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Benzisox Product Information Leaflets
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Benzisox (Risperidone) is a novel antipsychotic belonging to a new class of antipsychotic agents, the benzisoxazole derivates.


Benzisox 1 mg tablets: Each film coated tablet contains Resperidone 1mg. Benzisox 2 mg tablets: Each film coated tablet contains Resperidone 2mg. Benzisox 3 mg tablets: Each film coated tablet contains Resperidone 3mg. Benzisox 4 mg tablets: Each film coated tablet contains Resperidone 4mg.


tBenzisox is indicated for the treatment of a broad range of patients with schizophrenia, including first episode psychosis, acute schizophrenic exacerbations, chronic schizophrenia and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted affect emotional and social withdrawal, poverty of speech) are prominent. Benzisox alleviates affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia. Benzisox is also effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. In addition, Benzisox is indicated for the treatment of behavioral disturbances in patients with dementia in whom symptoms such as aggressiveness (verbal outbursts, physical violence), activity disturbances (agitation wandering) or psychotic symptoms are prominent. Benzisox is also indicated as adjunctive therapy to mood stabilizers in the treatment of manic episodes associated with bipolar disorders. These episodes are characterized by symptoms such as elevated, expansive or irritable mood, inflated self esteem, decreased need for sleep, pressured speech, racing thoughts, distractibility or poor judgment including disruptive or aggressive behaviour. Benzisox is indicated in the treatment of conduct and other disruptive behaviour disorders in children, adolescents and adults with sub average intellectual functioning or mental retardation in whom destructive behaviour (e.g., Aggression, impulsivity and self- injurious behaviour) are prominent.


a. Schizophrenia Adults Benzisox may be given once daily or twice daily. Patients should start with Benzisox 2 mg/day. The dosage may be increased on the second day to 4 mg. From then on the dosage can be maintained unchanged, or further individualized, if needed. Most patients will benefit from daily doses between 4 and 6 mg. In some patients a slower titration phase and a lower starting and maintenance dose may be appropriate. Doses above 10 mg/day have not been shown to be superior in efficacy to lower doses and may cause extrapyramidal symptoms since the safety of doses above 16 mg/day has not been evaluated, doses above this level should not be used. A benzodiazepine may be added to Benzisox when additional sedation is required.


Benzisox is contraindicated in patients with known hypersensitivity to the product.


1. Benzisox 1 mg tablets: Blister pack of 1X20 film coated tablets. 2. Benzisox 2 mg tablets: Blister pack of 1X20 film coated tablets. 3. Benzisox 3 mg tablets: Blister pack of 1X20 film coated tablets. 4. Benzisox 4 mg tablets: Blister pack of 1X20 film coated tablets.


The safety of risperidone for use during human pregnancy has not been established. Although, in experimental animals risperidone did not show direct reproductive toxicity, some indirect, prolactin and CNS-mediated effects were observed. No teratogenic effect of risperidone was noted in any study. Therefore, risperidone should only be used during pregnancy if the benefits outweigh the risks. In animaW>tudies, risperidone and 9- hydroxy-risperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxy- risperidone are also excreted in human breast milk. Therefore, women receiving risperidone should not breastfeed.

Patients should consult with their physician before taking any medicine.