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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. Elderly: Low initial doses and 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: Normally started at 5mg daily or 0.1 mg/kg/day for younger patients and increased by step of 0.1 to 0.2 mg/kg/day at 7 days intervals, maintenance dose of 0.3-1 mg/kg body weight is usually sufficient. Oral use. Perizam can be taken 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, other than in exceptional cases for anticonvulsant treatment. 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, and behaviour. 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. Excipient warnings: Sodium Methyl parahydroxybenzoate, Sodium Propyl parahydroxybenzoate, Liquid Maltitol and Propylene Glycol. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: Prescription only medicine. Undesirable Effects: Very common: somnolence, fatigue. Common: 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. Uncommon: abnormal behaviour, confusional state, anxiety, delusion, nightmare, loss of libido, emotional poverty, amnesia, memory impairment, anterograde amnesia, diplopia, rash, weight increased, fall. Not known: dependence, initial insomnia, anger, hallucination, psychotic disorder, poor sleep quality, suicidal ideation, cognitive disorder, altered state of consciousness, nystagmus, gait disturbance, respiratory depression, respiratory failure, photosensitivity reaction, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, muscle spasms, muscle weakness, slow response to stimuli, hypothermia. 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: December 2022

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400