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Author: Admin | 2025-04-28
Of 5 studies in 1,900 adults, Abilify was more effective than placebo at reducing manic symptoms, with two of these studies showing that Abilify has a similar effect to haloperidol and to lithium. Other studies showed that Abilify was more effective than placebo at preventing manic episodes in previously treated adults for up to 74 weeks, and when it was used as an add-on to existing treatment.A study in 296 children and adolescents showed that Abilify was more effective than placebo at reducing the manic symptoms in patients aged 13 years and older.Finally, a study in 291 patients treated by injection for agitation and disturbed behaviour showed that improvement with Abilify was greater after 2 hours than with placebo and similar to that with lorazepam (another medicine for treating agitation).In adults, the most common side effects when taking Abilify by mouth (occurring in up to 10 patients in 100) are restlessness, difficulty sleeping, anxiety, extrapyramidal disorder (uncontrolled twitching or jerking), akathisia (a constant urge to move), tremor (shaking), dizziness, sleepiness, headache, blurred vision, dyspepsia (heartburn), vomiting, nausea (feeling sick), constipation, salivary hypersecretion (increased production of saliva), tiredness and diabetes. The side effects are similar in adolescents, but sleepiness, extrapyramidal disorder, akathisia and tiredness are very common in this group (in more than 1 in 10 adolescents).The most common side effects with the injection (occurring in up to 10 patients in 100) are sleepiness, dizziness and nausea. For the full list of all side effects and restrictions, see the package leaflet.Studies comparing Abilify to placebo or other medicines (such as haloperidol and lithium) show that Abilify is effective at reducing symptoms of schizophrenia and at treating and preventing high moods in patients with bipolar I disorder.In addition, the injection has been shown to be effective at quickly controlling agitation or disturbing behaviour in patients with schizophrenia or bipolar I disorder.With regard to safety, the medicine has side effects comparable to those of other antipsychotics. The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that the benefits of Abilify are greater than its risks and recommended its approval in the EU.Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abilify have been included in the summary of product characteristics and the package leaflet.The European Commission granted a marketing authorisation valid throughout the European Union for Abilify on 4 June 2004.Product informationLatest procedure affecting product information: IB/0140 28/03/2022 This medicine’s product information is available in all official EU languages.Select 'available languages' to access the language you need.Product information documents contain:summary of product characteristics (annex I);manufacturing authorisation holder responsible for batch release (annex IIA);conditions of the marketing authorisation (annex IIB);labelling (annex IIIA);package
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