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CYKLOKAPRON INJECTION

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Package leaflet: Information for the patient

Cyklokapron® Injection 500 mg
tranexamic acid

8R2843
88

Read all of this leaflet carefully before you are given 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 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 Cyklokapron is and what it is used for
2. What you need to know before you are given Cyklokapron
3. How to take Cyklokapron
4. Possible side effects
5. How to store Cyklokapron
6. Contents of the pack and other information
1. What Cyklokapron is and what it is used for
Cyklokapron contains tranexamic acid which belongs to a group of medicines called antihaemorragics;
antifibrinolitics, aminoacids.
Cyklokapron 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 indications include:
- Heavy periods in women
- Gastrointestinal bleeding
- Haemorrhagic urinary disorders, further to prostate surgery or surgical procedures affecting the
urinary tract
- Ear, nose or throat surgery
• 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 Cyklokapron
Do not take Cyklokapron if you:
• are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6)
• have currently a disease leading to blood clots
• have a condition called ‘consumption coagulopathy’ where blood in the whole body starts to clot
• have kidney problems
• have a history of convulsions
Due to the risk of cerebral oedema and convulsions, intrathecal and intraventricular injection and
intracerebral application are not recommended.
If you think any of these apply to you, or if you are in any doubt at all, tell your doctor before taking
Cyklokapron.
Warnings and precautions
Tell your doctor if any of these apply to you to help him or her decide if Cyklokapron is suitable for you:
• If you have had blood in your urine, it may lead to urinary tract obstruction.
• If you have a risk of having blood clots.
• If you have excessive clotting or bleeding throughout your body (disseminated intravascular
coagulation), Cyklokapron may not be right for you, except if you have acute severe bleeding and
blood tests have shown the process that inhibits blood clotting called fibrinolysis is activated.
• If you have had convulsions, Cyklokapron should not be administered. Your doctor must use the
minimal dose possible to avoid convulsions following treatment with Cyklokapron.
• If you are on a long-term treatment with Cyklokapron, attention should be paid to possible
disturbances of colour vision and if necessary the treatment should be discontinued. With continuous
long-term use of Cyklokapron solution for injection, regular ophthalmologic examinations (eye
examinations including visual acuity, colour vision, fundus, visual field etc.) are indicated. With
pathological ophthalmic changes, particularly with diseases of the retina, your doctor must take a
decision after consulting a specialist on the necessity for the long-term use of Cyklokapron solution
for injection in your case.
Other medicines and Cyklokapron
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription, vitamins, minerals, herbal medicines or dietary
supplements.
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 and breast-feeding
Ask your doctor for advice if you are pregnant or breast-feeding before taking Cyklokapron. Tranexamic
acid is excreted in human milk. Therefore, the use of Cyklokapron during breast-feeding is not
recommended.
Driving and using machines
No studies have been performed on the ability to drive and use machines.

3. How to take Cyklokapron
Use in adults
Cyklokapron solution for injection will be given to you by slow injection into a vein.
Your doctor will decide the correct dose for you and how long you should take it.
Use in children
If Cyklokapron solution for injection is given to a child from one year, the dose will be based on the child’s
weight.
Your doctor will decide the correct dose for the child and how long he/she should take it.
Use in elderly
No reduction in dosage is necessary unless there is evidence of renal failure.
Use in patients with kidney problem
If you have a kidney problem, your dose of tranexamic acid will be reduced according to a test performed
on your blood (serum creatinine level).
Use in patients with hepatic impairment
No reduction in dosage is necessary.
Method of administration
Cyklokapron should only be administered slowly into a vein.
Cyklokapron must not be injected into a muscle.
If you are given more Cyklokapron than the recommended dose
If you are given more Cyklokapron than the recommended dose you may experience a transitory blood
pressure lowering. Talk to a doctor or pharmacist immediately.
4. Possible side effects
Like all medicines this medicine can cause side effects although not everybody gets them.
Side effects reported with Cyklokapron are:
The following side effects have been observed with Cyklokapron
Common (may affect up to 1 in 10 users)
• effects on the stomach and intestines: nausea, vomiting, diarrhoea
Uncommon (may affect 1 to 10 in 1000 users)
• effects on the skin problems: rash
Not known (frequency cannot be estimated from the available data)
• malaise with hypotension (low blood pressure), especially if the injection is given too quickly
• blood clots
• effects on the nervous system: convulsions
• effects on the eyes: vision disturbances including impaired colour vision
• effects on the immune system: allergic reactions
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 pharmacist.
5. How to store Cyklokapron
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 carton and ampoule label after Exp.
The expiry date refers to the last day of that month. Your doctor or nurse will check this before the
injection is given.
The unopened ampoules have no special storage precautions.
6. Contents of the pack and other information
What Cyklokapron contains
The active substance is tranexamic acid.
Each 5 ml of the solution contains 500 mg of tranexamic acid.
The other ingredient is water for injections.
What Cyklokapron looks like and contents of the pack
Cyklokapron is a solution for injection in glass ampoules containing 500 mg in 5 ml solution.
Cyklokapron Injection is available in packs of 10 x 5 ml glass ampoules.
Marketing Authorisation Holder and Manufacturer:
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
UK
Manufacturer:
Pfizer Manufacturing Belgium NV
Rijksweg 12
B-2870 PUURS
BELGIUM
Company contact address:
For further information on your medicine contact Medical Information at the following address:
Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS
Telephone 01304 616161
This leaflet was last revised in: 11/2012
Ref: CK 6_0

8R2843

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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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