PATIENT INFORMATION LEAFLET

This leaflet contains important information about your medicine; read it carefully.

Keep this leaflet; you may want to read it again.

If you have any questions or are not sure about anything, ask your doctor or pharmacist

Desferrioxamine Mesilate 500 mg Powder for Injection

Desferrioxamine Mesilate 2 g Powder for Injection

• The active substance is desferrioxamine mesilate
• There are no other ingredients

1. What Desferrioxamine Mesilate Powder for Injection is and what it is used for

Desferrioxamine mesilate is a chelating (binding) agent for iron and aluminium.

The medicine is presented as a powder which is made into a solution, in glass containers called vials

Vials may contain 500 mg or 2 g of desferrioxamine mesilate.

Packs contain 10 vials of the 500 mg product or 1 vial of the 2 g product.

Desferrioxamine mesilate is used to remove excess iron or aluminium from the body in patients with conditions such as iron poisoning, thalassaemia (a hereditary type of anaemia) haemochromatosis (a disorder of iron metabolism) and aluminium overload due to kidney failure. It may also be used to diagnose certain conditions associated with iron or aluminium overload

2. Before Desferrioxamine Mesilate Powder for Injection is used

3. How Desferrioxamine Mesilate Powder for Injection is used

The dose of medicine given to you will depend on your medical condition, your age and how well your kidneys are working:

Acute iron poisoning: Treatment with desferrioxamine mesilate both by mouth and by injection or infusion (very slow injection) may be required.Treatment may be repeated until iron levels are brought back down to normal levels.

Conditions arising from gradual build up of iron, e.g. thalassaemia: Dosage is determined by assessment of the levels of excess iron in the body. Treatment is usually given by infusion. Treatment may need to be repeated on a daily basis in some cases.

Aluminium overload due to kidney failure: Such patients will already receive dialysis treatment. Desferrioxamine mesilate is given once a week usually by infusion linked to the time of their dialysis.

Diagnosis of conditions associated with iron overload: The amount of iron in the urine following an injection of desferrioxamine mesilate can be used to diagnose certain iron overload conditions.

Diagnosis of aluminium overload: The difference in the amount of aluminium in the bloodstream before and after a slow injection of desferrioxamine mesilate into a vein may help diagnose aluminium overload in certain patients with kidney failure.

This medicine will be diluted with Water for Injections and may be further diluted with glucose solution, sodium chloride solution or a mixture of glucose and sodium chloride solution before it is given to you. It will be given either as an injection under the skin; in to a vein; in to a muscle or in to the cavity of the abdomen OR may be given as an oral solution.

If it is given under the skin or into a vein, it is usually given as a slow injection via a drip (infusion).

As this medicine will be given to you whilst you are in hospital is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns.

4. Possible Side Effects

Like all medicines, desferrioxamine mesilate can have side effects.

If any of the following happen, tell your doctor immediately:

• severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.
• impaired vision/eye disorders
• hearing loss and tinnitus
• fever with a sore throat and abdominal pain or severe diarrhoea
• symptoms of severe infection such as sore throat, abdominal pain or skin infections
• severe breathing difficulties
• faints (possibly due to low blood pressure)/blackouts/fits

These are very serious side effects. You may need urgent medical attention. All of these very serious side effects are rare.

If you experience any of the following tell your doctor as soon as possible:

• skin problems: rash, itching, pain, swelling, burning and hardening of the tissues at the site of the injection
• fever or chills
• malaise
• nausea, vomiting, diarrhoea, abdominal cramps
• leg cramps
• bone pain
• pins and needles
• if you are a child or suffer from ß-thalassaemia, growth retardation (slowing down of your height and weight gain)
• desferrioxamine mesilate may lead to changes in your blood cells and liver and kidney function. Your doctor may take blood tests to monitor for these.

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

5. Storing Desferrioxamine Mesilate Powder for Injection

Keep out of the reach of children

The vials should not be stored above 25°C

Do not refrigerate the prepared solution

This medicine should not be used after the expiry date printed on the vial label