Rilutek

Treatment with RILUTEK should only be initiated by specialist physicians with experience in the management of motor neurone diseases. Posology The recommended daily dose in adults or older people is 100 mg (50 mg every 12 hours). No significant increased benefit can be expected from higher daily doses.

4). Older people Based on pharmacokinetic data, there are no special instructions for the use of RILUTEK in this population. 2. 3 Paediatric population RILUTEK is not recommended for use in paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.

Method of administration Oral use

Summary of safety profile In phase III clinical studies conducted in ALS patients treated with riluzole, the most commonly reported adverse reactions were asthenia, nausea and abnormal liver function tests. Tabulated summary of adverse reactions Undesirable effects ranked under headings of frequency are listed below, using the following convention: 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).

4) Gastrointestinal disorders Nausea Diarrhoea, abdominal pain, vomiting Pancreatitis Skin and subcutaneous tissue disorders Rash Hepato-biliary disorders Abnormal liver function tests Hepatitis General disorders and administration site conditions Asthenia Pain Description of selected adverse reactions Hepato-biliary disorders Increased alanine aminotransferase usually appeared within 3 months after the start of therapy with riluzole; they were usually transient and levels returned to below twice the ULN after 2 to 6 months while treatment was continued.

These increases could be associated with jaundice. 4). 8% (100/5641) of Caucasian patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Liver impairment Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in patients with slightly elevated serum transaminases (ALT/SGPT; AST/SGOT up to 3 times the upper limit of the normal range (ULN)), bilirubin and/or gamma-glutamyl transferase (GGT) levels.

8). Because of the risk of hepatitis, serum transaminases, including ALT, should be measured before and during therapy with riluzole. ALT should be measured every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter.

ALT levels should be measured more frequently in patients who develop elevated ALT levels. Riluzole should be discontinued if the ALT levels increase to 5 times the ULN. There is no experience with dose reduction or rechallenge in patients who have developed an increase of ALT to 5 times ULN.

Readministration of riluzole to patients in this situation cannot be recommended. Neutropenia Patients should be warned to report any febrile illness to their physicians. 8). 8). g. bilateral diffuse lung opacities), riluzole should be discontinued immediately.

In the majority of the reported cases, symptoms resolved after medicinal product discontinuation and symptomatic treatment. 2). Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium free”.

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1. Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal. Patients who are pregnant or breast-feeding.