Siroxtrin Dispersible Tablets

SIROXTRIN contains an active substance called deferasirox an iron chelator used to remove the excess iron from the body tissues. SIROXTRIN is used for:

• Transfusional iron overload (excess amount of iron in patients receiving regular blood transfusions) SIROXTRIN is used to treat iron overload caused by blood transfusions.
• Non-transfusion-dependent thalassaemia syndromes (excess amount of iron in patients with thalassaemia not receiving regular blood transfusions).

Do not take SIROXTRIN :

• If you are hypersensitive (allergic) to deferasirox or any of the other ingredients of SIROXTRIN (listed in section 6).
• If you have any kidney problems.
• If you are using a medicine called repaglinide that is used to control high blood sugar.
• If you have high risk myelodysplastic syndrome (MDS).
• If you have other blood disorders.
• If you have a severe liver disease.
• If you are pregnant or breastfeeding.

Warnings and precautions

Take special care with SIROXTRIN :

• If any of the following applies to you, tell your doctor, pharmacist or healthcare provider before taking SIROXTRIN:
• Extra caution should be used in elderly patients as they may experience side effects more frequently.
• If you have a kidney or a liver problem.
• If you vomit blood and/or have black stools.
• If you are taking anti-inflammatory medicines (NSAIDs) as it may increase the risk of gastrointestinal complications.
• If you develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction, see section 4).
• If you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, enlarged lymph nodes (signs of severe skin reaction, see section 4).
• If you have blurred vision or your hearing is decreasing.
• If you have a low level of platelets or white blood cells in your blood test.
• Blood tests to monitor the amount of ferritin should be done regularly.
• If you have a heart problem due to iron overload.

Children and adolescents

SIROXTRIN can be used to treat adolescents and children aged 2 years and over for chronic iron overload due to blood transfusions and 10 years and over for chronic iron overload with non-transfusion-dependent thalassemia syndromes. The dose of SIROXTRIN is related to body weight for all patients. Your doctor will tell you how many tablets to take.

Do not share medicines prescribed for you with any other person. Always take SIROXTRIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

How much SIROXTRIN to take

• SIROXTRIN can be used to treat adults, adolescents and children aged 2 years and over. The dose of SIROXTRIN is related to body weight for all patients. Your doctor will tell you how many tablets to take.
• The usual daily dose of SIROXTRIN at the start of the treatment is 20 mg per kilogram body weight for patients receiving regular blood transfusions.
• 10 mg per kilogram body weight for patients not receiving regular blood transfusions.
• A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs. Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose.
• The maximum recommended daily dose is:
• 40 mg per kilogram body weight for patients receiving regular blood transfusions.
• 20 mg per kilogram body weight for patients not receiving regular blood transfusions.

Take SIROXTRIN:

• Once a day, every day, at about the same time each day.
• On an empty stomach at least 30 minutes before eating any food.
• Disperse the tablets completely by stirring in a glass of water, apple or orange juice until a suspension forms. Drink the entire contents of the glass, then add a little water or juice to what is left in the empty glass and drink that too.

Your doctor will tell you how long your treatment with SIROXTRIN will last. If you have the impression that the effect of SIROXTRIN is too strong or too weak, tell your doctor or pharmacist.

SIROXTRIN can have side effects. Not all side effects reported for SIROXTRIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SIROXTRIN, please consult your health care provider for advice.

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

• swelling of the hands, feet, ankles, face, lips and 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 SIROXTRIN. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

• Frequent headache,
• diarrhoea (runny tummy), constipation,
• feeling sick (nausea), being sick (vomiting),
• pain in the stomach, bloating, indigestion,
• rash,
• itching,
• a marked decrease in your urine output (sign of kidney problem),
• disturbance in urine test (protein in the urine).

Less frequent:

• anxiety,
• sleep disorders,
• dizziness,
• partial loss of vision,
• blurred or cloudy eyesight,
• reduced hearing,
• sore throat,
• inflammation of the lining of the stomach (gastritis),
• vomit blood and/or have black stools,
• abdominal pain, particularly after eating or taking SIROXTRIN,
• heartburn,
• disturbance in kidney function test,

You will have some blood tests while taking SIROXTRIN . Your doctor will look for any changes in the kidney function (level of creatinine) or liver function (level of transaminases). Your doctor may also want to test your eyesight and hearing while you are taking SIROXTRIN. 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 SIROXTRIN.

Store all medicines out of reach of children.

• Store at or below 25 °C.
• Do not use after the expiry date stated on the blister / bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).