BETACARDONE

Oral administration in adults:

When administering Beta-Cardone to a patient for the first time, it is desirable to start with a low dose and gradually increase the dose until the desired response is obtained; this is especially important in the elderly, as a general rule the heart rate should not be reduced to less than 55 beats per minute.

Before starting treatment or increasing the dose the corrected QT interval should be measured and renal function, electrolyte balance, and concomitant medications assessed. Treatment with sotalol should be initiated and doses increased in a facility capable of monitoring and assessing cardiac rhythm.

The dosage must be individualised and based on the patient's response. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment. Treatment with Beta-Cardone should not be discontinued suddenly, especially in patients with ischaemic heart disease (angina pectoris, prior acute myocardial infarction) or hypertension, to prevent exacerbation of the disease (see section "abrupt withdrawal" under Special Warnings).

The following are guidelines for oral administration. The initial dose is 80mg, as one or two divided doses. Oral dosage should be adjusted gradually allowing 2-3 days between dosing increments in order to attain steady-state, and to allow monitoring of QT intervals.

Most patients respond to 160 to 320mg per day, in two divided doses. The dosage should be reduced in renal impairment. : ½ recommended dose. : ¼ recommended dose.

Administration in children:

Beta-Cardone is not intended for administration to children.

The most significant adverse effects are those due to proarrhythmia, including Torsades de Pointes. There is an increased risk of Torsades de Pointes in women. Also bradycardia, dyspnoea, chest pain, palpitations, oedema, ECG abnormalities, hypotension, proarrhythmia, syncope, heart failure, presyncope.

Nausea/vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, cramps, fatigue, dizziness, asthenia, light-headedness, headache, sleep disturbances, depression, paraesthesia, mood changes, anxiety, sexual dysfunction, visual disturbances, taste abnormalities, hearing disturbances, fever, slowed AV- conduction or increase of an existing AV-block, cold and cyanotic extremities, Raynaud’s phenomenon, increase of intermittent claudication.

Beta-blockers, even those with apparent cardioselectivity should not be used in patients with asthma or a history of obstructive airways disease unless no alternative treatment is available. In such cases, the risk of inducing bronchospasm should be appreciated and appropriate precautions taken.

g. salbutamol (the dose of which may need to be greater than the usual dose in asthma) and, if necessary, intravenous atropine 1mg. There have been reports of skin rashes especially exacerbation of psoriasis and disorders of lacrimation including dry eyes and conjunctivitis.

In most cases the symptoms have cleared when the treatment was withdrawn. Discontinuance of the drug should be considered if any such reaction is not otherwise explicable. Cessation of therapy with a β-blocker should be gradual. An increase in anti-nuclear Antibodies has been seen; its clinical relevance is not clear.

Blood and lymphatic system disorders • Thrombocytopenia - frequency not known (cannot be estimated from the available data) Skin and subcutaneous tissue disorders • Alopecia - frequency not known (cannot be estimated from the available data) • Hyperhydrosis - frequency not known (cannot be estimated from the available data) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

Beta-Cardone should not be given to patients who have a history of asthma or bronchospasm. Beta-blockers may increase the sensitivity towards allergens and the seriousness of anaphylactic reactions. Patients with a history of psoriasis should take beta-blockers only after careful consideration.

Abrupt withdrawal:

Patients should be carefully monitored when discontinuing chronically administered sotalol, particularly those with ischaemic heart disease. If possible the dosage should be gradually reduced over a period of 1 to 2 weeks, if necessary at the same time initiating replacement therapy.

Hypersensitivity to catecholamines is observed in patients withdrawn from beta-blocker therapy. Occasional cases of exacerbation of angina pectoris, arrhythmias and in some cases myocardial infarction have been reported after abrupt discontinuation of therapy.

Abrupt discontinuation may unmask latent coronary insufficiency. In addition, hypertension may develop.

Proarrhythmias:

Rarely, Beta-Cardone causes aggravation of pre-existing arrhythmias or the provocation of new arrhythmias. Risk factors for Torsades de Pointes include prolongation of the QT interval, bradycardia, reduction in serum potassium and magnesium, and history of cardiomegaly or congestive heart failure, sustained ventricular tachycardia.

Proarrhythmic events can occur on initiating therapy and with every upward dose adjustment. The incidence of Torsades de Pointes is dose dependent. Caution should be used if the QTc exceeds 500 msec whilst on therapy. It is advisable to reduce dose or discontinue therapy when the QTc interval exceeds 550 msec.

Electrolyte disturbances:

Sotalol should not be used in patients with hypokalaemia or hypomagnesaemia. Potassium levels should be monitored. In conditions likely to provoke hypokalaemia/hypomagnesaemia, such as persistent diarrhoea, appropriate corrective clinical measures should be taken.

). Beta-Cardone should not be given to patients suffering from heart block or patients with Prinzmetal’s angina and those have a history of bronchospasm. In patients with poor cardiac reserve β-blockade can precipitate heart failure; in such cases, sotalol hydrochloride therapy should not be commenced until the patient has been controlled by therapy (ACE inhibitors, cardiac glycosides or, if necessary, diuretic therapy - see Interactions).

Diabetic ketoacidosis and metabolic acidosis:

Sotalol hydrochloride should not be given to patients suffering from diabetic ketoacidosis or metabolic acidosis; therapy with sotalol hydrochloride can be commenced or resumed when the metabolic condition has been corrected. Beta-Cardone should not be given to patients hypersensitive to Sotalol