MEZAVANT XL Gastro-resistant, prolonged release tablets Ref.[6971] Active ingredients: Mesalazine

Mezavant XL is intended for once daily, oral administration. The tablets must not be crushed or chewed and should be taken with food.

Adults, including the elderly (>65 years)

For induction of remission: 2.4 to 4.8g (two to four tablets) should be taken once daily. The highest dose of 4.8g/day is recommended for patients not responding to lower doses of mesalazine. When using the highest dose (4.8g/day), the effect of the treatment should be evaluated at 8 weeks.

For maintenance of remission: 2.4g (two tablets) should be taken once daily.

Children and adolescents

Mezavant XL is not recommended for use in children below the age of 18 years due to a lack of data on safety and efficacy.

Specific studies have not been performed to investigate Mezavant XL in patients with hepatic or renal impairment (see sections 4.3 and 4.4).

Mezavant is an aminosalicylate, and signs of salicylate toxicity include tinnitus, vertigo, headache, confusion, drowsiness, pulmonary oedema, dehydration as a result of sweating, diarrhoea and vomiting, hypoglycaemia, hyperventilation, disruption of electrolyte balance and blood-pH and hyperthermia.

Conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage. Hypoglycaemia, fluid and electrolyte imbalance should be corrected by the administration of appropriate therapy. Adequate renal function should be maintained.

2 years.

Store below 25°C.

Store in the original package in order to protect from moisture.

Tablets are packed in polyamide/aluminium/PVC foil blister packs with aluminium push-through foil.

Packs contain 60 or 120 tablets. Not all pack sizes may be marketed.

No special requirements.