Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
FERRIC SODIUM CITRATE
EISAI (MALAYSIA) SDN BHD (18039-D)
FERRIC SODIUM CITRATE
100Tablet Tablets
SANNOVA CO LTD
FERROCYTE ® TABLET 50MG Sodium Ferrous Citrate (50mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What _FERROCYTE®_ is used for 2. How _FERROCYTE®_ works 3. Before you use _FERROCYTE®_ 4. How to use _FERROCYTE®_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _FERROCYTE®_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _FERROCYTE®_ IS USED FOR FERROCYTE® is used for patients with iron-deficiency anemia (low levels of red blood cells in the body due to a lack of iron). HOW _FERROCYTE®_ WORKS The absorbed iron enters the body and is used to make hemoglobin, a protein in red blood cells. Sodium ferrous citrate improves anemia (a condition in which there is a deficiency of red cells in the blood, resulting in pallor and weariness) through recovery of hemoglobin level and iron reserve. BEFORE YOU USE _FERROCYTE®_ - _When you must not use it _ _ _ You should not take _FERROCYTE®_ • if you are allergic to any of the ingredients contained in it. • if you are not iron deficient. _ _ _Pregnancy and lactation _ Do not take _FERROCYTE®_ if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take _FERROCYTE®_ if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start use it _ _ _ Before you take FERROCYTE® tablet, tell your doctor if you have: • gastrointestinal diseases such as stomach ulcer, or chronic inflammation of the large intestine and small intestine. • paroxysmal nocturnal hemoglobinuria (rare, acquired, life-threatening disease of the blood characterized by destruction of red blood cells by the complement system, a part of the body's innate immune system). • Received treatment with iron- containing preparation (iron preparation, contrast media of liver for MRI, etc) For elderly patients, this product should be used under careful medical supervision. - _Taking other medicines _ _ _ Tell your doctor or pharma Đọc toàn bộ tài liệu
CONTRAINDICATIONS (FERROCYTE IS CONTRAINDICATED IN THE FOLLOWING PATIENTS.) Patients who are not iron-deficient [Since iron overload may occur, caution should be taken to avoid accidental over- dosing.] DESCRIPTION 1. COMPOSITION Each white, gastric-soluble, film-coated tablet contains 470.9 mg of sodium ferrous citrate (50 mg as elemental iron). It also contains carmellose, microcrystalline cellulose, titanium oxide, calcium stearate, low substituted hydroxypropylcellulose, hydroxypropylcellulose, hypro- mellose and macrogol 6000 as inactive ingredients. 2. PRODUCT DESCRIPTION Brand name Dosage form and identifica- tion code Appearance Description Face Reverse Lateral Ferrocyte Tablets 50 mg Film-coated tablets White S 301 Diameter (mm) 10.3 Weight (mg) 550 Thic kness (mm) 5.0 INDICATIONS Iron-deficiency anemia DOSAGE AND ADMINISTRATION The usual adult dosage for oral use is 100-200 mg as elemental iron (2-4 tablets) daily in one or two divided doses after meals. The dosage may be adjusted depending on the patient’s age and symptoms. PRECAUTIONS 1. CAREFUL ADMINISTRATION (FERROCYTE SHOULD BE ADMINISTERED WITH CARE IN THE FOLLOWING PATIENTS.) (1) Patients with gastrointestinal diseases such as peptic ulcer, chronic ulcerative colitis or focal enteritis [FERROCYTE may aggravate such conditions.] (2) Patients with paroxysmal nocturnal hemoglobinuria [FERROCYTE may induce hemolysis and aggravate the condition.] (3) Patients on therapy with iron-containing preparations (iron preparations, liv- er-specific contrast media for MRI, etc.) [Iron overload may occur.] 2. IMPORTANT PRECAUTIONS Hematological tests should be conducted during treatment with FERROCYTE as necessary to avoid accidental overdosing. 3. DRUG INTERACTIONS Precautions for coadministration (FERROCYTE should be administered with care when coadministered with the following drugs.) DRUGS SIGNS, SYMPTOMS AND TREATMENT MECHANISM AND RISK FACTORS Cefdinir FERROCYTE reduce the absorption of cefdinir to about one tenth, so FER- ROCYTE should be admin- istered Đọc toàn bộ tài liệu