Fibtin 500 mg/5 ml Solution

FIBTIN INJECTION contains the active substance tranexamic acid and belongs to a group of medicines called anti-fibrinolytic medicines. FIBTIN INJECTION 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:

• to treat a defect in your body’s mechanism for blood clotting, before undergoing minor surgery or dental extraction;
• to treat bleeding inside your eye (traumatic hyphaema);
• to treat a hereditary disease called angioedema (HANO). A doctor would have told you if you have this;
• to treat heavy periods (menorrhagia).

FIBTIN INJECTION should not be administered to you:

• If you have a known hypersensitivity (allergy) to tranexamic acid or any of the other ingredients of FIBTIN INJECTION (see section 6).
• If you have blood in your urine as a result of urinary tract bleeding.
• If you are prone to developing blood clots or have a disorder affecting your colour vision.
• If you have inflammation of a vein as a result of a blood clot (called thrombophlebitis).
• If you have liver problems.
• If you had a stroke causing bleeding in the space between your brain and the tissues that cover it (subarachnoid space).
• If you have a blood clot in your blood vessels (called a 'thrombosis').
• If you are at risk of excessive bleeding as a result of a bleeding disorder called consumption coagulopathy.
• 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.

Warnings and precautions

Take special care with FIBTIN INJECTION:

• If you have had convulsions, FIBTIN INJECTION should not be administered. Your doctor must use the minimal dose possible to avoid convulsions following treatment with FIBTIN INJECTION.
• If you are receiving FIBTIN INJECTION for a long time you will need to go for an eye examination. If you experience disturbances with your vision, advise your doctor immediately and FIBTIN INJECTION treatment will be discontinued.
• If you have blood in your urine, it may lead to urinary tract obstruction.
• If you are taking oral contraceptives.
• If you have excessive clotting or bleeding throughout your body (disseminated intravascular coagulation) (DIC). FIBTIN INJECTION 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 or your family have a history of blood clots in your blood vessels (called a 'thrombosis').
• If you have kidney disease.
• If you are being treated with Factor IX Complex Concentrates or Anti-inhibitor Coagulant Concentrates (used to prevent bleeding).
• Patients with very heavy irregular menstrual bleeding should not use FIBTIN INJECTION until the cause of the irregularity has been established.

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself FIBTIN INJECTION. It will be given to you by a person who is qualified to do so. FIBTIN INJECTION 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 receive it.

If you have the impression that the effect of FIBTIN INJECTION is too strong or too weak, tell your doctor or pharmacist.

If you receive more FIBTIN INJECTION than you should Since a health care provider will administer FIBTIN INJECTION, he / she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use FIBTIN INJECTION Since a health care provider will administer FIBTIN INJECTION to you, it is unlikely that the dose will be missed. You should not receive a double dose to make up for a forgotten dose.

FIBTIN INJECTION can have side effects. Not all side effects reported for FIBTIN INJECTION are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving FIBTIN INJECTION, please consult your health care provider for advice. If any of the following happens, you should stop receiving FIBTIN INJECTION and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to FIBTIN INJECTION. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Side effects occurring with unknown frequency:

• convulsions (fits);
• formation of blood clots (unusual pain or swelling in your arms or legs).

These are serious side effects. You may need urgent medical attention. Tell your doctor as soon as possible if you notice any of the following:

Side effects occurring frequently:

• nausea (feeling sick), vomiting (being sick), diarrhoea.

Side effects occurring with unknown frequency:

• dizziness;
• problems with your eyesight, especially your colour vision;
• general feeling of being unwell, low blood pressure (with or without loss of consciousness), especially if the injection is given too quickly.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to the South African Health Products Regulatory Authority (SAHPRA) via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088. By reporting side effects, you can help provide more information on the safety of FIBTIN INJECTION.

• Store at or below 25 °C.
• Do not freeze.
• Protect from light.
• Keep the ampoules in the outer carton until required for use.
• FIBTIN INJECTION is for single use only. Unused solution must be discarded.
• After opening: From a microbiological point of view, FIBTIN INJECTION should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
• Do not use after the expiry date printed on the carton.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).