Klotigo Solution

The active ingredient, tranexamic acid, belongs to a group of medicines called coagulants (haemostatics). KLOTIGO may be used for the short-term prevention and treatment of bleeding disorders due to a process that inhibits blood clotting called fibrinolysis. You may have been prescribed it for one of the following:

• prostate or bladder surgery
• nose bleeds (epistaxis)
• abnormalities of the cervix
• bleeding inside the eye (hyphaema)
• tooth removal (dental extraction) in haemophiliacs
• hereditary angioedema (a genetic disease that causes swelling of the skin and tissue just beneath the skin)
• menorrhagia (menstrual periods with abnormally heavy or prolonged bleeding).

KLOTIGO should not be administered:

• if you are hypersensitive (allergic) to tranexamic or any of the other ingredients of KLOTIGO (see section 6)
• if you have had blood in your urine (urinary tract bleeding), it may lead to urinary tract obstruction
• if you are prone to develop blood clots, have blood clots (a condition called thrombophlepitis) or your colour vision is disturbed
• if you have impaired liver function
• if you have bleeding in the brain membranes (the main symptom is a sudden, severe headache)
• if you have a condition called ‘consumption coagulopathy’ (also called disseminated intravascular coagulation) where blood in the whole body starts to clot, blocking small blood vessels. Symptoms may include chest pain, shortness of breath, leg pain, problems speaking, or problems moving parts of the body
• if you have a history of convulsions (fits)
• if you currently have a disease leading to blood clots.

Warnings and precautions

Convulsions (fits) have been reported with KLOTIGO, particularly at high doses (see KLOTIGO should not be administered to you and section 4, Possible Side Effects). Tell your doctor or healthcare professional before being given the injection:

• if you have vision problems, as your colour vision may be affected with long-term treatment with KLOTIGO. If necessary, your doctor will consider stopping the treatment. If you receive KLOTIGO for an extended period, you should have regular eye examinations
• if you had a stroke, or someone in your family had a stroke as you will have an increased risk of having blood clots or have a condition (high blood pressure, high blood cholesterol) that may cause the formation of blood clots
• if you take hormonal contraceptives or hormone replacement therapy, as you will have an increased risk of having blood clots;
• if you have impaired kidney or liver function
• if you have had blood in your urine, it may lead to urinary tract obstruction, that can cause kidney damage, kidney stones and infection
• if you have excessive clotting or bleeding throughout your body (disseminated intravascular coagulation)
• if you have a risk of having blood clots and/or if you are receiving Factor IX Complex Concentrates or Anti-inhibitor Coagulant Concentrates as KLOTIGO may increase your risk of blood clotting

Patients with very heavy irregular menstrual bleeding should not use KLOTIGO until the cause of the irregularity has been established.

Other medicines and KLOTIGO

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.) This is especially important with the following medicines:

• other medicines that help blood to clot, called antifibrinolytic medicines or called Factor IX Concentrates or Auto-inhibitor Coagulant Concentrates
• medicines that prevent blood clotting, called anticoagulant thrombolytic medicines
• oestrogens (as in oral contraceptives or hormone replacement therapy).

Do not share medicines prescribed for you with any other person. You will not be expected to give yourself KLOTIGO. It will be given to you by a person who is qualified to do so. KLOTIGO is only intended for slow administration into a vein; it may not be injected into a muscle or any other route.

Adults: The usual dose range in adults is 1000 - 1500 mg (10 - 15 mL) every 8 hours. This will usually be given by a slow injection into your vein. Your doctor will decide what dose you need and for how long you should be treated with KLOTIGO.

Children: Adequate information is not available.

Patients with kidney problems: If you have problems with your kidneys, your doctor will decide what dose to give you, based on a blood test.

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

If you are administered more KLOTIGO than you should: Since a healthcare provider will administer KLOTIGO, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If they forget to administer a dose of KLOTIGO to you: Since a healthcare professional will administer KLOTIGO, it is unlikely that the dose will be missed.

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

If any of the following happens, stop using KLOTIGO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the 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 allergic reaction to KLOTIGO. 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:

• a blood clot in an artery (arterial thrombosis). Tell your doctor if you have chest pain, shortness of breath and dizziness
• a blood clot in a vein (venous thrombosis). Tell your doctor if you have swelling redness, and pain in your foot, ankle, or leg, usually on one side
• affected eyesight, including impaired colour vision

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:

• Nausea (feeling sick)
• Vomiting (being sick)
• Diarrhoea (loose bowels)

Less frequent side effects:

• skin rashes, itching
• feeling unwell and having too low blood pressure (you may feel dizzy and faint if you get up; your doctor will test your blood pressure to confirm)

The following side effects have been reported but the frequency for them to occur is not known:

• dizziness (a sensation of whirling and a tendency to fall or stagger)
• convulsions (fits)
• blood clots

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 SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of KLOTIGO. You can also send an email directly to the company, [email protected], to ensure safety of the product.

Store all medicines out of reach of children. Store the ampoules at or below 25 °C. Keep ampoules in carton to protect from light. After first opening: The solution for injection is for single use only. Unused solution for injection should be discarded. Chemical and physical in-use stability of the infusion solutions have been demonstrated for 24 hours at 2 - 8 °C. Mixtures not used within 24 hours of preparation should be discarded. Do not freeze. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).