In this guide the patient is warned about the risks (of respiratory and central nervous system depression, depression, suicide, seizures, abuse, misuse, illicit and criminal use, overdose, dependence/addiction and the interaction of the product with alcohol and the resulting psychosis) and is told how to proceed in the event of experiencing them.

Guidance for paediatric patients and their caregivers - Important information about safe use and handling of Sodium Oxybate 500 mg/ml oral solution (sodium oxybate).

IMPORTANT RISK MINIMISATION INFORMATION FOR PATIENTS:

How to take SODIUM OXYBATE 500mg/ml Oral solution

This treatment initiation form should be completed by Healthcare Professionals as it is essential to ensure the safe and effective use of Sodium Oxybate 500 mg/ml oral solution and the appropriate management of the important risks. All sections of this form need to be completed, signed and dated and retained in the patient's medical records.

This guide contains recommendations to minimise the risks of respiratory and central nervous system depression, depression, suicide, seizures, abuse, misuse, illicit and criminal use, overdose, dependence/addiction and the interaction of the product with alcohol and the resulting psychosis.

This guide contains recommendations to avoid the risks (respiratory and central nervous system depression, depression, suicide, seizures, abuse, misuse, illicit and criminal use, overdose, dependence/addiction and the interaction of the product with alcohol and the resulting psychosis) and patients are advised to carry this with them at all times.