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Clonazepam Abbreviated Prescribing Information

Abbreviated Prescribing Information: Clonazepam Rosemont 0.5mg/5ml and 2mg/5ml Oral Solutions. Consult Summary of Product Characteristics before prescribing. Presentation: Clear pale straw coloured oily solutions; each 5ml of solution contains either 0.5mg or 2mg clonazepam. Therapeutic Indications: Treatment of all clinical forms of epileptic disease and seizures in adults. Posology and Method of administration: Adults: Initial dosage should not exceed 1mg/day. Maintenance dosage normally falls within 4-8mg. Elderly: Recommend initial dosage should not exceed 0.5mg/day. Total daily dosages should be divided into 4 doses taken at intervals throughout the day. It is at the discretion of the physician should a larger dose be given, up to a maximum of 20mg/day. Attain maintenance dose after 2-4 weeks of treatment. Paediatric population: Not indicated. Pack includes 2.5ml/ 5ml double ended spoon with a further 1.25ml graduation. Suitable for administration via non-PVC nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes. Incompatible with polystyrene or PVC. Once the maintenance dose level has been reached, the daily amount may be given in a single dose in the evening. Use of multiple anticonvulsants may result in an increase of undesired effects. Contra-indications: Sensitivity to benzodiazepines or to any of the excipients; acute pulmonary insufficiency, severe respiratory insufficiency, sleep apnoea syndrome, myasthenia gravis, severe hepatic insufficiency. It must not be used in patients in a coma, or in patients known to be abusing pharmaceuticals, drugs or alcohol. Special Warnings and Precautions for use: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents. Use with caution, and generally reduce dosage, in patients with chronic pulmonary insufficiency, or with impairment of renal or hepatic function and in the elderly or the debilitated. Treatment must be withdrawn by gradual dose reduction. This precaution should also be taken when withdrawing another drug while the patient is receiving clonazepam. Prolonged use may result in dependence development with withdrawal symptoms on cessation. Clonazepam may only be used in particular caution in patients with spinal or cerebellar ataxia, in the event of acute intoxication with alcohol or drugs and in patients with severe liver damage. Use with extreme caution in patients with a history of alcohol or drug abuse. Dosage should be carefully adjusted in patients with pre-existing disease of the respiratory system or liver and in patients undergoing treatment with other centrally acting medications or anticonvulsant agents. Clonazepam may modify the patient’s reactions. In cases of loss or bereavement, psychological adjustment may be inhibited. Use of benzodiazepines may lead to the development of physical and psychological dependence. Use with opioids may result in sedation, respiratory depression, coma and death. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: Prescription only medicine. Undesirable Effects: Allergic reactions and very few cases of anaphylaxis and angioedema. Reversible: development of premature secondary sex characteristics in children. Impaired concentration, restlessness, confusional state, disorientation and depression. Paradoxical reactions: excitability, irritability, aggression, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares, vivid dreams and psychotic disorders and activation of new types of seizures may be precipitated. Rare: loss of libido. Beneficial effect on behaviour disturbances in epileptic patients. Frequent: Somnolence, slowed reaction, muscular hypotonia, dizziness, ataxia, light-headedness, co-ordination disturbances, fatigue and muscle weakness. Rare: Headache, generalized fits. Reversible (long term or high dose): dysarthria, ataxia and nystagmus. At therapeutic dose: Anterograde amnesia, increased risk at higher doses. Amnestic effects may be associated with inappropriate behaviour. Reversible (long term or high does): diplopia. Common: nystagmus. Cardiac failure including cardiac arrest has been reported. Rare: respiratory depression. In infants and small children, and particularly those with a degree of mental impairment, clonazepam may give rise to salivary or bronchial hypersecretion with drooling. Supervision of the airway may be required. Rare: nausea, gastrointestinal and epigastric symptoms. Rare: urticaria, pruritus, rash, transient hair loss, pigmentation changes and angioedema. Frequent: Muscle weakness, transient. Rare: urinary incontinence, erectile dysfunction, loss of libido and impotence. Frequent (transient and generally disappears in the course of the treatment or dose reduction): Fatigue. Paradoxical reactions: irritability. Reports of falls and fractures in benzodiazepine users. Rare: decreased platelet count. Isolated cases of blood dyscrasias and abnormal liver function tests. Rare: may induce convulsions in patients with porphyria. Pack Size and NHS Price: 0.5mg/5ml 150ml- £69.50, 2mg/5ml 150ml- £90.30. Marketing Authorisation Number: UK: 0.5mg/5ml – PL 00427/0157and 2mg/5ml – PL 00427/0158, IE: 0.5 mg/5ml: PA23081/009/001. 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