VISKEN

Posology Adults Essential Hypertension:

Initially one 5 mg tablet two or three times a day. According to the response of the patient the dose may be increased at weekly intervals to a maximum of 45 mg given in divided doses twice or three times daily.

Once daily dosage schedule:

Further work shows that many patients respond to a once daily dosage regime. Initially 15 mg (3 tablets) should be taken once a day with breakfast and adjusted according to individual response up to a maximum of 45 mg (9 tablets). Most patients respond to a once daily dose of between 15-30 mg (3-6 tablets).

The onset of action of this medicine is usually rapid, with most patients showing a response within the first one to two weeks of treatment. However, the maximum response may take several weeks to develop. 5 mg to 5 mg orally three times a day according to response.

It reduces the frequency and severity of anginal attacks and increases work capacity. Elderly No evidence exists that elderly patients require different dosages or show different side-effects from younger patients. Paediatric population The safety and efficacy of this medicine in children has not been established.

Its use is therefore not recommended. Method of administration Oral.

The following undesirable effects have been observed and reported during treatment with Pindolol with the following frequency: Not known – cannot be estimated from the available data. System organ class Undesirable effects Blood and lymphatic system disorders Thrombocytopenia (sometimes with purpura), agranulocytosis Metabolism and nutrition disorders Diabetes mellitus, hypoglycaemia, hyperglycaemia Psychiatric disorders Hallucination, acute psychosis, sleep disorder, depression, nightmare, confusional state, libido disorder Nervous system disorders Headache, dizziness, tremor Eye disorders Visual impairment, vision blurred, vision abnormal, keratoconjunctivitis, dry eyes Cardiac disorders Bradycardia, complete atrioventricular block, cardiac failure, cardiac arrhythmia Vascular disorders Hypotension, peripheral coldness, Raynaud’s phenomenon, paraesthesia, intermittent claudication, necrotising vasculitis Respiratory, thoracic and mediastinal disorders Bronchospasm (in patients with bronchial asthma or a history of bronchial complaints), dyspnoea Gastrointestinal disorders Diarrhoea, nausea, vomiting, constipation, dry mouth, sclerosing peritonitis, retroperitoneal fibrosis, abdominal discomfort, dyspepsia, flatulence Musculoskeletal and connective tissue disorders Muscle spasms, arthralgia, myalgia, myasthenia gravis Skin and subcutaneous tissue disorders Rash, psoriasis, toxic epidermal necrolysis, cutaneous lupus erythematosus, pruritus, hyperhidrosis Reproductive system and breast disorders Erectile dysfunction Renal and urinary disorders Glycosuria General disorders and administration site conditions Fatigue, hyperpyrexia Investigations Increased antinuclear antibodies Chronic treatment with pindolol increases very low density lipoprotein and decreases high density lipoprotein, which may have an adverse effect on the risk of cardiovascular events.

Beta-blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Patients with a poor cardiac reserve should be stabilised with digitalis before treatment with Visken/ Pindolol Tablets to prevent impairment of myocardial contractility. As for other beta-blockers, and especially in patients with ischaemic heart disease, treatment should not be discontinued suddenly.

e. over 1-2 weeks, if necessary at the same time initiating replacement therapy, to prevent exacerbation of angina pectoris. As beta-blockers increase the AV conduction time, beta-blockers should only be given with caution to patients with first degree AV block.

If the patient develops increasing bradycardia less than 50-55 beats per minute at rest and the patient experiences symptoms related to bradycardia, the dosage should be reduced or gradually withdrawn. As with all antihypertensive agents, a cautious dosage schedule is indicated in patients with severe coronary or cerebral arteriosclerosis.

As with all beta-blockers, Visken/ Pindolol Tablets should be used with caution in patients with a history of a recent myocardial infarction. Caution must be exercised when beta-blocking agents are administered to patients with spontaneous hypoglycaemia or diabetes under treatment with insulin or oral hypoglycaemic agents, since hypoglycaemia may occur during prolonged fasting and some of its symptoms (tachycardia, tremor) may be masked.

Beta-blockers may also mask the symptoms of thyrotoxicosis. Beta-blockers may unmask myasthenia gravis. g. halothane, cyclopropane, trichloroethylene, ether, chloroform). Visken/ Pindolol Tablets should be gradually withdrawn before elective surgery.

In emergency surgery or cases where withdrawal of Visken/ Pindolol Tablets would cause deterioration in cardiac condition, atropine sulphate 1 to 2 mg intravenously should be given to prevent severe bradycardia. If a beta-blocker is indicated in a patient with phaeochromocytoma it must always be given in conjunction with an alpha-blocker.

1. • Untreated cardiac failure • Cardiogenic shock • Sick sinus syndrome • Sino-atrial block • Second and third degree heart block • Prinzmetals angina • History of bronchospasm and bronchial asthma (a warning stating "do not take this medicine if you have a history of wheezing or asthma" will appear on the label) • Untreated phaeochromocytoma • Peripheral circulatory disease • Pronounced bradycardia • Hypotension • Chronic obstructive pulmonary disease • History of cor pulmonale • Metabolic acidosis • Prolonged fasting • Severe renal failure • Use of anaesthetics with a negative inotropic effect Owing to the danger of cardiac arrest, a calcium antagonist of the verapamil type must not be administered intravenously to the patient already receiving treatment with a beta-blocker.