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CYKLOKAPRON 500 MG FILM-COATED TABLETS

Active substance(s): TRANEXAMIC ACID / TRANEXAMIC ACID / TRANEXAMIC ACID

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Patient Information Leaflet

Cyklokapron® 500 mg film-coated tablets
Tranexamic acid
Read all of this leaflet carefully before you start taking 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 or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
• In this leaflet, Cyklokapron 500 mg film-coated tablets will be called Cyklokapron.
What is in this leaflet:
1. What Cyklokapron is and what it is used for
2. What you need to know before you take Cyklokapron
3. How to take Cyklokapron
4. Possible side effects
5. How to store Cyklokapron
6. Contents of the pack and other information.

Do not take Cyklokapron if:
• You are allergic to tranexamic acid or any of the other ingredients of 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 Cyklokapron 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 Cyklokapron
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, in particular the following:
• Fibrinolytic drugs (used to help dissolve blood clots), such as streptokinase. This is because
Cyklokapron will stop these drugs working
• Oral contraceptives. These may increase the risk of blood clots forming
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.

3. How to take Cyklokapron
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 the elderly:
• The usual dose is 2 or 3 tablets taken two to three times daily

Manufacturer

2. What you need to know before you take Cyklokapron

MEDA
SPECIFICATION BOX

Cyklokapron contains the active substance tranexamic acid and 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. Cyklokapron stops
these clots dissolving and so reduces unwanted bleeding.
Cyklokapron is 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)
• Nose bleeds (epistaxis)
• Cervical surgery (conisation of the cervix)
• Bleeding inside the eye (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.

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1. What Cyklokapron is and what it is used for

• 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 and adolescents:
• 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.
Use in 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 Cyklokapron than you should
If you accidentally take too much of your medicine, immediately tell your doctor or go to the
nearest hospital casualty department.
Taking too much Cyklokapron may make you feel sick, be sick or be dizzy or light-headed
upon standing.
If you forget to take Cyklokapron
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 about the use of this medicine, ask your doctor or pharmacist.

5. How to store Cyklokapron
Keep this medicine out of the sight and reach of children.
Do not use Cyklokapron after the expiry date on the carton. The expiry date refers to the last
day of that month.
Do not store above 25 °C.
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 protect the
environment.

6. Contents of the pack and other information
What Cyklokapron contains:
• The active substance is tranexamic acid. Each tablet contains 500 mg tranexamic acid.
• The other ingredients are microcrystalline cellulose (E460), hydroxypropyl cellulose (E463),
talc (E553b), magnesium stearate (E572), colloidal anhydrous silica, povidone (E1201),
methacrylate polymers, titanium dioxide (E171), polyethylene glycol 8000, vanillin.
What Cyklokapron looks like and contents of the pack
Cyklokapron tablets are white, oblong film-coated tablets. They are marked with CY with an
arc above and below the lettering.
The tablets come in plastic bottles containing 50 tablets or in blister packs containing 60 tablets.
Not all pack sizes are marketed.
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd., Skyway House, Parsonage Road, Takeley, Bishop’s Stortford,
CM22 6PU, UK.
Manufacturers
MEDA Manufacturing GMBH, Neurather Ring 1, 51063 Cologne, Germany.
This leaflet was last revised in June 2016

If this leaflet is difficult to see or read, or you would
like it in a different format, please contact Meda
Pharmaceuticals Ltd, Skyway House, Parsonage
Road, Takeley, Bishop’s Stortford, CM22 6PU, UK. T5008037

Manufacturer

MEDA
SPECIFICATION BOX

Like all medicines Cyklokapron can cause side effects, although not everybody gets them.
Eye disorders
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
Immune system disorders
Very rare (affects less than 1 user in 10,000)
– this includes allergic reactions which cause difficulty in breathing or dizziness.
Vascular disorders
Very rare (affects less than 1 user in 10,000)
– A blood clot in your blood vessels (called a `thrombosis’).
Gastrointestinal disorders
Very rare (affects less than 1 user in 10,000)
– Feeling sick
– Being sick
– Diarrhoea
These are usually mild and pass very quickly, but if they continue, tell your doctor or
pharmacist.
Skin and subcutaneous tissue disorders
Rare (affects 1 to 10 users in 1,000)
– Itchy, red or swollen skin
Nervous system disorders
Frequency not known (cannot be estimated from the available data)
– Convulsions, particularly in cases of misuse
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. By reporting side effects you can help
provide more information on the safety of this medicine.

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4. Possible side effects

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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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