EMYLIF

Treatment with riluzole 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). Elderly Based on pharmacokinetic data, there are no special instructions for the use of riluzole in this population. 2 Paediatric population The safety and efficacy of Emylif for the treatment of ALS in the pediatric population have not been established.

No data are available. Method of administration Emylif is for oral administration. • Hands should be clean and dry before handling Emylif so the orodispersible film does not stick to the fingers. • Fold foil sachet along solid line at top.

• While keeping top of sachet folded over at solid line, tear down at the slit along the arrow on the side of the sachet to open. • Remove Emylif orodispersible film from foil sachet. Each sachet contains one dose of Emylif. • Emylif film should not be folded.

• Place Emylif film on top of the tongue, film will stick to the tongue and begin to dissolve. • Once mouth is closed, saliva will normally be swallowed as Emylif dissolves. • Emylif should not be taken with liquids, chewed or spitted.

• Patient should not talk while Emylif dissolves. • After the administration of Emylif, hands should be washed. 4).

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. 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.

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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). Oral hypoesthesia In a single dose study in healthy subjects mild transient oral hypoesthesia has been reported.

Median time to onset was 1 minute from the administration and median duration 40 minutes. 2). The swallowing safety of Emylif has not been evaluated in patients with severe sialorrhea or dysphagia. Caution should be exercised when administering Emylif to these patients.

Fructose Each orodispersible film contains 2 mg. Fructose may damage teeth. This medicinal product contains Sunset yellow FCF (E110), which may cause allergic reactions.

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