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 severe anxiety, 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: Treatment should begin with a low dose and be gradually increased under close supervision to reach an optimal level. For adults with schizophrenia, psychoses, mania, or related conditions, the starting dose is typically 25 mg three times daily or 75 mg at bedtime, increasing by 25 mg daily to a maintenance dose of 70–300 mg/day, potentially up to 1 g/day. For intractable hiccup, adults may take 25–50 mg three or four times daily. In cases of vomiting and nausea due to terminal illness, adults are dosed at 10–25 mg every 4–6 hours. Elderly or disabled patients should begin with one-third to one-half of the adult dose, with slower titration based on clinical judgement. Paediatric population: For children, dosing varies by age and indication. In general, the product is not recommended for children under 1 year unless the situation is life-saving. For children aged 1–5 years, the dose is typically 0.5 mg/kg every 4–6 hours, with a maximum daily dose of 40 mg. For those aged 6–12 years, the dose ranges from ⅓ to ½ of the adult dose, or 0.5 mg/kg every 4–6 hours, with a maximum daily dose of 75 mg. These guidelines apply across indications such as psychotic disorders and nausea/vomiting in terminal illness. Paediatric use for intractable hiccup is not recommended due to lack of data. Contra-indications: Hypersensitivity to chlorpromazine or to any of the excipients, comatose states, severe CNS depression, severe cardiovascular disease, history of blood dyscrasias including bone marrow depression and agranulocytosis, risk of angle-closure glaucoma, risk of urinary retention related to urethroprostatic disorders, dopaminergic antiparkinsonism agents, nursing mothers, citalopram and escitalopram. Special Warnings and Precautions for use: Chlorpromazine should be used during pregnancy only if clearly necessary, as animal studies have shown potential harm and human data remain limited. It may prolong labour and should be withheld until cervical dilation reaches 3–4 cm. Neonates exposed during the third trimester may experience extrapyramidal or withdrawal symptoms and should be monitored post-delivery. Use during breastfeeding is not recommended due to excretion in breast milk and potential adverse effects in the infant, including sedation and risk of tardive dyskinesia. Chlorpromazine requires careful monitoring due to risks of blood disorders, including agranulocytosis; patients should report infections or fever promptly and undergo regular blood counts. Neuroleptic malignant syndrome is a serious risk, signalled by hyperthermia and autonomic instability, and warrants immediate discontinuation. The drug is contraindicated in patients with hypothyroidism, phaeochromocytoma, myasthenia gravis, prostate hypertrophy, hypersensitivity to phenothiazines, narrow-angle glaucoma, or history of agranulocytosis. Withdrawal should be gradual to avoid symptoms like nausea, insomnia, and relapse. Chlorpromazine may prolong the QT interval, increasing the risk of fatal arrhythmias, especially in patients with bradycardia, electrolyte imbalances, or concurrent QT-prolonging medications. An ECG is recommended before starting treatment. It must be avoided in Parkinson’s disease, and caution is advised when used with lithium, dopaminergic agents, or other QT-prolonging drugs. Paralytic ileus, venous thromboembolism (VTE), and stroke are serious risks, particularly in elderly patients with dementia, who also face increased mortality. Chlorpromazine is not licensed for dementia-related.behavioural disturbances. Patients should avoid sunlight exposure due to photosensitisation risk, and handlers must prevent skin contact. Hyperglycaemia may occur, requiring monitoring in diabetic or at-risk patients. Severe liver toxicity, eosinophilia, and DRESS syndrome have been reported; any signs should prompt immediate discontinuation and investigation. Close monitoring is essential for epileptics, elderly patients, those with cardiovascular disease, hepatic or renal impairment, and those on long-term treatment (requiring regular eye and blood exams). Alcohol must be avoided. Allergic reactions may occur due to sulfite content. In children, annual assessments of cognitive function are advised, with dosage adjustments based on clinical status. Any warning from the MC, CHM CSM or MHRA: Black Triangle notice: Not applicable. A list of very common, common and serious undesirable effects Very common: weight increased, sedation, somnolence, dyskinesia (acute dystonias or dyskenisas, 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 (elderly or volume depleted subjects are particularly susceptible: it is more likely to occur after intramuscular administration), dry mouth, constipation. Common: hyperprolactinaemia, amenorrhoea, glucose tolerance impaired, anxiety, hypertonia, convulsion, ECG changes include Electrocardiogram QT prolonged (as with other neuroleptics), ST depression, and U-Wave and T-Wave changes. Serious undesirable effects include Agranulocytosis, leucopenia, thrombocytopenia, systemic lupus erythematosus, antinuclear antibody positive which may be seen without evidence of clinical disease, bronchospasm, anaphylactic reactions, erectile dysfunction, impotence, hyperglycaemia, hypertriglyceridemia, hypercholesteremia, hyponatraemia, Inappropriate antidiuretic hormone secretion, depression, torticollis, oculogyric crisis, akinesia, hyperkinesia, neuroleptic malignant syndrome (hyperthermia, rigidity, autonomic dysfunction and altered consciousness), parkinsonism in adult and elderly patients usually develops after weeks or months of treatment, ocular changes including corneal and lens opacities, cardiac arrhythmias, including ventricular arrhythmia and atrial arrhythmias, A-V block, ventricular fibrillation, ventricular tachycardia, torsades de pointes, cardiac arrest (pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose), sudden death/sudden cardiac death, embolism venous, pulmonary embolism sometimes fatal, deep vein thrombosis, respiratory depression, colitis ischaemic, ileus paralytic, intestinal perforation which is sometimes fatal, gastrointestinal necrosis and necrotising colitis which is sometimes fatal, intestinal obstruction, megacolon, jaundice cholestatic, hepatocellular liver injury, cholestatic liver injury, mixed liver injury, liver disease sometimes fatal, angioedema, urticaria, photosensitivity reaction, urinary retention, drug withdrawal syndrome neonatal, priapism, temperature regulation disorder including hypothermia, insomnia, agitation. Consult the SPC for full details of undesirable effects. Pack Size and NHS Price: 25mg/5ml 150ml – £6.00 and 100mg/5ml 150ml – £35.68 Legal category: POM. 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: 16 October 2025