Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DEFERIPRONE
PHARMAFORTE (MALAYSIA) SDN. BHD.
DEFERIPRONE
50 Tablets
APOTEX INC. - ETOBICOKE SITE
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ FERRIPROX ® 1000MG DELAYED-RELEASE TABLETS Deferiprone (1000mg) WHAT IS IN THIS LEAFLET 1. What Ferriprox is used for 2. How Ferriprox works 3. Before you use Ferriprox 4. How to use Ferriprox 5. While you are using it 6. Side effects 7. Storage and Disposal of Ferriprox 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT FERRIPROX IS USED FOR Ferriprox is used to treat iron overload in patients with thalassemia (a type of blood disorder) major when deferoxamine therapy is contraindicated or inadequate. HOW FERRIPROX WORKS Ferriprox contains the active substance deferiprone. Ferriprox removes excess iron from the body that accumulates from frequent blood tranfusions. BEFORE YOU USE FERRIPROX - _When you must not use it _ Do not use this product if you are allergic to deferiprone or any of the other ingredients of Ferriprox. Do not use this product if you have a history of repeated episodes of neutropenia (low white blood cell (neutrophil) count), or if you have a history of agranulocytosis (very low white blood cell count). _Pregnancy and lactation _ _ _ Do not take Ferriprox if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take Ferriprox if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it _ Before you start to use this product, let your doctor know if you have any other known medical condition, or if you have undergo any type of surgery, both major or minor. - _Taking other medicines _ Do not take aluminium-based antacids while taking Ferriprox. It is also advised to consult your doctor or pharmacist before taking Vitamin C with Ferriprox. Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. HOW TO USE FERRIPROX - _How much to use _ The amount of Ferriprox that you take will depend on your weight. The recommend Přečtěte si celý dokument
1 HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FERRIPROX 1000 MG DELAYED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FERRIPROX DELAYED-RELEASE TABLETS. FERRIPROX ® 1000 MG DELAYED-RELEASE TABLETS (DEFERIPRONE), FOR ORAL USE WARNING: AGRANULOCYTOSIS AND NEUTROPENIA _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _ • FERRIPROX CAN CAUSE AGRANULOCYTOSIS THAT CAN LEAD TO SERIOUS INFECTIONS AND DEATH. NEUTROPENIA MAY PRECEDE THE DEVELOPMENT OF AGRANULOCYTOSIS. (5.1) • MEASURE THE ABSOLUTE NEUTROPHIL COUNT (ANC) BEFORE STARTING FERRIPROX AND MONITOR REGULARLY WHILE ON THERAPY. (5.1) • INTERRUPT FERRIPROX IF NEUTROPENIA DEVELOPS. (5.1) • INTERRUPT FERRIPROX IF INFECTION DEVELOPS AND MONITOR THE ANC MORE FREQUENTLY. (5.1) • ADVISE PATIENTS TAKING FERRIPROX TO REPORT IMMEDIATELY ANY SYMPTOMS INDICATIVE OF INFECTION. (5.1) ----------------------------- INDICATIONS AND USAGE -------------------------- FERRIPROX is indicated for the treatment of iron overload in patients with thalassemia major when deferoxamine therapy is contra-indicated or inadequate. ------------------------ DOSAGE AND ADMINISTRATION ---------------------- • Starting oral dosage: 75 mg/kg/day (actual body weight) in two divided doses (2.2) • Maximum oral dosage: 99 mg/kg/day (actual body weight) in two divided doses (2.2) ----------------------- DOSAGE FORMS AND STRENGTHS -------------------- • Delayed-release tablets: 1000 mg with functional scoring (3) ------------------------------ CONTRAINDICATIONS ------------------------------- Hypersensitivity to deferiprone or to any of the excipients in the formulations. (4) ------------------------ WARNINGS AND PRECAUTIONS ----------------------- • Liver Enzyme Elevations: Monitor monthly and discontinue for persistent elevations. (5.2) • Zinc Deficiency: Monitor during therapy and supplement for deficiency. (5.3) • Embryo-Fetal Toxicity: Can cause fetal harm. (5.4) ------------------- Přečtěte si celý dokument