Promazine Hydrochloride Abbreviated Prescribing Information

Abbreviated Prescribing Information. Consult Summary of Product Characteristics before prescribing. Promazine hydrochloride 25mg/5ml & 50mg/5ml oral syrup. Presentation. Syrups containing 25mg/5ml or 50mg/5ml Promazine Hydrochloride. Therapeutic Indications: As an adjunct to non-pharmacological interventions in the short-term management of moderate to severe agitation and restlessness where there is a risk of harm to the individual or to others. Posology and Method of Administration: For oral administration. Dosage varies based on individual and purpose. Initial dosages should be low, incremented at regular intervals. Dosage intervals are usually six to eight hours. Commencement and increase of dosage should be under close supervision. Adults: 100 mg to 200 mg, up to four times daily. Elderly: 25 mg initially, up to 50 mg four times daily. Paediatric population: Not recommended for children. Contra-indications: Hypersensitivity to promazine or other phenothiazines, coma, CNS depression, bone marrow depression, phaeochromocytoma, lactation, pregnancy. Special Warnings and Precautions for use: Acute withdrawal symptoms can occur after abrupt cessation. Caution in patients with a history of jaundice, existent liver dysfunction, blood dyscrasias, coronary insufficiency, cardiac disease, severe respiratory disease and renal failure. Prolonged use requires regular and careful monitoring of eye changes, effects on haemopoiesis, liver dysfunction, and myocardial conduction effects. Use at high doses may induce extrapyramidal side effects. Caution in patients also taking anti-parkinson agents. Prolonged administration may result in persistent or tardive dyskinesia particularly in the elderly. Therapy should be withdrawn if dyskinesia develops. Use with care in treatment of patients with cerebral arteriosclerosis, coronary heart disease or other conditions in which a fall in blood pressure might be undesirable. Caution in epilepsy or conditions predisposing to epilepsy, those with a history of narrow angle glaucoma, use in extreme weather as body temperature regulation potentially impaired, hypothyroidism, myasthenia gravis, phaeochromocytoma and prostatic hypertrophy. Promazine may increase prolactin secretion. Venous thromboembolism may occur hence preventative measures recommended in those with risk factors. There is an increased risk of cerebrovascular events in the dementia population. Mortality is also increased in elderly dementia patients and promazine is not licensed to treat dementia-related behavioural disturbances. Elderly are particularly susceptible to hypotension, sedation and temperature regulation effects. Photosensitisation may occur; avoid direct sunlight. Use with caution in patients with a history of cardiovascular disorders. Avoid concomitant use with other antipsychotics or neuroleptics. Any warning from the MC, CHM CSM or MHRA: N/A. Black Triangle notice (if relevant) N/A. The reported adverse reactions are sensitivity reactions including agranulocytosis, leucopenia, haemolytic anaemia, apathy, confusional state, effects of excitement, agitation or insomnia, withdrawal symptoms, drowsiness, dizziness, headache, sedation, epileptic fits, extrapyramidal symptoms, neuroleptic malignant syndrome, recurrence of psychotic symptoms, involuntary movement disorders, blurred vision, precipitation of glaucoma, corneal and lens opacities and purplish pigmentation of the skin, cornea, conjunctiva and retina, tachycardia, cardiovascular effects, prolongation of QT interval, T-wave changes, ventricular arrhythmias (VF, VT (rare)), sudden unexplained death, cardiac arrest and torsades de pointes, nasal stuffiness, gastrointestinal disturbances, dry mouth, constipation. Transient abnormalities of liver function tests, rarely – obstructive jaundice associated with stasis in biliary canaliculi, allergic skin reactions, rashes, contact sensitization, photosensitisation, urinary hesitancy or retention when due to enlarged prostate, menstrual disturbances, galactorrhoea, gynaecomastia, impotence, hypothermia, hyperpyrexia, unknown frequency drug withdrawal syndrome neonatal, and weight gain. Consult the Summary of Medicinal Product Characteristics (SMPC) for full details. Legal Category: POM. Pack Size and NHS Price: 25mg/5ml – 150ml, £60.19; 50mg/5ml – 150ml, £75.36. Marketing authorisation number: 25mg/5ml, PL 00427/0054; 50mg/5ml, PL 00427/5014R Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE. Date of Preparation: 03 April 2025.