Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
FUROSEMIDE POTASSIUM CHLORIDE
Napp Pharmaceuticals Limited
40mg, 600m %v/v
Tablets
1998-01-04
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Diumide-K Continus prolonged release, film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Furosemide 40 mg Potassium Chloride 600 mg (prolonged release). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Prolonged release, film-coated tablets. Orange/white, film coated, bi-layered tablets with the letters ‘DK’ on the orange coloured layer. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the management of fluid retention in which potassium supplementation is required in support of a diuretic administered daily, in mild to moderate hypertension, and in oedema of various aetiologies. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Route of Administration Oral. Adults only The usual dosage is one tablet daily. 4.3 CONTRAINDICATIONS 1. Use of the combination in the presence of hyperkalaemia, precoma associated with hepatic cirrhosis, or Addison’s disease. 2. Use in children. 3. Hypersensitivity to furosemide, potassium chloride or any other constituent of the tablets. 4. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 10/08/2005_ _CRN 2012558_ _page number: 1_ 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 1. Patients who are being treated with this preparation require regular supervision with monitoring of fluid and electrolyte state to avoid inadequate potassium supplementation or excessive loss of fluid. 2. The dosage of potassium supplied with this regimen is not adjusted to the requirements of any patients and the physician Perskaitykite visą dokumentą