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en
Worldwide
ROSEMIDE® ODT
PHARMACEUTICAL FORM :
Tablets
ATC class :
AGENTS AFFECTING THE NERVOUS SYSTEM. PSYCHOLEPTICS. ANTIPSYCHOTIC MEDICINES
Active substance :
Risperidone
Composition: :

each tablet contains risperidone 2 mg or 4 mg;

excipients: mannitol (E 421), croscarmellose sodium, ferric oxide red (Е 172), aspartame (Е 951), masking flavor (Powder 599399TP0951), Powdarome peppermint premium, calcium stearate.

Indications for use:
2) Treatment of schizophrenia; 3) treatment of moderate to severe manic episodes associated with bipolar disorders; 4) short-term treatment (up to 6 weeks) of persistent aggression 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 “Administration and dosage” and “Special warnings and precautions for use” sections); 5) short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents.