Package leaflet: Information for the patient

Cyklokapron® Injection 500 mg

tranexamic acid

ninnii

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