Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FERROUS GLUCONATE
Clonmel Healthcare Ltd
300 Milligram
Coated Tablets
1988-05-11
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ferrous Gluconate 300mg Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Ferrous Gluconate 300mg. 300mg Ferrous Gluconate contains approximately 35mg of iron. Each tablet also contains the excipients: Sucrose 117.56mg Ponceau 4R Red (E124) 3.63mg _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Coated tablet (tablet) Red, circular, biconvex, sugar coated tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention and treatment of iron deficiency states. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Prevention of iron defiencey anaemia:- 2 tablets daily before food. Treatment of iron deficiency anaemia:- 4-6 tablets daily in divided doses before food. Route of administration Oral 4.3 CONTRAINDICATIONS Use in patients known to have hypersensitivity to the active ingredient. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. The absorption of iron salts is decreased in the presence of antacids. 2. This product should be used with caution in patients with haemochromatosis and haemolytic anaemias. 3. This product should only be used for the treatment of iron deficiency anaemia diagnosed by laboratory testing under the supervision of a medical doctor. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/05/2010_ _CRN 2083006_ _page number: 1_ 4. This medicinal product contains Sucrose. Patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. 5. This medicinal product contains Ponceau 4R Red (E124), which may cause allergic reactions. 4.5 INTERACTION WITH OTHER MEDICIN Read the complete document