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Mesalazine

Film-coated tablets 250 mg        

Film-coated tablets 500 mg

ATC A07E C02

Over the counter medicine

Medicines reimbursed by the Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION


Adults and Elderly

Depending upon the clinical requirements in individual cases, the following daily doses are recommended: – For the treatment of acute episodes: 1.5g to 3.0g mesalazine in three divided doses (3×2 to 3×4 tablets of 250mg daily or 3×1 to 3×2 tablets of 500mg daily). – For the maintenance of remission: 1.5g mesalazine in three divided doses (3×2 tablets of 250mg daily or 3×1 tablets of 500mg daily).

Children

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 is 75 mg/kg/day. The total dose should not exceed the 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 the recommended adult dose. It is generally recommended that half the adult dose may be given to children up to a bodyweight of 40kg and the normal adult dose to those above 40kg.

Method of Administration

Tablets should be taken in the morning, at midday and in the evening, 1 hour before meals. They should be swallowed whole, not chewed, and taken with plenty of fluid.

Tablets should be administered regularly and consistently, both in the acute inflammatory stage and during maintenance therapy in order to achieve the desired therapeutic effect.

The duration of use is determined by the physician. For maintenance of remission in ulcerative colitis, the dose can usually be reduced to 1.5g mesalazine/day (adults and adolescents with bodyweight over 40kg) and 0.75g mesalazine/day (children/adolescents).

MESALAZIN tablets can be used in the therapy of Crohn’s disease when it is located in the colon.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

COMPOSITION

Each film-coated tablet contains 250 mg mesalazine, excipiens.
Each film-coated tablet contains 500 mg mesalazine, excipiens.

THERAPEUTIC INDICATIONS

For the treatment of acute episodes and the maintenance of remission of ulcerative colitis.

CONTRAINDICATIONS

Mesalazine is contraindicated in patients with:
– known hypersensitivity to salicylates or any of the excipients,
– severe impairment of hepatic or renal function.

PACKAGING

Box with 50 film-coated tablets of 250 mg (5 blisters x 10 tablets)
(gastro-resistant tablets with a special film coating, insoluble in acid medium pH 1,2; buffer pH 6,0; but soluble in buffer pH 7,2).