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National Drug Formulary

ASACOL TABLET 800MG [SIN14275P]

Active ingredients: ASACOL TABLET 800MG

View product's general information
Last updated 24 April 2026

Product Info

ASACOL TABLET 800MG

[SIN14275P]

Product information

Active Ingredient and Strength

MESALAZINE - 800 MG

Dosage Form

TABLET, ENTERIC COATED

Manufacturer and Country

HAUPT PHARMA WULFING GMBH - GERMANY

Registration Number

SIN14275P

Licence Holder

WELLCHEM PHARMACEUTICALS PTE LTD

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

A07EC02

Prescription-only Medicines with Exemptions for Supply without Prescription

NA

Indication

4.1 Therapeutic indications

Asacol is indicated in adults, children and adolescents 6 years of age and older for:

Ulcerative colitis (colitis, rectosigmoiditis and proctitis):
For the treatment of acute exacerbations. For the maintenance of remission.

Dosing

4.2 Posology and method of administration
Posology

Adults
Acute episode: 2.4 g to be taken once daily or in divided doses.
If the clinical picture is especially severe and in cases resistant to treatment, the daily dose may be increased up to 4.8 g a day taken in divided doses.

Maintenance of remission: During the attack-free phase, long-term treatment is indicated to prevent recurrence. 1.6 g to 2.4 g to be taken once daily or in divided doses.

Daily doses of above 2.4 g should be taken in divided doses.

Elderly population
The normal adult dose can be taken unless liver or renal function is severely impaired (see sections 4.3 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). No studies have been carried out in the elderly population.

Paediatric population
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: 75mg/kg/day in divided doses. The total dose should not exceed 4 g/day.

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.

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.

Method of administration: oral.
The tablets must be swallowed whole preferably with some liquid before food intake.

They must not be chewed, crushed or broken before swallowing. If one or more doses have been missed, the next dose is to be taken as usual.

Contraindications

4.3 Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

  • Known hypersensitivity to salicylates.

  • Severe liver impairment.

  • Severe renal impairment (GFR < 30 mL/min/1.73 m2).

  • Do not use in children under the age of 2.