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Atenolol Abbreviated Prescribing Information

Abbreviated Prescribing Information: Tapiflex 25 mg/5 ml oral solution and Atenolol 25 mg/5 ml Sugar Free Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: Clear colourless oral solution with an odour of lemon and lime. Each 5 ml contains 25 mg atenolol. Therapeutic Indications: Atenolol oral solution is indicated for management of hypertension, angina, cardiac arrhythmias, and myocardial infarction-early intervention in the acute phase. Posology and Method of Administration: For oral administration. Atenolol oral solution is intended for patients who are unable to swallow atenolol tablets and dose must always be adjusted to individual patient requirements with the lowest possible starting dosage. In adult patients with hypertension, the dose is 50 mg (two 5 ml spoonful’s) or 100 mg (four 5 ml spoonful’s). Most patients with angina pectoris will respond to 100 mg (four 5 ml spoonful’s) given orally once a day, or 50 mg (two 5 ml spoonful’s) given twice a day. In patient with cardiac arrhythmias, 50 mg (two 5 ml spoonful’s) to 100 mg (four 5 ml spoonful’s) administered daily as a single dose following initial intravenous injection or infusion of atenolol. For patients with Myocardial infarction, 15 minutes after the initial atenolol intravenous injection, 50 mg (two 5 ml spoonful’s) to be administered, provided no untoward effects have occurred from the intravenous dose. This should be followed by a further 50 mg (two 5 ml spoonful’s) orally 12 hours after the intravenous dose and then 12 hours later by 100 mg (four 5 ml spoonful’s) orally, once daily. Atenolol should be used with caution in the elderly, especially in patients with impaired renal function. For patients with impaired renal function, the daily oral dose should be 50 mg (two 5 ml spoonful’s) when creatinine clearance is 15-35 ml/min/1.73m2 and 25 mg (one 5 ml spoonful) daily or 50 mg (two 5 ml spoonful’s) on alternate days when creatinine clearance is <15 ml/min/1.73m2. Patients on haemodialysis should be given 50 mg (two 5 ml spoonful’s) orally after each dialysis and this should be done under hospital supervision as marked falls in blood pressure can occur. Paediatric population: Atenolol oral solution is not recommended for use in children. Contra-indications: Atenolol oral solution is contraindicated in patients with hypersensitivity to atenolol or to any of the excipients; cardiogenic shock, uncontrolled heart failure, sick sinus syndrome, second- or third-degree heart block, untreated phaeochromocytoma, metabolic acidosis, bradycardia (<45 bpm), hypotension, and severe peripheral arterial circulatory disturbances. Special Warnings and Precautions for use: Atenolol, as with other beta-blockers should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7-14 days. Patients should be monitored closely during withdrawal, especially those with ischaemic heart disease. Caution should be exercised with the following: when a patient is scheduled for surgery, in patients with poor cardiac reserve, usage of drug in patients with Prinzmetal’s angina, usage of drug in less severe peripheral arterial circulatory disturbances, patients with first degree heart block. Atenolol may mask the symptoms of hypoglycaemia, in particular tachycardia and thyrotoxicosis. Atenolol should be used with caution in elderly patients, starting with the lowest possible starting dosage. Dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73 m2, and in patients with reversible obstructive airways disease. Furthermore, atenolol may cause hypersensitivity reactions including angioedema and urticaria. Atenolol may reduce the heart rate, because of its pharmacological action and may cause a more severe reaction to a variety of allergens, when given to patients with a history of anaphylactic reaction. In patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. Additionally, atenolol may cause allergic reactions (possibly delayed) as this medicine contains methyl hydroxybenzoate and propyl hydroxybenzoate. Any warning from the MC, CHM CSM or MHRA: No. Black Triangle notice: not applicable. Undesirable Effects: A list of common and serious adverse reactions are presented here: Common: Bradycardia, peripheral coldness, gastrointestinal disorder and fatigue. Serious adverse reactions: Thrombocytopenia, sleep disorders, nightmares, confusional state, psychotic disorder, hallucination, depression, paraesthesia, visual impairment, heart failure deterioration, atrioventricular block, orthostatic hypotension, syncope, intermittent claudication, Raynaud’s phenomenon, bronchospasm, hepatotoxicity, cholestasis, psoriasiform skin reactions, psoriasis, hypersensitivity, angioedema, lupus-like syndrome, erectile dysfunction and antinuclear antibody. Refer to the SmPC for full details of adverse reactions. Legal Category: Prescription only medicine. Pack Size and NHS Price: 300ml – £10.48. Marketing Authorisation Number: PL 00427/0280. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [November-2025]

 

Adverse Events

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk
Adverse events should also be reported to Rosemont at 0113 244 1400 or pharmacovigilance@rosemontpharma.com.