Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Ferring Ireland Ltd, United Drug House, Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
Mild to moderate ulcerative colitis.
Active disease: Individual dosage, up to 4 g mesalazine once daily or divided into 2-4 doses.
Maintenance treatment: Individual dosage. Recommended dosage, 2 g mesalazine once daily.
The safety and efficacy in children below 6 years of age have not been established. There is only limited documentation for an effect in children (age 6-18 years).
Children 6 years of age and older:
Active disease: To be determined individually, starting with 30-50 mg/kg/day in divided doses. Maximum dose: 75 mg/kg/day in divided doses. The total dose should not exceed 4 g/day (maximum adult dose).
Maintenance treatment: To be determined individually, starting with 15-30 mg/kg/day in divided doses. The total dose should not exceed 2 g/day (recommended adult dose).
It is generally recommended that half the adult dose may be given to children up to a body weight of 40 kg; and the normal adult dose to those above 40 kg.
Oral use.
The granules must not be chewed.
The contents of the sachet should be emptied onto the tongue and washed down with some water or orange juice. Alternatively the entire content of the sachet can be taken with yogurt and consumed immediately.
A single intravenous dose of mesalazine in rats of 920 mg/kg and single oral doses of mesalazine in pigs up to 5 g/kg were not lethal.
There is limited clinical experience with overdose of Pentasa sachet which does not indicate renal or hepatic toxicity. Since Pentasa is an amino salicylate, symptoms of salicylate toxicity may occur. Symptoms of salicylate over dosage are well described in the literature.
There have been reports of patients taking oral daily doses of 8 grams for a month without any adverse events.
There is no specific antidote and treatment is symptomatic and supportive. The treatment at hospital includes close monitoring of renal function.
2 years.
The granules should be used immediately after first opening of the sachet.
This medicinal product does not require any special storage conditions.
Polyester/Aluminium/LD polyethylene sachet.
Pack sizes: 1 × 60, 1 × 120, 1 × 10 sachets.
Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
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