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Chlorpromazine Hydrochloride Abbreviated Prescribing Information

Abbreviated Prescribing Information: Chlorpromazine Hydrochloride 25mg/5ml and 100mg/5ml Oral Syrup. Consult Summary of Product Characteristics before prescribing. Presentation: Oral Solution containing either 25mg/5ml or 100mg/5ml Chlorpromazine Hydrochloride. Therapeutic Indications: Schizophrenia and other psychoses (especially paranoid), mania and hypomania; as an adjunct in psychomotor agitation, excitement and violent or dangerously impulsive behaviour; nausea and vomiting of terminal illness; childhood schizophrenia and autism; intractable hiccups. Posology and Method of Administration: Dosage for schizophrenia, other psychoses, mania, hypomania, anxiety, psychomotor agitation, excitement, violent or dangerously impulsive behaviour: Initially 25mg three times daily or 75mg at bedtime increasing daily by 25mg to maintenance dose 70 to 300mg, but may be up to 1g daily in some patients. Elderly or disabled patients: Start with 1/3 to 1/2 the usual adult dose with a more gradual increase in dosage. Dosage for Intractable Hiccup: 25 – 50mg tds or qds. Dosage for Vomiting and Nausea of Terminal Illness 10 – 25mg every 4 – 6 hours. Elderly or disabled patients: Initially 1/3 to 1/2 the adult dose. Paediatric population: Childhood schizophrenia Children under 1 year: Not recommended unless the need is lifesaving. Children 1 – 5 years: 0.5mg/Kg bodyweight every 4 – 6 hours to a maximum of 40mg daily. Children 6 – 12 years: 1/3 to 1/2 the adult dose up to a maximum of 75 mg daily. Dosage for Intractable Hiccup: Not recommended. Vomiting and Nausea of Terminal Illness: Children under 1 year: Do not use unless need is lifesaving. Children 1 – 5 years: 0.5mg/Kg every 4 – 6 hours. Maximum daily dosage 40 mg. Children 6 – 12 years: 0.5mg/Kg every 4 – 6 hours. Maximum daily dosage 75mg. Contra-indications: Hypersensitivity to chlorpromazine or to any of the excipients, comatose states, severe CNS depression, •history of blood dyscrasias including bone marrow depression and agranulocytosis, severe cardiovascular disease, risk of angle-closure glaucoma, risk of urinary retention related to urethroprostatic disorders, dopaminergic antiparkinsonism agents, nursing mothers, and citalopram and escitalopram. Special Warnings and Precautions for use: Caution in patients with cardiac arrhythmias, cardiac disease, severe respiratory disease, renal failure, Parkinson’s disease, history of narrow angle glaucoma, prostatic hypertrophy, epilepsy, myasthenia gravis, phaeochromocytoma and hypersensitivity to phenothiazines. Caution in the elderly, as they are particularly susceptible to postural hypotension, sedation, extrapyramidal effects, chronic constipation, and potentially prostatic hypertrophy. Close monitoring is required in patients with epilepsy or a history of seizures. Avoid in patients with liver dysfunction, hypothyroidism, cardiac failure and agranulocytosis. In patients with impaired liver function, regular monitoring is necessary. If signs of blood dyscrasia appear, regular blood counts should be carried out. All patients with blood disorder must be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count. Treatment will be discontinued if any marked changes are observed. Withdrawal should be gradual and closely monitored. In schizophrenia, the response may be delayed. Conversely, if treatment is withdrawn, the recurrence of symptoms may not become apparent for some time. Treatment to be discontinued in the event of signs of neuroleptic malignant syndrome. Chlorpromazine should not be used alone where depression is predominant. Patients should be advised to avoid exposure to direct sunlight. Care must be taken to avoid contact of the drug with the skin. Chlorpromazine should be used with caution in patients with risk factors for stroke. May potentiate QT interval prolongation. The absence of any factors favouring the onset of ventricular arrhythmias should be ensured before administration. It is recommended that the initial work up of patients should include an ECG. All possible risk factors for VTE should be identified before and during treatment with chlorpromazine and preventive measures undertaken. Except under exceptional circumstances, this drug must not be administered to patients with Parkinson’s disease. Use with lithium, other QT prolonging agents, and dopaminergic anti-parkinsonism agents is not recommended. The onset of paralytic ileus must be treated as an emergency. Use with other neuroleptics should be avoided. Elderly Patients with Dementia: Elderly patients with dementia-related psychosis treated with antipsychotics drugs are at an increased risk of death. Chlorpromazine is not licensed for the treatment of dementia-related behavioural disturbances. Hyperglycaemia or intolerance to glucose has been reported. Patients with an established diagnosis of diabetes mellitus or with risk factors for the development of diabetes should get appropriate glycaemic monitoring during treatment. Patients are strongly advised not to consume alcohol and alcohol-containing drugs throughout treatment. Children should undergo a yearly clinical examination to evaluate learning capacity. Severe liver toxicity, resulting sometimes in death, has been reported with chlorpromazine use. Drug reaction with eosinophilia and systemic symptoms (DRESS) can be life-threatening or fatal, have been reported in association with chlorpromazine treatment. If signs and symptoms suggestive of these reactions appear, chlorpromazine should be withdrawn immediately and not be restarted. Any warning from the MC, CHM CSM or MHRA. Black Triangle notice: Not applicable. Legal Category: POM. A list of very common and common reactions is presented below and refer the SmPC for other reactionsVery common: Weight increased, sedation, somnolence, dyskinesia (Acute dystonias or dyskenias, usually transitory are more common in children and young adults and usually occur within the first 4 days of treatment or after dosage increases), tardive dyskinesia, extrapyramidal disorder, akathisia-often after large initial dose, orthostatic hypotension, dry mouth, constipation. Common: Hyperprolactinaemia, amenorrhoea, glucose tolerance impaired, anxiety, hypertonia, convulsion, ECG changes include Electrocardiogram QT prolonged, ST depression, and U-Wave and T-Wave changes. Pack Size and NHS Price: 25mg/5ml 150ml – £2.35 and 100mg/5ml 150ml – £5.50. Marketing Authorisation Number: 25mg/5ml PL 0427/5017R and 100mg/5ml PL 00427/0072. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: 20 October 2023.

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