OLSALAZINE SODIUM

Oral. General Olsalazine taken on an empty stomach may sometimes lead to loose stools or diarrhoea. By taking the drug at the end of a meal, this may be avoided.

Acute Mild Disease Adults including the elderly:

Commence on 1 g daily in divided doses taken at the end of meals. Depending on the patient's response, the dose may be titrated upwards over a period of one week to a maximum of 3g daily. A single dose should not exceed 1 g. 5g should be taken twice daily, at the end of meals.

Olsalazine has been used concomitantly with gluco-corticosteroids.

Frequency estimate: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). The most common side effect is diarrhoea which is usually transient.

Where it doesnot, taking the drug at the end of a more substantial meal, dose titration or dose reduction are usually effective. Withdrawal in clinical studies when the drug was taken at the end of meals was around 3%. Where diarrhoea persists, the drug shouldbe stopped.

In addition, the following undesirable effects have been reported:General disorders and administration site conditions: Common: headache Uncommon: pyrexia Blood and lymphatic system disorders: Uncommon: thrombocytopenia Not known: aplastic anaemia, eosinophilia, haemolytic anemia, leukopenia,neutropenia, pancytopenia Gastrointestinal disorders: Common: diarrhoea, nausea Uncommon: vomiting, dyspepsia Not known: abdominal pain upper, pancreatitis Hepatobiliary disorders: Uncommon: hepatic enzyme increased Not known: hepatitis, increased bilirubin Skin and subcutaneous tissue disorders: Common: rash Uncommon: pruritus, alopecia, photosensitivity reaction, urticaria Not known: angioneurotic oedema Cardiac disorders: Uncommon: tachycardia Not known: myocarditis, palpitations, pericarditis Renal and urinary disorders: Not known: interstitial nephritis Respiratory, thoracic and mediastinal disorders: Uncommon: dyspnoea Not known: interstitial lung disease Musculoskeletal and connective tissue disorders: Common: arthralgia Uncommon: myalgia Nervous system disorders: Uncommon: dizziness, paraesthesia Not known: peripheral neuropathy Psychiatric disorders Uncommon: depression Eye disorders: Not known: vision blurred Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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It is recommended to monitor patients with impaired kidney or liver function. Patients suffering from severe allergy or asthma should be observed for signs of worsening of these conditions. Baseline renal function measurement is required in all patients initiating treatment with olsalazine.

For patients with baseline renal impairment, treatment with olsalazine should only be initiated if the benefits are considered to outweigh risk. In addition, periodic renal function monitoring, especially in the early months of treatment, should be conducted based on clinical judgment taking baseline renal function into account.

It is recommended to monitor renal function in patients receiving olsalazine, by estimating serum creatinine before treatment, every 3 months for the first year, every6 months for the next 4 years, and annually after 5 years of treatment.

Treatment should be discontinued if renal function deteriorates. Serious blood dyscrasias have been reported very rarely with olsalazine. Treatment should be stopped if there is a suspicion or evidence of a blood dyscrasia. Patients or their carers should be instructed how to recognise the signs of haematotoxicity and should be advised to contact their physicians immediately if thesymptoms develop.

1. There is no experience of the use of olsalazine in patients with significant renal impairment. Olsalazine is contra-indicated in patients with significant renal impairment.