Perizam (Clobazam) Abbreviated Prescribing Information

Abbreviated Prescribing Information: Perizam 1mg/ml and 2mg/ml Oral Suspensions Consult Summary of Product Characteristics before prescribing. Presentation: Off-white suspension containing 1mg and 2mg of clobazam per ml respectively. Therapeutic Indications: Short-term symptomatic treatment of anxiety that is severe, disabling or subjecting the individual to unacceptable distress. Short term symptomatic management of hyperarousal & agitation in Schizophrenia. Adjunctive therapy in epilepsy in adults or children >2 Yrs. Posology and Method of Administration: Anxiety: 20-30mg daily in adults, up to maximum of 60mg daily in severe anxiety. In elderly, doses of 10-20mg daily may be used. Epilepsy Adults: Starting dose of 20-30mg/day, increasing as necessary up to maximum of 60mg daily. For elderly patients: Administer low initial doses, with gradual dose increments under careful observation. Hepatic and renal failure: low initial doses and gradual dose increments under careful observation, regardless of the age group. Paediatric population: Epilepsy: Typically initiated at 5mg daily or 0.1 mg/kg/day for younger patients, with an increase of 0.1 to 0.2 mg/kg/day at 7-day intervals. A maintenance dose of 0.3-1 mg/kg body weight is generally adequate. Oral use. Perizam may be administered with or without food. Shake the bottle thoroughly before use. Contra- indications: Hypersensitivity to benzodiazepines or any of the excipients of Perizam. Drug or alcohol dependence. Myasthenia gravis. Severe respiratory insufficiency. Sleep apnoea syndrome. Severe hepatic insufficiencies. Breast-feeding women. Acute intoxication with alcohol and CNS-active substances. Must not be used in children between 6 months and 2 years old, except for rare anticonvulsant treatment. Clobazam is contraindicated during the first trimester of pregnancy. Special Warnings and Precautions for use: In patients with anxiety associated with depression, Perizam must be only used in conjunction with adequate concomitant treatment. Caution must be taken when switching between clobazam products. The duration of treatment should be as short as possible. The following may occur with Perizam and therefore caution is advised: amnesia, psychiatric and ‘paradoxical’ reactions, serious skin reactions, respiratory depression in patients with respiratory insufficiency, muscle weakness, depression and personality disorder, dependence and withdrawal symptoms upon abrupt termination, development of tolerance, psychiatric and paradoxical reactions, suicidal ideation, suicide attempt, and suicide and depression. Benzodiazepines can potentially hinder psychological adjustment in cases of loss or bereavement. Dose reduction may be necessary in patients with renal, hepatic impairment, elderly patients and in patients who are poor metabolisers of CYP2C19. Patient should abstain from drinking alcohol. Dosage adjustment may be necessary in patients using Clobazam concomitantly with cannabidiol-containing products as this may cause somnolence and sedation. Non-medicinal products with Cannabidiol are not recommended to be taken with Clobazam. Any warning from the MC, CHM CSM or MHRA: No . Black Triangle notice: Not applicable. Legal Category: Prescription only medicine. A list of common and serious adverse reactions are somnolence, fatigue, decreased appetite, irritability, aggression, restlessness, depression, drug tolerance, agitation, sedation, dizziness, disturbance in attention, slow speech/dysarthria/speech disorder, headache, tremor, ataxia, dry mouth, nausea, constipation, respiratory depression, respiratory failure, dependence, inappropriate behaviour, suicidal ideation, Stevens-Johnson syndrome, toxic epidermal necrolysis, and cognitive disorder, hallucination, psychotic disorder, suicidal ideation, memory impairment, , and photosensitivity reaction. Refer to the SmPC for full details of other adverse reactions. Pack Size and NHS Price: 1mg/ml – 150ml – £90.00 2mg/ml– 150ml – £95.00. Marketing Authorisation Number 1mg/ml PL00427/0227 and 2mg/ml PL00427/0228. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: February 2025