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Human medicines European public assessment report (EPAR): Invega, paliperidone, Date of authorisation: 24/06/2007, Revision: 19, Status: Authorised

The most frequent side effects with Invega in adults are headache, insomnia (difficulty sleeping), sleepiness, parkinsonism (effects similar to Parkinson’s disease such as shaking, muscle stiffness and slow movement), dystonia (involuntary muscle contractions), tremor (shaking), dizziness, akathisia (restlessness), agitation, anxiety, depression, increased weight, nausea, vomiting, constipation, dyspepsia (heartburn), diarrhoea, dry mouth, tiredness, toothache, muscle and bone pain, back pain, asthenia (weakness), tachycardia (increased heart rate), high blood pressure, prolonged QT interval (an alteration of the electrical activity of the heart), upper respiratory tract infection (nose and throat infections) and cough. Side effects in adolescents are similar to those in adults, although some side effects may occur more frequently. For the full list of all side effects reported with Invega, see the package leaflet.

Invega must not be taken by people who are hypersensitive (allergic) to paliperidone or any of the other ingredients, or to risperidone.