Clobazam 20 mg tablets Prescribing Information |
Presentation: Each tablet contains 20mg clobazam. Also contains 137.60 mg of lactose (as lactose monohydrate) and 36.08 mg of lactose (as anhydrous lactose). Indications: For the short-term relief (2 – 4 weeks) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness. Patients with anxiety associated with depression, clobazam must be used only in conjunction with adequate concomitant treatment. In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive. May be used as adjunctive therapy in epilepsy. Dosage and administration: Treatment of anxiety: 20-30 mg daily in divided doses or as a single dose given at night. Up to 60 mg used in treatment of adult in-patients with severe anxiety. Should use lowest dose that can control symptoms. After improvement, the dose may be reduced. Should not be used for longer than 4 weeks. Avoid prolonged periods of uninterrupted treatment. Treatment of epilepsy in association with one or more other anticonvulsants: Starting dose of 20-30 mg/day. Up to a maximum of 60mg daily. Special Populations: Paediatric population aged 6 years and above: Starting dose at 5mg daily. Maintenance dose of 0.3 – 1 mg/kg body weight daily. Elderly: 10-20 mg daily in anxiety. Requires low initial doses and gradual dose increments under careful observation. Renal and hepatic impairment: dose reduction may be necessary depends on susceptibility to adverse effects. In long term treatment renal and hepatic function must be checked regularly. Method of Administration: Can be administered whole, or crushed and mixed in apple sauce. Tablets can be divided into equal doses and it can be given with or without food. Fertility, pregnancy and lactation: Should not be used during pregnancy and in women of childbearing potential who are not using effective contraception. Should not be given to breastfeeding mothers. Fertility: No clinical data is available. Contraindications: Must not be used in patients: with known hypersensitivity to benzodiazepines the excipients, with any history of drug or alcohol dependence, with myasthenia gravis, with severe respiratory insufficiency, with sleep apnoea syndrome, severe hepatic insufficiencies, during first trimester of pregnancy, breast-feeding women. Must not be given to children without careful assessment of the need for their use. Clobazam must not be used in children 6 months -3 years, other than in exceptional cases for anticonvulsant treatment where there is a compelling indication. Special warnings and precautions: Amnesia may occur. Can cause muscle weakness. Some epidemiological studies suggest an increased incidence of suicidal ideation. of suicidal ideation, suicide attempt and suicide in patients with or without depression and treated with benzodiazepines and other hypnotics, including clobazam. However, a causal relationship has not been established Suicide may be precipitated in patients who are depressed and aggressive behaviour towards self and others may be precipitated. Extreme caution should therefore be used in patients with personality disorders. Dependence: Risk of dependence increases with dose and duration of treatment. A withdrawal syndrome may occur when abruptly changing from a benzodiazepine with long duration of action (such as clobazam) to one with a short duration of action. Serious skin reactions: Including Stevens-Johnson syndrome and toxic epidermal |
necrolysis (TEN) have been reported. Respiratory depression: Should be monitored in patients with chronic or acute severe respiratory insufficiency and a dose reduction may be necessary. Tolerance in epilepsy: Possibility of a decrease in anticonvulsive therapy. CYP2C19 Poor metabolisers: dose adjustment may be necessary. Alcohol: Increase risk of sedation and other adverse effects. Concomitant use of opioids and benzodiazepines: may result in sedation, respiratory depression, coma, and death. If no alternative options are available, prescribe the lowest effective dosages and minimum durations of concomitant use. Concomitant use of cannabidiol and clobazam increases the incidence of somnolence and sedation. Reduction in dose of clobazam should be considered. Non-medicinal products containing cannabidiol must not be taken in combination with clobazam as they contain unknown quantities of cannabidiol and are of variable quality. Lactose: should not be taken by patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Drug Interactions: Alcohol, central nervous system depressant drugs, concomitant use of benzodiazepines, anticonvulsants, concomitant use of narcotic analgesics, muscle relaxants, strong and moderate inhibitors of CYP2C19 (e.g. fluconazole, fluvoxamine, ticlopidine, omeprazole), cannabidiol, CYP2D6 substrates (dextromethorphan, pimozide, paroxetine, nebivolol). Effects on ability to drive/use machines: Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the ability to drive or to use machines. . If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased. Clobazam is on the list of drugs included in regulations under 5a of the Road Traffic Act 1988. Undesirable effects: decreased appetite, irritability, aggression, restlessness, depression, drug tolerance, agitation, abnormal behaviour, confusional state, anxiety, delusion, nightmare, loss of libido, dependence, anger, hallucination, psychotic disorder, suicidal ideation, somnolence, sedation, dizziness, disturbance in attention, slow speech/dysarthria/ speech disorder, headache, tremor, ataxia, amnesia, cognitive disorder, altered state of consciousness, diplopia, respiratory depression, respiratory failure, dry mouth, nausea, constipation, photosensitivity reaction, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, fatigue, fall. See SmPC for full list of adverse events. Pack size and UK list price: Clobazam 20 mg tablets (PL 25298/0242) pack size: 30’s, £ 9.75. Legal category: POM Marketing Authorisation Holder: Brown & Burk UK Ltd, 5 Marryat Close, Hounslow West, Middlesex, TW4 5DQ, United Kingdom Distributor: Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom Date of Preparation: Jun 2024 Ref: 000666766 |