PENTASA Suppository Ref.[6972] Active ingredients: Mesalazine

Adults

Active treatment: 1 g mesalazine twice daily for two to four weeks.

Maintenance treatment: 1-2 g mesalazine daily.

Paediatric population

There is little experience with only limited documentation for an effect in children.

Acute experience in animals

Single oral doses of mesalazine of up to 5 g/kg in pigs or a single intravenous dose of mesalazine at 920 mg/kg in rats were not lethal.

Human experience

There is limited clinical experience with overdose of Pentasa which does not indicate renal or hepatic toxicity. But since Pentasa is an amino salicylate, symptoms of salicylate toxicity such as acid-base balance disorder, hyperventilation, pulmonary oedema, vomiting, dehydration and hypoglycaemia may occur. Symptoms of salicylate over dosage are well described in the literature.

There have been reports of patients taking daily doses of 8 grams for a month without any adverse events.

There is no specific antidote and the management of overdose is supportive and symptomatic. The treatment at the hospital includes close monitoring of renal function.

3 years.

Do not store above 25°C. Store in the original package in order to protect from light.

Each suppository is individually packed in double aluminium foil and presented in cartons of 28 suppositories.

No special requirements.