleeding throughout your body (disseminated
intravascular coagulation). Your doctor may
carry out a blood test to see if the process that
inhibits blood clotting (called fibrinolysis) is
activated;
• if you have had convulsions (fits). Your
doctor will use the minimum dose possible to
avoid further convulsions after the treatment;
• if you are on long term treatment with
Tranexamic Acid Solution for Injection pay
attention to any possible disturbances in your
colour vision. If necessary, your doctor may
discontinue the treatment. With continuous,
long term use of Tranexamic Acid Solution for
Injection regular eye tests are recommended.
If changes are seen in your eyes, your doctor
may consult an eye specialist in order to
decide whether to continue your treatment.
Other medicines and Tranexamic Acid Solution
for Injection
Please tell your doctor or nurse if you are taking,
or have recently taken, or might take any other
medicines, including medicines obtained
without a prescription.
You should specifically tell your doctor if you
take:
• Other medicines that help blood to clot,
called antifibrinolytic medicines;
• Medicines that prevent blood clotting, called
thrombolytic medicines;
• Oral contraceptives.
Pregnancy, breast-feeding and fertility
• Ask your doctor for advice if you are
pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby.
• Tranexamic acid is excreted in breast milk.
Therefore, the use of Tranexamic Acid
Solution for Injection during breast-feeding is
not recommended.
Driving and using machines
No studies have been performed on the ability
to drive and use machines.

310 mm

Read all of this leaflet carefully before you, or
your child, are given this medicine because
it contains important information for you.

Acid

Dose Frequency
every 12 hours
every 24 hours
every 24 hours

Unknown (the frequency cannot be estimated
from the available data)
• low blood pressure (you may feel generally
unwell, faint or dizzy on standing) which is
usually caused by an injection being given
too quickly;
• fits;
• visual disturbances, including colour disturbance.
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or nurse.
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.co.uk/yellowcard. By
reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Tranexamic Acid Solution
for Injection
Do not store above 25°C. Store in the original
packaging. Do not refrigerate or freeze.
Tranexamic Acid Solution for Injection will be
stored by your doctor, nurse or pharmacist, out
of the sight and reach of children.
Tranexamic Acid Solution for Injection should
not be used after the expiry date stated on the
carton and vial label. The expiry date refers to
the last day of that month.
This product is for single use only. Once your
doctor or nurse has opened the vial, it should
be
used
immediately.
Any
remaining
Tranexamic Acid Solution for Injection must be
thrown away by the doctor or nurse.

6. Contents of the pack and other
information

What Tranexamic Acid Solution for Injection contains
- The active substance is tranexamic acid.
Each 5ml vial contains 500mg tranexamic
acid (100mg per ml).
- The other ingredient is water for injections.
What Tranexamic Acid Solution for Injection
looks like and contents of the pack
This medicine is a clear, colourless solution in a
clear, glass vial. Each vial contains 5ml of
medicine. This product is available in cartons
containing 10 x 5ml vials.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House,
1st Floor, 85 King William Street, London EC4N 7BL, UK.
Tel: 00 44 1283 495 280
Fax: 00 44 1283 495 290
Email: medinfo@focuspharma.co.uk
Manufacturer
Medochemie
Ltd,
Ampoule
Injectable Facility, 48 Lapetou Street, Avios
Athanasios Industrial Estate, 4101, Limassol, Cyprus.
For any information about this medicinal
product, please contact the Marketing
Authorisation Holder, details provided above.
Other sources of information

For information in large print, audio CD or
Braille please telephone
00 44 (0)1283 495 280 or email
medinfo@focuspharma.co.uk.
This leaflet was last revised in 06/2015.

Each ampoule may contain more than the stated
5ml of liquid. This is to ensure that the full 5ml
amount is available. Only 5ml should be withdrawn
from the ampoule for administration to the patient.
Any portion of the ampoule not used at once
should be discarded.
STORAGE AND DISPOSAL OF TRANEXAMIC ACID
SOLUTION FOR INJECTION
Do not store above 25°C. Store in the original
packaging. Do not refrigerate or freeze.
The product should be used immediately after
opening. Any unused product or waste material
should be disposed of in accordance with local
requirements.
Shelf life:
Unopened: 30 months

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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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