MESASAL Enteric-coated tablet Ref.[50305] Active ingredients: Mesalazine

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2022  Publisher: Viatris Pty Ltd, Level 1, 30 The Bond, 30-34 Hickson Road, Millers Point NSW 2000, www.viatris.com.au, Phone: 1800 274 276

4.1. Therapeutic indications

  • Treatment of acute inflammatory large bowel disease
  • Maintenance therapy of Crohn’s colitis and ulcerative colitis in patients sensitive to sulfasalazine

4.2. Posology and method of administration

In acute ulcerative colitis, remissions will usually occur within 8 weeks.

Adults

Treatment of Acute Ulcerative Colitis and Crohn’s Disease

500 mg (2 × 250 mg tablets) three times daily, (or as directed by a physician). Total daily dose 1.5 g. The tablets should be taken at least 30 minutes before meals with plenty of fluid.

Prevention of Relapses in Ulcerative Colitis

250 mg three times daily.

Maintenance of Remission of Crohn’s Disease

250 mg three times daily.

4.9. Overdose

Symptoms

There is no specific pattern of symptoms following overdose with mesalazine. Possible symptoms may include nausea, vomiting and diarrhoea, and symptoms similar to salicylate overdose.

Treatment

Treatment consists of supportive and symptomatic measures. Further management should be as clinically indicated or as recommended by the national poisons centre, where available. There is no specific antidote.

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

6.3. Shelf life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4. Special precautions for storage

Store below 25°C.

6.5. Nature and contents of container

Container type: blister pack (PVC/PVDC/Al).

Pack sizes: 100

Some strengths, pack sizes and/or pack types may not be marketed.

Australian Register of Therapeutic Goods (ARTG)

AUST R 289132 – MESASAL mesalazine 250mg enteric-coated tablet blister pack.

6.6. Special precautions for disposal and other handling

In Australia, any unused medicine or waste material should be disposed of by taking it to your local pharmacy.

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