TEGLUTIK

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

e. 10 ml corresponds to 50 mg of Riluzole).

Special populations Paediatric population:

TEGLUTIK 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. 4). Older people: based on pharmacokinetic data, there are no special instructions for the use of TEGLUTIK in this population.

2. Method of administration The suspension can be given per oral administration and alternatively it is also suitable for administration via enteral feeding tubes. Dilution with liquids is not necessary. The suspension is administered by means of graduated dosing syringe.

6.

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 administratio n 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. 2). g. dizziness, diarrhoea, asthenia and ALT increase) with the oral suspension. 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. uk/yellowcard.

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 drug discontinuation and symptomatic treatment.

2). This medicine contains 4000 mg sorbitol (E420) in 10 ml of oral suspension. The additive effect of concomitantly administered products containing sorbitol and dietary intake of sorbitol should be taken into account. The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.

Patients with hereditary problems of fructose intolerance should not take this medicine. This medicine contains less than 1 mmol sodium(23 mg) per 10 ml of oral suspension, that is to say essentially ‘sodium-free’.

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