Flecainide Acetate Abbreviated Prescribing Information

Abbreviated Prescribing Information: Flecainide Acetate 50mg/5ml Oral Solution Consult Summary of Product Characteristics (SmPC) before prescribing. Presentation: A clear, colourless to straw‑coloured oral solution with a strawberry flavour, each 5ml contains 50mg flecainide acetate Therapeutic Indications: Flecainide oral solution is indicated for the treatment of AV nodal reciprocating tachycardia and arrhythmias associated with Wolff‑Parkinson‑White Syndrome or similar accessory pathway conditions when other treatment has been ineffective. It is also indicated for severe, symptomatic and life‑threatening paroxysmal ventricular arrhythmias that have not responded to or have not been tolerated with alternative therapies. Additionally, flecainide is indicated for the treatment of paroxysmal atrial arrhythmias—including atrial fibrillation, atrial flutter, and atrial tachycardia—in patients with disabling symptoms following conversion, where treatment is clearly required based on symptom severity and where other therapeutic options have been ineffective. Structural heart disease and/or impaired left ventricular function must be excluded due to increased risk of pro‑arrhythmic effects. Posology and Method of Administration: Flecainide treatment should be initiated and adjusted under medical supervision with regular ECG and plasma‑level monitoring, with hospitalisation considered for patients with life‑threatening ventricular arrhythmias. In those with underlying structural heart disease, particularly post‑myocardial infarction, therapy should only begin when other antiarrhythmics (excluding other Class IC agents) are ineffective or not tolerated and when non‑pharmacological options are unsuitable. In adults and adolescents aged 13–17 years, the recommended dose for supraventricular arrhythmias is 50 mg twice daily, increasing if necessary to a maximum of 300 mg/day, while ventricular arrhythmias require 100 mg twice daily, up to a maximum of 400 mg/day. Dose adjustment after 3–5 days should aim for the lowest effective dose, with possible reduction during long‑term therapy. In elderly patients, the initial dose should not exceed 100 mg/day and total daily dosing should remain below 300 mg. Therapeutic plasma levels generally range between 200–1000 ng/mL, with adverse cardiac effects more likely above 700–1000 ng/mL. In severe renal impairment (creatinine clearance ≤35 mL/min/1.73 m²) a maximum starting dose of 100 mg/day is advised with frequent plasma monitoring and cautious titration; dose adjustments may require 6–7 days due to markedly prolonged clearance in some patients. In hepatic impairment, dosing should not exceed 100 mg/day with close monitoring. Patients with pacemakers, or those receiving cimetidine or amiodarone, should be monitored closely and should not exceed 100 mg twice daily. Regular ECG monitoring is required monthly, with long‑term ECG every three months; during initiation or dose escalation ECGs should be performed every 2–4 days. When switching from IV to oral therapy, no dose recalculation is required due to high oral bioavailability, but an interval of 8–12 hours should be observed. Flecainide oral solution is administered orally with water and should be taken on an empty stomach or one hour before food to avoid food‑related variability Paediatric population: Use in children under 12 years is not recommended. Contra-indications: Flecainide is contraindicated in patients with hypersensitivity to the active substance or any excipients. It must not be used in individuals with cardiac failure, or in those with a history of myocardial infarction who present with asymptomatic ventricular ectopics or asymptomatic non‑sustained ventricular tachycardia. It is contraindicated in long‑standing atrial fibrillation where no attempt has been made to restore sinus rhythm, and in patients with reduced or impaired ventricular function, cardiogenic shock, severe bradycardia (<50 bpm), or severe hypotension. Flecainide must not be used in combination with Class I antiarrhythmic agents (sodium channel blockers), nor in patients with haemodynamically significant valvular heart disease. Unless pacing support is available, it must not be administered to patients with sinus node dysfunction, atrial conduction defects, second‑degree or higher atrioventricular block, bundle branch block, or distal conduction block. Flecainide is also contraindicated in patients with asymptomatic or mildly symptomatic ventricular arrhythmias, in those with significant electrolyte imbalance, and in patients with known Brugada syndrome. Special Warnings and Precautions for use: Treatment with flecainide should be undertaken under direct hospital or specialist supervision in patients with AV nodal reciprocating tachycardia, Wolff–Parkinson–White Syndrome or similar accessory‑pathway arrhythmias, and in those with paroxysmal atrial fibrillation with disabling symptoms. Flecainide increases mortality in post‑myocardial infarction patients with asymptomatic ventricular arrhythmias and, like other antiarrhythmics, may cause proarrhythmic effects including exacerbation or emergence of more severe arrhythmias. It should be avoided in patients with structural heart disease or impaired left ventricular function and used cautiously in acute postoperative atrial fibrillation. Ventricular rate acceleration in atrial fibrillation may occur if therapy fails. Flecainide prolongs the QT interval and widens the QRS complex and may unmask Brugada syndrome; treatment should be reconsidered if ECG changes suggest this. Use with caution in hepatic impairment due to reduced clearance and only if benefits outweigh risks; plasma monitoring is recommended. In renal impairment (creatinine clearance ≤35 mL/min/1.73 m²) plasma levels should be monitored closely. Dose adjustments should also consider reduced elimination in elderly patients. Electrolyte disturbances (e.g., hypo‑/hyperkalaemia) and severe bradycardia or hypotension must be corrected before treatment. Flecainide increases endocardial pacing thresholds and should be used with caution in patients with permanent or temporary pacemakers; unsuitable in patients with poor thresholds or non‑programmable devices without pacing rescue. Its mild negative inotropic effect may worsen heart failure, and defibrillation difficulty has been reported in susceptible patients. In children and infants, dairy products may reduce absorption and toxicity has been described when milk intake changes; the medicine is not approved in children under 12. Liquid formulations may cause temporary oral anaesthesia; patients should avoid eating until sensation returns. As a narrow therapeutic index drug, careful monitoring is required when switching formulations. This product contains liquid maltitol and should not be taken by patients with hereditary fructose intolerance. It contains less than 1 mmol sodium (23 mg) per 5 mL, essentially sodium‑free. Any warning from the MC, CHM CSM or MHRA: Not applicable. Black Triangle notice (if relevant) Not applicable. A list of very common, common and serious adverse reactions: Very common: dizziness, vertigo, light‑headedness, visual impairment such as diplopia and vision blurred. Common: dyspnoea, proarrhythmia, asthenia, fatigue, pyrexia, oedema, malaise. Serious: proarrhythmia, atrial flutter can develop a 1:1 AV conduction, atrioventricular block third degree, cardiac arrest, bradycardia, sinus arrest, tachycardia (AT/VT), ventricular fibrillation, cardiac failure, myocardial infarction, hypotension, palpitations, unmasking of Brugada syndrome, dose‑related increases in PR/QRS intervals, altered pacing threshold, bronchospasm, pneumonitis, pulmonary fibrosis, interstitial lung disease, syncope, convulsions, ataxia, paresthesia, tremor, somnolence, headache, neuropathy, hallucinations, confusion, depression, anxiety, amnesia, decreased RBC, WBC, platelets, increased liver enzymes with or without jaundice, hepatic dysfunction, serious urticaria, photosensitivity, urinary retention, polyuria, nausea, vomiting, abdominal pain, diarrhoea, constipation, anorexia, dyspepsia, antinuclear antibody increases. Consult the SmPC for full details of adverse events. Pack Size and NHS Price: 150ml – £300.00. Marketing Authorisation Number: PL 00427/0310. Legal Category: POM. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: [January-2026]