The most common adverse reactions are vomiting, nausea, abdominal pain and headache. Hyponatraemia is rare, but is the most commonly reported serious adverse reaction. Adverse reactions from spontaneous reports are presented by frequency category based on incidence in clinical trials when known. Frequency from spontaneous reports for adverse reactions never observed in clinical trials is based on an algorithm as recommended in the European Commission SmPC guideline, 2009, rev 2. (See table.)
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