Safety-Related Labeling Changes

Sleep-related breathing disorders, Severe cutaneous adverse reactions , Hepatobiliary disorders, Opioid Use Disorder (abuse and dependence) Interactions with gabapentin and pregabalin Central sleep apnoea syndrome, Pancreatitis, Spasm of sphincter of Oddi, Acute generalised exanthematous pustulosis , Drug dependence

Trade Name

Oramorph

Updated Section

4.4 Special Warnings and Special Precautions for Use , 4.5. Interactions with other medicinal products , 4.8 Undesirable effects

Month

Aug,2023