ACTONORM

Posology Adults, Elderly and children over 12 years One to Four 5ml spoonfuls Children 1 to 12 years One to Two 5ml spoonfuls. To be taken after meals and at night as required Method of administration Oral

Occasional and mild disturbance of bowel function Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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Caution should be exercised when taking magnesium salts in renal failure. Patients should be advised that if symptoms persist for more than 7 days they should consult their doctor. This medicine contains 500mg Propylene Glycol in each 5ml.

Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce serious adverse effects in neonates. Co-administration with any substrate for alcohol dehydrogenase such as ethanol may induce adverse effects in children less than 5 years old.

While propylene glycol has not been shown to cause reproductive or developmental toxicity in animals or humans, it may reach the foetus and was found in milk. As a consequence, administration of propylene glycol to pregnant or lactating patients should be considered on a case by case basis.

Medical monitoring is required in patients with impaired renal or hepatic functions because various adverse events attributed to propylene glycol have been reported such as renal dysfunction (acute tubular necrosis), acute renal failure and liver dysfunction.

This medicine contains 263mg Sorbitol in each 5ml. Sorbitol is a form of fructose. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Sorbitol may cause gastrointestinal discomfort and mild laxative effect.

The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Parahydroxybenzoates may cause allergic reactions (possible delayed).

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