Each tablet contains 500 mg of deferiprone as the active ingredient.

It also contains the following inactive ingredients:

• microcrystalline cellulose
• magnesium stearate
• silicon dioxide
• hypromellose
• macrogol 3350
• titanium dioxide.
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• What is Ferriprox used for?
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• Ferriprox contains the active ingredient deferiprone and is used for the treatment of iron overload in patients with thalassaemia major who are unable to take desferrioxamine or in whom desferrioxamine therapy has proven ineffective.

Ferriprox is a medicine that removes iron from the body.

In a disease such as thalassaemia major, there is accumulation of iron in the body in those patients who are dependent on blood transfusions. If not removed, the iron levels can reach a serious level in the body as a result of the accumulation. By removing the excess iron from the body, Ferriprox can reduce the serious effects of iron overload.

When you must not take it

Do not take Ferriprox if you or your child:

• have a history of hypersensitivity (an allergy) to deferiprone or any of the other ingredients listed at the end of this leaflet. Signs of allergic reactions may include itchy skin, rash, shortness of breath and swelling of the face or tongue.
• have a history of repeated episodes of neutropenia (low white blood cell count).
• have a history of agranulocytosis (very low white blood cell count less than 0.5x10^9/L).

Do not take this medication if you are breast-feeding, if you are pregnant, or if you are trying to become pregnant.

This medication could seriously harm your baby. You must use effective contraception while you are taking deferiprone.

Ask your doctor which method is best for you. If you become pregnant while taking Ferriprox, stop taking the medicine immediately and tell your doctor.

Before you start to take it:

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or intend to become pregnant or breast-feeding.

Tell your doctor if you have any of the following medical conditions:

• hepatitis
• HIV
• liver or kidney disease
• problems with your immune system.

Taking other medicines:

Tell your doctor or pharmacist about all other medications that you are taking, even ones that you can buy without a prescription.

Do not take vitamin C or antacids containing aluminium at the same time as Ferriprox.

Do not take medicines which can cause neutropenia or agranulocytosis at the same time as Ferriprox.

Your doctor can advise you on this and tell you which medicines you can safely take with Ferriprox.

How much to take:

How much of Ferriprox that you take will depend on your weight. The usual dose of Ferriprox is three (3) times per day. Your doctor will advise you on how much to take.

Do not take more than the dose your doctor has recommended.

When to take it:

Take your first dose in the morning. Take your second dose midday. Take your third dose in the evening.

You do not have to take this medicine with food. However, you may find it easier to remember to take your medicine, if you take it with your meals. If you experience nausea or vomiting, it may help to take your Ferriprox with some food.

How long to take it for:

Do not stop taking Ferriprox unless your doctor tells you to.

If Ferriprox has been successfully reducing the levels of iron in your body, stopping Ferriprox will cause the iron levels in your body to rise again and the risk of problems with excess body iron may return.

If you forget to take it:

Ferriprox will be most effective if you do not miss any doses.

If you forget to take a dose of Ferriprox, leave out that dose completely. Take your next dose at the normal time it is due.

Do not take a double dose to make up for missed doses.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

Things you must do

Make sure that all of your doctors and pharmacists know about your use of Ferriprox. Remind them if any new medicines are about to be started.

Be sure to keep all of your doctor’s appointments so your progress can be checked.

Your doctor will ask you to come in for tests to monitor body iron load. As a precaution, your doctor may have your blood, liver and kidney tested regularly during treatment with Ferriprox. Some blood tests may be done as often as once a week to avoid side effects.

In addition, he or she also might ask you to undergo liver biopsies.

Things you must not do

Do not use Ferriprox to treat any complaint other than that directed by your doctor.

It may not be safe to use Ferriprox for another complaint.

Do not give Ferriprox to someone else even if their symptoms are the same.

It may not be safe for another person to use Ferriprox.

Things to be careful of:

Ferriprox should not affect your ability to drive or use machinery. However, be careful driving, operating machinery or doing jobs that require you to be alert until you know how this medicine affects you.