Oral solution
ATC class :
Active substance :
Composition: :

1 ml of solution contains risperidone 1 mg;

excipients: tartaric acid, benzoic acid (E 211), sodium hydroxide, purified water.

Indications for use:
• Treatment of schizophrenia and other mental disorders, including maintenance therapy, in responders to prevent recurrence; • short-term treatment (up to 12 weeks) of persistent aggression or severe mental symptoms in patients with moderate to severe Alzheimer’s dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others (see “Special warnings and precautions for use” and “Administration and dosage” sections); • short-term treatment of manic episodes associated with bipolar disorder (adjuvant therapy in combination with normothymics as initial treatment or as monotherapy for up to 12 weeks). For patients who do not respond to treatment, other treatment options should be considered, including discontinuation of risperidone. Treatment can be continued for up to 12 weeks if risperidone is not used in combination with normothymics. Such prolonged treatment should be used to consolidate the patient’s response. In combination with normothymics, risperidone treatment can be discontinued more quickly, because the therapeutic effect of normothymics in combination with risperidone is manifested in the first few weeks of treatment. No relapse prevention studies have been performed. Due to the nature of the disease and the drugs used for treatment, including risperidone, attention should be paid to the occurrence of depression symptoms after the initial response to treatment; • symptomatic treatment of oppositional defiant disorders or other social behavior disorders in children, adolescents and adults with mental development below average or mental retardation, who have manifestations of destructive behavior (impulsivity, autoaggression); • symptomatic treatment of autistic disorders in children over 5 years of age, in which symptoms range from hyperactivity to irritability (including aggression, self-harm, anxiety, and abnormal cyclic actions). Treatment should be initiated and performed under the supervision of an experienced physician. The use of medicines should be part of an integrated approach to treatment, including social and psychotherapeutic treatments.