SPC changes
Comtess tablets
The summary of product characteristics for Comtess (entacapone) tablets
has been updated (Orion Pharmaceuticals). It now states that entacapone
in association with levodopa has been associated with somnolence and
episodes of sudden onset of sleep in patients with Parkinson’s
disease, so caution should be exercised when driving or operating machines.
Monitoring of weight is recommended in patients with diarrhoea in order
to avoid potential excessive weight decrease. Anorexia and weight decrease
have been added as very rare adverse reactions. See SPC.
Angettes 75
The summary of product characteristics for Angettes 75 (aspirin 75mg)
now states “Do not give to children aged under 16 years, unless
specifically indicated (eg for Kawasaki’s disease)” (Bristol-Myers
Squibb). Additional information regarding the risk of Reye’s
syndrome has been included. See SPC. The patient information leaflet
has been amended accordingly.
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