Cyklokapron 100 Mg / Ml 10 Ampoules

1. What this product 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 gynecological surgery - bleeding after you have been treated with another medicine to break down blood clots. 2. What you need to know before you use this product Do not take Cyklokapron: · If you are allergic to tranexamic acid or any of the other ingredients of this medicine (listed in section 6). · If you have currently a disease leading to blood clots. · If you have a condition called ‘consumption coagulopathy’ where blood in the whole body starts to clot. · If you have kidney problems. · If you 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 be 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 test 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,, 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 in your case. Other medicines and Cyklokapron Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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 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. 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 use this product. Cyklokapron will be given to you by slow injection or infusion into a vein. Your doctor will decide the correct dose for you and how long you should take it. Use in children If Cyklokapron 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 administrated 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.