MECOLZINE Gastro-resistant tablet Ref.[50654] Active ingredients: Mesalazine

Posology

During the acute inflammatory phase and in long-term maintenance therapy, the patient must accurately follow the treatment established by the doctor to ensure the intended therapeutic effect.

Adults

The dosage should be adjusted according to patient response. The following dosage is recommended:

• Ulcerative colitis (acute phase): 1,5-4 g mesalazine daily, once daily or in divided doses. The dose of 4 g is recommended for patients who do not respond to lower doses of mesalazine. The effect of the treatment should be evaluated 8 weeks after initiation.
• Ulcerative colitis (maintenance): 1,5–3 g mesalazine daily, once daily or in divided doses. The dose of 3 g is recommended for patients who do not respond to lower doses of mesalazine and for those who required higher doses during acute phase.

Elderly

No studies have been carried out. Administration of Mecolzine 500 mg gastro-resistant tablets in the elderly must be performed with caution and always limited to patients with normal renal function.

Paediatric population

The safety and efficacy of Mesalazine in children and adolescents aged younger than 18 years of age has not been established. Do not administer to children under 5 years.

Method of administration

Oral use

The tablets must be administered before meals and must be taken whole with some fluid.

Mesalazine 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.

There is no specific antidote for mesalazine overdose and treatment is symptomatic and supportive. 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.

This medicinal product does not require any special storage conditions.

Aluminium/Aluminium blister packed in cartons containing 100 tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.