Cardirest Tablets

Treatment with Cardirest should be initiated in a hospital for control of the following dysrhythmias:

• Sustained ventricular dysrhythmias.
• AV nodal reciprocating tachycardia; Wolff - Parkinson - White Syndrome and similar conditions with accessory pathway and anterograde or retrograde conduction.
• Paroxysmal atrial fibrillation in patients with disabling symptoms. Dysrhythmias of recent onset are more likely to respond.
• In addition, Cardirest tablets are indicated in premature ventricular contractions and/or non - sustained ventricular tachycardia if these are causing disabling symptoms.
• Cardirest tablets can be used for the maintenance of normal rhythm following conversion by other means.

Contraindications

Cardirest is contraindicated in:

• Hypersensitivity to flecainide or any excipients of Cardirest see section 6.1.
• Patients with cardiac failure, and in patients with a recent myocardial infarction or a history of myocardial infarction who have either asymptomatic ventricular ectopics or asymptomatic non - sustained ventricular tachycardia.
• Pregnancy and lactation (see section 4.6).
• Patients with long standing atrial fibrillation and in patients with haemodynamically significant valvular heart disease. Unless pacing rescue is available, Cardirest should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrio - ventricular block, bundle branch block or distal block.
• Cardirest is also contra - indicated in the presence of cardiogenic shock.

Special warnings and precautions for use

Increased mortality risk Cardirest has been shown to increase mortality risk of post - myocardial infarction patients with asymptomatic ventricular dysrhythmia. In post - myocardial infarction patients with asymptomatic ventricular dysrhythmia, oral flecainide was associated with a 2.2 fold higher incidence of mortality or non - fatal cardiac arrest as compared with its matching placebo. An even higher incidence of mortality was observed in flecainide - treated patients with more than one myocardial infarction. There is no evidence that the use of Cardirest favourably affects survival or the incidence of sudden death.

Oral use.

Posology

Supra - ventricular dysrhythmias: The recommended starting dosage is 50 mg twice daily and most patients will be controlled at this dose. If required, the dose may be increased to a maximum of 300 mg daily.

Ventricular dysrhythmias: The recommended starting dosage is 100 mg twice daily. The maximum daily dose is 400 mg daily and this is normally reserved for patients of large build or where rapid control of the dysrhythmia is required. After 3 – 5 days it is recommended that the dosage be progressively adjusted to the lowest level which maintains control of the dysrhythmia. It may be possible to reduce the dosage during long - term treatment.

Undesirable effects

System organ class Frequency Blood and lymphatic system disorders Less frequent Decreased red blood cell count, white blood cell count and platelet count. Immune system disorders Less frequent Antinuclear antibody increased with and without systemic inflammation. Psychiatric disorders Less frequent Hallucination, depression, confusion, anxiety, amnesia and insomnia. Nervous system disorders Frequent Giddiness, dizziness and light - headedness. Less frequent Paraesthesia, ataxia, hypoaesthesia, hyperhidrosis, syncope, tremor, flushing, somnolence, headache, neuropathy peripheral, convulsion and dyskinesia. Eye disorders Frequent Visual disturbances, such as diplopia and blurred vision. Less frequent Corneal deposits. Ear and labyrinth disorders Less frequent Tinnitus, vertigo. Cardiac disorders Frequent Pro - dysrhythmic effects, occurs more frequently in patients with structural heart disease and/or significant left ventricular impairment (see section 4.4) a. Less frequent Patients with atrial flutter can develop a 1:1 AV conduction with increased heart rate. Frequency unknown Dose - related increases in PR and QRS intervals may occur (see section 4.4). Altered pacing threshold (see section 4.4). Atrioventricular block second degree and atrioventricular block third degree, cardiac arrest, bradycardia, cardiac failure/cardiac failure congestive, chest pain, hypotension, myocardial infarction, palpitations, sinus pause or arrest, and tachycardia (AT or VT) or ventricular fibrillation. Demasking of a pre - existing Brugada syndrome. Respiratory, thoracic and mediastinal disorders Frequent Dyspnoea. Less frequent Pulmonary fibrosis, interstitial lung disease, pneumonitis. Gastrointestinal disorders Less frequent Nausea, vomiting, constipation, abdominal pain, decreased appetite, diarrhoea, dyspepsia, flatulence. Hepatobiliary disorders Less frequent Elevated hepatic enzymes with or without jaundice. Frequency unknown Hepatic dysfunction. Skin and subcutaneous tissue disorders Less frequent Allergic dermatitis, including rash, alopecia, serious urticaria.

Special precautions for storage

Store at or below 30 °C.