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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 short-term management of moderate to severe psychomotor agitation. Agitation and restlessness in the elderly. Posology and Method of Administration: For oral administration. Psychomotor Agitation: Adults: 100mg to 200mg, QDS. Elderly: Half the normal dose. Agitation and Restlessness: Elderly: 25mg initially, increasing, if necessary, up to 50mg, QDS. Initial doses should be low. Paediatric population: Not recommended for children. Contra-indications: Hypersensitivity to promazine or other phenothiazines, coma, CNS depression, bone marrow depression, phaeochromocytoma, lactation, and 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 Therapy should be withdrawn if dyskinesia develops.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. No. Black Triangle notice: Not applicable. Legal Category: POM. 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, 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, photosensitisation and contact sensitization, urinary hesitancy or retention when due to enlarged prostate, menstrual disturbances, galactorrhoea, gynaecomastia, impotence, hypothermia, hyperpyrexia, drug withdrawal syndrome neonatal (not known), and weight gain. 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: 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