MEZAVANT XL GASTRO-RESISTANT PROLONGED RELEASE TABLET 1200MG

4.1 Therapeutic indications

For the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis. For maintenance of remission.

4.3 Contraindications

History of hypersensitivity to salicylates (including mesalazine) or any of the excipients of Mezavant XL.

Severe renal impairment (GFR <30 ml/min/1.73m2) and/or severe hepatic impairment.

4.2 Posology and method of administration

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

For maintenance of remission: 2.4 g (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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).