Tranmenxio IV 500 mg/5 ml Solution

The name of your medicine is TRANMENXIO IV. TRANMENXIO IV contains a medicine called tranexamic acid. This belongs to a group of medicines called coagulants, antihaemorrhagics, antifibrinolytics.

Specific indications include:

• Blood inside the front chamber of eye,
• Hereditary angioedema, a genetic form of relapsing subcutaneous or submucosal edema.

Do not take TRANMENXIO IV if:

• If you are allergic to tranexamic acid or any of the other ingredients of TRANMENXIO IV.
• If you have currently a disease leading to blood clots in your blood vessels (arteries or veins).
• If you have a condition called ‘consumption coagulopathy’ where blood in the whole body starts to clot,
• If you have a history of convulsions (fits),
• If you have a massive upper urinary tract bleeding episode,
• If you have known or pronounced tendency of clotting of the blood in a part of circulatory system,
• If you have known or pronounced disturbances in your colour vision,
• If you suffer from thrombophlebitis (swelling/inflammation of a vein caused by a blood clot),
• If you have impaired liver function,
• If you have bleeding into the subarchnoid space - the area between the archnoid membrane and the pia matter surrounding the brain.

Do not have TRANMENXIO IV if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before you are given TRANMENXIO IV.

Warnings and Precautions

You should receive TRANMENXIO IV through a very slow intravenous injection, and never by intramuscular route.

Tell your doctor or health care provider before being given the injection:

• If you have had convulsions (fits). Your doctor will use the minimum dose possible to avoid further convulsions after the treatment,
• If you are on a long-term treatment with TRANMENXIO IV, attention should be paid to possible disturbances of colour vision and if necessary, the treatment should be stopped.
• With continuous long-term use of TRANMENXIO IV longer than several days regular ophthalmologic examinations (eye examinations including visual acuity, colour vision, fundus, visual field etc.), are indicated.
• If you are diagnosed with a disease of the retina. As the doctor will have to decide on the necessity of the long-term use of TRANMENXIO IV.
• If you have a known family history of risk of having blood clots, or previous history of a blood clot, TRANMENXIO IV treatment should be given only if absolutely necessary under strict medical supervision, and should not be given unless simultaneous with anticoagulants,
• if you have had blood in your urine, which could indicate that there is a clot in your upper urinary tract,
• If you have kidney failure, as your doctor will use it with the utmost caution, should therapy be required
• If you have excessive clotting or bleeding throughout your body (disseminated intravascular coagulation, or DIC) as tranexamic acid may not be right for you,
• If you are a haemophiliac (have a hereditary bleeding condition), you should not be receiving TRANMENXIO IV at the same time as with Factor IX Complex Concentrates (medication made up of blood clotting factors used to treat and prevent bleeding in haemophilia) or Anti-inhibitor Coagulant Concentrates (medication to control bleeding in haemophilia), as the risk of clotting (thrombosis) may be increased.
• If you are currently on oral contraceptives, due to the risk of blood clotting.
• If you are on treatment to help your blood clot
• If you are on treatment that prevents blood clotting
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

You will not be expected to give yourself TRANMENXIO IV. It will be given to you by a person who is qualified to do so.

How tranexamic acid is given

Tranexamic acid injection will be administered to you slowly (over a period of at least five minutes) into a vein.

How much tranexamic acid is given

Your doctor will determine the dosage and administer it. Your doctor will tell you how long treatment with TRANMENXIO IV will last. If you have the impression that the effect of TRANMENXIO IV is too strong or too weak, tell your doctor or pharmacist.

Use in patients with kidney problem

If you have kidney problems, your dose may be reduced. Your doctor will decide what dose to give you based on a blood test.

If you take more TRANMENXIO IV than you should

Since a health care provider will administer TRANMENXIO IV, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to use TRANMENXIO IV

Since a healthcare professional will administer this medicine, it is unlikely that the dose will be missed.

TRANMENXIO IV can have side effects. Not all side effects reported for TRANMENXIO IV are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens after you have received TRANMENXIO IV, 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, hives or itching;
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to TRANMENXIO IV. 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:

• Hypotension (low blood pressure), with or without loss of consciousness
• blood clots
• convulsions (fits)
• Vision disturbances including impaired colour vision
• diarrhoea, nausea and vomiting

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

effects on the stomach and intestines: nausea, vomiting, diarrhoea

Less frequent side effects

effects on the skin problems: rash

malaise (a general feeling of discomfort, illness, or unease whose exact cause is difficult to identify) with hypotension (low blood pressure), with or without loss of consciousness, especially if the injection is given too quickly

blood clots

effects on the nervous system: convulsions (fits), dizziness

effects on the eyes: vision disturbances including impaired colour vision, Retinal/artery occlusion which is the blockage of the retinal artery carrying oxygen to the nerve cells in the retina, resulting in severe loss of vision

effects on the immune system: severe allergic reactions

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 or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of TRANMENXIO IV.

Store at or below 25 °C. Keep this medicine out of the sight and reach of children. Use immediately after opening. Discard any unused portion.