Ferriprox 500 mg film-coated tablets

Ferriprox contains the active substance deferiprone. Ferriprox is a medicine that removes iron from the body.

Ferriprox is used to treat iron overload caused by frequent blood transfusions in patients with thalassaemia major when deferoxamine therapy is contraindicated or inadequate.

Do not take Ferriprox if you are allergic hypersensitive to deferiprone or any of the other ingredients of Ferriprox. if you have a history of repeated episodes of neutropenia low white blood cell neutrophil count. if you have a history of agranulocytosis very low white blood cell neutrophil count. if you are currently taking medicines known to cause neutropenia or agranulocytosis see Taking other medicines. if you are pregnant or breastfeeding.

Take special care with Ferriprox

- the most serious side effect that may occur while taking Ferriprox is a very low white blood cell (neutrophil) count. This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken Ferriprox in clinical studies. Because white blood cells help to fight infection, a low neutrophil count may place you at risk of developing a serious and potentially life-threatening infection. To monitor for neutropenia, your doctor will ask you to have a blood test (to check your white blood cell count) performed regularly, as frequently as every week, while you are being treated with Ferriprox. It is very important for you to keep all of these appointments. Please refer to the patient/carer reminder card attached to this leaflet. Report immediately to your doctor any symptoms of infection such as fever, sore throat or flu-like symptoms.
- if you are HIV positive or if your kidney and liver function is impaired, your doctor may recommend additional tests.

Your doctor will also ask you to come in for tests to monitor body iron load. In addition he or she also might ask you to undergo liver biopsies.

Taking other medicines

Do not take medicines known to cause neutropenia or agranulocytosis (see ?Do not take Ferriprox?). Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not take aluminium-based antacids while taking Ferriprox.

Please consult with your doctor or pharmacist before taking vitamin C with Ferriprox.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or if you are trying to become pregnant. This medicine could seriously harm your baby. You must use effective contraception while you are taking Ferriprox. 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.

Do not use Ferriprox if you are breast-feeding. Please refer to the patient/carer reminder card attached to this leaflet.

Driving and using machines

Not relevant.

Always take Ferriprox exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The amount of Ferriprox that you take will depend on your weight. The usual dose is 25 mg/kg, 3 times per day, for a total daily dose of 75 mg/kg/day. The total daily dose should not exceed 100 mg/kg/day. Take your first dose in the morning. Take your second dose midday. Take your third dose in the evening. Ferriprox can be taken with or without food; however, you may find it easier to remember to take Ferriprox if you take it with your meals.

If you take more Ferriprox than you should

There are no reports of acute overdose with Ferriprox. If you have accidentally taken more than the prescribed dose, you should contact your doctor.

If you forget to take Ferriprox

Ferriprox will be most effective if you do not miss any doses. If you do miss one dose take it as soon as you remember and take your next dose at its regularly scheduled time. If you miss more than one dose do not take a double dose to make up for forgotten individual doses, just continue with your normal schedule. Do not change your daily dose without first talking to your doctor.

Like all medicines, Ferriprox can have side effects, although not everybody gets them.

The most serious side effect of Ferriprox is a very low white blood cell (neutrophil) count. This condition, known as severe neutropenia or agranulocytosis, has occurred in 1 to 2 out of 100 people who have taken Ferriprox in clinical studies. A low white blood cell count can be associated with a serious and potentially life-threatening infection. Report immediately to your doctor any symptoms of infection such as: fever, sore throat or flu-like symptoms.

Very common side effects (affects more than 1 user in 10):

• abdominal pain
• nausea
• vomiting
• reddish/brown discolouration of urine

If you experience nausea or vomiting, it may help to take your Ferriprox with some food. Discoloured urine is a very common effect and is not harmful.

Common side effects (affects 1 to 10 users in 100):

• low white blood cell count (agranulocytosis and neutropenia)
• headache
• diarrhoea
• increase in liver enzymes
• fatigue
• increase in appetite

Events of joint pain and swelling ranged from mild pain in one or more joints to severe disability. In most cases, the pain disappeared while patients continued taking Ferriprox.

In post-marketing experience with Ferriprox, neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years. They recovered from these symptoms after Ferriprox discontinuation.

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

Keep out of the reach and sight of children.
Do not use Ferriprox after the expiry date which is stated on the carton and the label after EXP. Do not store above 30ºC.

What Ferriprox contains

The active substance is deferiprone. Each tablet contains 500 mg deferiprone.

The other ingredients are:

Tablet core: Microcrystalline cellulose, Magnesium stearate, Colloidal silicon dioxide.

Coating: Hypromellose, Macrogol, Titanium dioxide.

What Ferriprox looks like and contents of the pack

Ferriprox tablets are white to off-white, capsule-shaped, film-coated tablets imprinted ?APO? bisect ?500? on one side, plain on the other. The tablets are scored and breakable in half. Ferriprox is packaged in bottles of 100 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Apotex Europe B.V.
Darwinweg 20
2333 CR Leiden
Netherlands

Manufacturing Authorisation Holder Apotex Nederland B.V. Bio Science Park Archimedesweg 2 2333 CN Leiden Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien SWEDISH ORPHAN INTERNATIONAL SARL TélTel 33 1 41 92 18 01 LuxembourgLuxemburg SWEDISH ORPHAN INTERNATIONAL SARL TélTel 33 1 41 92 18 01

. 359 2 920 12 05 Magyarország Torrex Chiesi Hungária Kereskedelmi Kft. Tel. 36-1-429 1060

eská republika Apotex CR Tel 00420 234 705 700 Malta Swedish Orphan International s.r.l. Tel 39 0521 19111

Danmark SWEDISH ORPHAN AS Tlf 45 32 96 68 69 Nederland SWEDISH ORPHAN INTERNATIONAL LTD Tel 44 1638 72 23 80

Deutschland SWEDISH ORPHAN INTERNATIONAL GmbH Tel 49 6103 20 26 90 Norge SWEDISH ORPHAN AS Tlf 47 66 82 34 00

Eesti Oy SWEDISH ORPHAN Ab Tel 358 201 558 840 Österreich SWEDISH ORPHAN INTERNATIONAL GmbH Tel 49 6103 20 26 90

DEMO ABEE 30 210 8161802 Polska Apotex Inc. Korporacja Przedstawicielstwo w Polsce Tel. 48 22 812 10 02

España Swedish Orphan International Spain S.L. Tel 34 913 91 35 80 Portugal SWEDISH ORPHAN INTERNATIONAL AB Tel 351 21 383 08 91

France Swedish Orphan International SARL Tél 33 1 41 92 18 01 România Torrex Chiesi Pharma GmbH Tel 40 729 995 020

Ireland SWEDISH ORPHAN INTERNATIONAL LTD Tel 44 1638 72 23 80 Slovenija Torrex Chiesi Slovenija, d.o.o. Tel 386-1-43 00 901

Ísland SWEDISH ORPHAN AS Sími 45 32 96 68 69 Slovenská republika Torrex Chiesi Slovakia, s.r.o. Tel 421-2-59 30 00 60

Italia Chiesi Farmaceutici S.p.A Tel 39 0521 2791 SuomiFinland Oy SWEDISH ORPHAN Ab PuhTel 358 201 558 840

The Star Medicines Importers Co. Ltd. 357 25 371056 Sverige SWEDISH ORPHAN AB Tel 46 8 412 98 00

Latvija Oy SWEDISH ORPHAN Ab Tel 358 201 558 840 United Kingdom SWEDISH ORPHAN INTERNATIONAL LTD Tel 44 1638 722380

Lietuva
Oy SWEDISH ORPHAN Ab
Tel: + 358 201 558 840

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