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: 20–30 mg daily in adults, up to a maximum of 60 mg daily in severe anxiety. The lowest effective dose should be used and patients should be re‑evaluated regularly. Treatment duration should not exceed 4 weeks (including tapering off period). In elderly, doses of 10–20 mg daily may be used. Epilepsy Adults: Starting dose 20–30 mg/day, increasing as necessary up to a maximum of 60 mg 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. Prior to starting treatment, a strategy for ending treatment should be discussed with the patient to minimise the risks of dependence, addiction and withdrawal syndrome. 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 exceptional situations. 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. Benzodiazepines should not be used alone in such patients as they may precipitate suicide. Caution must be taken when switching between clobazam products, as increased plasma levels may occur when switching from tablet to oral suspension, potentially increasing the risk of respiratory depression and sedation The duration of treatment should be as short as possible. The following may occur and therefore caution is advised: amnesia, psychiatric and ‘paradoxical’ reactions, serious skin reactions, respiratory depression, muscle weakness, depression and personality disorder, dependence, addiction and withdrawal syndrome, development of tolerance, suicidal ideation, suicide attempt and suicide. Prolonged use may lead to drug dependence and addiction, even at recommended doses. The risk increases with dose and duration of treatment and in patients with a history of substance misuse or mental health disorders. A withdrawal strategy should be discussed before starting treatment and doses should be tapered gradually. Concomitant use with opioids may result in sedation, respiratory depression, coma and death. Co‑prescribing should only be considered when alternative options are not possible. The lowest effective dose should be used for the shortest duration and patients should be closely monitored. Patients should be monitored for signs of misuse, abuse or addiction. Overuse or misuse may result in overdose and/or death. Respiratory function should be monitored in patients with respiratory insufficiency and dose reduction may be required. Dose reduction may be necessary in patients with renal or hepatic impairment, elderly patients, and in patients who are poor metabolisers of CYP2C19; increased exposure to the active metabolite may occur in such patients. Patients should abstain from alcohol. Dosage adjustment may be necessary when clobazam is used concomitantly with cannabidiol-containing products, as increased sedation may occur. Non‑medicinal cannabidiol products are not recommended. Any warning from the MC, CHM CSM or MHRA: No. Black Triangle notice: Not applicable. Legal Category: Prescription only medicine. A list of very common, common and serious adverse reactions: 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,  Serious; 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. drug dependence, withdrawal syndrome, altered state of consciousness, behavioural disturbances and initial insomnia. Adverse reactions may occur more frequently at the beginning of treatment or with higher doses (e.g. somnolence, fatigue). 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: May 2026