Product Name & Strength: Emzor Paediatric Zinc Sulphate Tablet, 20 mg (1 x 10's).
Indications (Approved Uses): Indicated for the treatment of acute and persistent diarrhoea in infants and children up to 5 years of age.
Contraindications (Safety Warnings): Emzor Paediatric Zinc Sulphate Tablets contain aspartame, a source of phenylalanine; this should be considered when prescribing the product to patients with phenylketonuria. Do not co-administer with drugs that inhibit zinc absorption such as penicillamine, sodium valproate, and ethambutol, unless the risks of discontinuation of the drug are judged to outweigh the benefit of zinc in the treatment of the child's diarrhoea. Avoid co-administration with tetracyclines (but not doxycycline), quinolone antibiotics, cephalexin, or ceftibuten; an interval of at least three hours should be allowed between the administration of zinc and any of these medicines.
Side Effects (Adverse Reactions): Administration is commonly associated with vomiting or regurgitation, usually occurring shortly after the first dose. Zinc salts may also cause abdominal pain and dyspepsia.
Nutritional Information (per Tablet): Zinc Sulfate Monohydrate 54.9 mg (equivalent to 20 mg of elemental zinc), aspartame 46.435 mg, colloidal anhydrous silica, ethyl vanillin, magnesium stearate, maize starch, microcrystalline cellulose.
Instructions for Use / Dosage: For oral administration. For children less than 6 months of age, administer ½ tablet once daily. For children 6 months of age to 5 years of age, administer 1 tablet once daily. Duration of treatment is 10-14 days. The tablet or half-tablet should be dispersed completely in 1 teaspoon (5 ml) of clean water or breast milk and the entire amount administered orally. It is recommended that doses be administered between meals.
Regulatory Information: NAFDAC Registration Number: 04-8512. Manufactured by: Emzor Pharmaceutical Industries Limited.
