Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
HYDROTALCITE
Seven Seas Ltd
500 Milligram
Tablets
1998-07-27
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actal 500mg Oral Gum 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One oral gum contains: Hydrotalcite 500 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Oral gum Cream to honey coloured triangular pastille on the surface. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic treatment of heartburn and acid-induced gastric complaints. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS & ADOLESCENTS AGED 13 YEARS AND OVER:_ 1-2 pieces of oral gum to be taken several times a day up to a maximum daily dose of 8 pieces, between meals and before going to bed, or when acid- induced gastric complaints occur (refer to section 4.4). The pieces of oral gum should be chewed well before swallowing. _INFANTS & CHILDREN AGED 12 YEARS AND BELOW:_ Actal Oral Gum is not recommended for use in this age group as no data are available on efficacy and safety. 4.3 CONTRAINDICATIONS Do not use Actal Oral Gum in the presence of hypersensitivity to the active substance or to any of the other excipients, severe renal insufficiency (creatinine clearance < 30ml / min), hypophosphataemia. Patients with rare heredity problems of fructose intolerance should not take this medicine. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE The following special warnings and precautions for use are related to the two major components of hydrotalcite, magnesium and aluminium. Patients with mild to moderate renal insufficiency (creatinine clearance 30 ml/min) should use this product with great caution. Chronic use of hydrotalcite by these patients may cause encephalopathy (aluminium) or hypermagnesaemia (magnesium) in rare cases. IRISH MEDICINES BOARD _____________________________________________________________________________________________ Läs hela dokumentet