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Epistatus 10mg oromucosal solution SPC updated

4th June 2019

Information has been added to the SPC regarding the risk of use of Epistatus (midazolam) 10mg oromucosal solution in hepatic impairment: Because hepatic impairment reduces the clearance of midazolam and increases the terminal half-life, the clinical effects may be stronger and prolonged. Note. Epistatus is contra-indicated in patients with severe hepatic impairment. Warnings have also been added regarding the increased risk of CNS depression if using opioids concurrently.

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