Propranolol Rosemont Abbreviated Prescribing Information

Abbreviated Prescribing Information: Propranolol Rosemont 5mg/5ml, 10mg/5ml, 40mg/ml, 50mg/5ml. Consult Summary of Product Characteristics before prescribing. Presentation: Oral solutions containing 5 mg, 10 mg, 40 mg, and 50 mg of propranolol hydrochloride in each 5ml respectively. Therapeutic Indications: Propranolol is indicated in the control of hypertension; the management of angina pectoris; the long term prophylaxis against reinfarction after recovery from acute myocardial infarction; control of most forms of cardiac arrhythmia; prophylaxis of migraine; management of essential tremor; relief of situational anxiety and generalised anxiety symptoms, prophylaxis of upper gastro-intestinal bleeding in patients with portal hypertension and oesophageal varices; adjunctive management of thyrotoxicosis and thyrotoxic crisis; management of hypertrophic obstructive cardiomyopathy; and management of phaeochromocytoma perioperatively (with an alpha-adrenoceptor blocking drug). Posology and Method of Administration: For oral administration only. Depending on the indication, the dose of Propranolol for Adults: Hypertension: 80 mg twice daily, increased weekly if needed. Usual range 160–320 mg/day. Angina, migraine, essential tremor: Start 40 mg two to three times daily, may be increased weekly as per response. Adequate response in migraine and essential tremor noted at 80–160 mg/day and in angina at 120–240 mg/day. Situational and generalised anxiety: Acute situational – 40 mg daily for short term relief. Generalised – 40 mg twice daily, may increase to three times daily. Review after 6–12 months. Arrhythmias, tachycardia, hypertrophic obstructive cardiomyopathy, thyrotoxicosis, anxiety: 10–40 mg three to four times daily. Post-myocardial infarction: Start between 5–21 days after myocardial infarction with 40 mg four times daily for 2–3 days. Then 80 mg twice daily. Portal hypertension: Titrate to around 25% HR reduction. Start 40 mg twice daily. Increase to 80 mg twice daily depending on heart rate response. If needed, dose may be increased incrementally to a maximum of 160 mg twice daily. Phaeochromocytoma (used only with an alpha-blocker): Pre-operative 60 mg daily for 3 days. Non-operable malignant cases 30 mg daily. Elderly: Evidence concerning the relation between blood level and age is conflicting. Treat with caution. Start with lowest dose; titrate individually according to clinical response. Paediatric population: Arrhythmias, phaeochromocytoma, thyrotoxicosis: Titrate individually according to clinical response, the following is only a guide: 250–500 micrograms/kg three to four times daily as required. Migraine: Under 12 years – 20 mg two to three times daily. Over 12 years – use adult dose. Fallot’s tetralogy: Titrate individually according to clinical response, the following is only a guide: Up to 1 mg/kg three to four times daily as required. Useful for relief of right-ventricular outflow tract shutdown, arrhythmias and angina. Contra-indications: History of bronchial asthma or bronchospasm, hypersensitivity to propranolol hydrochloride or any of the ingredients; second or third degree heart block; cardiogenic shock; metabolic acidosis; hypoglycaemia; prolonged fasting; bradycardia; hypotension; severe peripheral arterial circulatory disturbances; sick sinus syndrome; untreated phaeochromocytoma; uncontrolled heart failure or Prinzmetal’s angina. Special Warnings and Precautions for use: Caution in patients whose cardiac reserve is poor. Treatment should not be discontinued abruptly in patients with ischaemic heart disease. Should not be combined with calcium channel blockers such as verapamil or diltiazem, as severe hypotension, bradycardia or heart failure may occur, especially in patients with ventricular dysfunction or conduction abnormalities. Intravenous administration of either drug should be avoided within 48 hours of stopping the other. Propranolol may block/modify the signs and symptoms of hypoglycaemia (especially tachycardia), caution must be exercised in the concurrent use of propranolol and hypoglycaemic therapy in diabetic patients. Propranolol may aggravate less severe peripheral arterial circulatory disturbances. Should not be used in untreated phaeochromocytoma. Discontinuation of treatment for surgery should be completed at least 24 hours prior to procedure.
Dosage should be reduced where symptoms are attributable to a slow heart rate. Caution if it is given to patients with first degree heart block and when starting treatment and selecting the initial dose. Caution should be exercised in patients with impaired renal or hepatic functions, since half-life may be increased. In portal hypertension, liver function may deteriorate, and hepatic encephalopathy may develop. Propranolol may cause a more severe reaction to a variety of allergens. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions. Propranolol may mask the signs of thyrotoxicosis. Caution in decompensated cirrhosis. Propranolol should be used to treat the elderly with caution starting with a lower dose. Propranolol has been reported to interfere with the estimation of serum bilirubin by the diazo method and with the determination of catecholamines by methods using fluorescence. Should not be used in pregnancy unless essential. While there is no evidence of teratogenicity, beta-blockers may reduce placental perfusion, leading to intra-uterine death, premature or immature delivery, and adverse effects such as foetal or neonatal bradycardia and neonatal hypoglycaemia. Post-natal cardiac and pulmonary complications in the neonate have also been reported. As propranolol passes into breast milk, breastfeeding is not recommended. Any warning from the MC, CHM CSM or MHRA: Not Applicable. Black Triangle notice (if relevant): Not Applicable. A list of common and serious adverse reactions includes Common: sleep disturbances, nightmares, bradycardia, cold extremities, Raynaud’s phenomenon, fatigue and/or lassitude (often transient). Serious reactions include: thrombocytopenia, heart failure deterioration, precipitation of heart block, congestive cardiac failure, psychoses, hallucinations, memory loss, exacerbation of intermittent claudication postural hypotension which may be associated with syncope, bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints, sometimes with fatal outcome, purpura, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes, depression, isolated reports of myasthenia gravis like syndrome or exacerbation of myasthenia gravis have been reported, hypoglycaemia in neonates, infants, children, elderly patients, patients on haemodialysis, patients on concomitant antidiabetic therapy, patients with prolonged fasting and patients with chronic liver disease has been reported, seizure linked to hypoglycaemia. Bradycardia and hypotension are usually a sign of overdosage but may be rarely linked to intolerance. If this occurs the drug should be withdrawn and overdosage treatment initiated. Please refer to the SPC for full details of adverse events. Pack Size and NHS Price: 150ml – 5mg/5ml – £23.50, 10mg/5ml – £28.50, 40mg/5ml – £36.50, 50mg/5ml – £38.50. Legal Category: POM. Marketing Authorisation Number: PL 00427/0123 (10 mg/5 ml), PL 00427/0135 (40 mg/5ml), PL 00427/0124 (50 mg/5ml), and PL 00427/0122 (5 mg/5 ml). Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [Sep-2025]