TENORMIN LS

Posology The dose must always be adjusted to individual requirements of the patients, with the lowest possible starting dosage.

The following are guidelines:

Adults Hypertension One tablet daily. Most patients respond to 100 mg daily given orally as a single dose. Some patients, however, will respond to 50 mg given as a single daily dose. The effect will be fully established after one to two weeks.

A further reduction in blood pressure may be achieved by combining Tenormin with other antihypertensive agents. For example, co-administration of Tenormin with a diuretic, as in Tenoretic provides a highly effective and convenient antihypertensive therapy.

Angina Most patients with angina pectoris will respond to 100 mg given orally once daily or 50 mg given twice daily. It is unlikely that additional benefit will be gained by increasing the dose. e. 1 mg/minute). ) This may be repeated at 5 minute intervals, until a response is observed up to a maximum dosage of 10 mg.

15 mg/kg bodyweight may be administered over a 20 minute period. If required, the injection or infusion may be repeated every 12 hours. Having controlled the arrhythmias with intravenous Tenormin, a suitable oral maintenance dosage is 50–100 mg daily, given as a single dose.

Myocardial infarction For patients suitable for treatment with intravenous beta-blockade and presenting within 12 hours of the onset of chest pain, Tenormin 5–10 mg should be given by slow intravenous injection (1 mg/minute) followed by Tenormin 50 mg orally about 15 minutes later, provided no untoward effects have occurred from the intravenous dose.

This should be followed by a further 50 mg orally 12 hours after the intravenous dose, and then 12 hours later by 100 mg orally, once daily. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, Tenormin should be discontinued.

Elderly Dosage requirements may be reduced, especially in patients with impaired renal function. Paediatric population There is no paediatric experience with Tenormin and for this reason it is not recommended for use in children. Renal impairment Since Tenormin is excreted via the kidneys, the dosage should be adjusted in cases of severe impairment of renal function.

Tenormin is well tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological actions of atenolol. The following undesired events, listed by body system, have been reported with the following frequencies: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).

System Organ Class Frequency Undesirable Effect Blood and lymphatic system disorders Rare Purpura, thrombocytopenia Psychiatric disorders Uncommon Sleep disturbances of the type noted with other beta-blockers Rare Mood changes, nightmares, confusion, psychoses and hallucinations Not known Depression Nervous system disorders Rare Dizziness, headache, paraesthesia Eye disorders Rare Dry eyes, visual disturbances Cardiac disorders Common Bradycardia Rare Heart failure deterioration, precipitation of heart block Vascular disorders Common Cold extremities Rare Postural hypotension which may be associated with syncope, intermittent claudication may be increased if already present, in susceptible patients Raynaud's phenomenon Respiratory, thoracic and mediastinal disorders Rare Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints Gastrointestinal disorders Common Gastrointestinal disturbances Rare Dry mouth Hepatobiliary disorders Uncommon Elevations of transaminase levels Rare Hepatic toxicity including intrahepatic cholestasis Skin and subcutaneous tissue disorders Rare Alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes Not known Hypersensitivity reactions, including angioedema and urticaria Musculoskeletal and connective tissue disorders Not known Lupus-like syndrome Reproductive system and breast disorders Rare Impotence General disorders and administration site conditions Common Fatigue Investigations Very rare An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear Discontinuance of the drug should be considered if, according to clinical judgement, the well-being of the patient is adversely affected by any of the above reactions.

Tenormin as with other beta-blockers: • Should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7–14 days, to facilitate a reduction in beta- blocker dosage. Patients should be followed during withdrawal, especially those with ischaemic heart disease.

• When a patient is scheduled for surgery, and a decision is made to discontinue beta-blocker therapy, this should be done at least 24 hours prior to the procedure. The risk-benefit assessment of stopping beta- blockade should be made for each patient.

If treatment is continued, an anaesthetic with little negative inotropic activity should be selected to minimise the risk of myocardial depression. The patient may be protected against vagal reactions by intravenous administration of atropine.

3), may be used in patients whose signs of heart failure have been controlled. Caution must be exercised in patients whose cardiac reserve is poor. • May increase the number and duration of angina attacks in patients with Prinzmetal’s angina due to unopposed alpha-receptor mediated coronary artery vasoconstriction.

Tenormin is a beta1-selective beta- blocker; consequently, its use may be considered although utmost caution must be exercised. 3), may also aggravate less severe peripheral arterial circulatory disturbances. • Due to its negative effect on conduction time, caution must be exercised if it is given to patients with first-degree heart block.

• May mask the symptoms of hypoglycaemia, in particular, tachycardia. Beta-blockers could further increase the risk of severe hypoglycaemia when used concurrently with sulfonylureas. Diabetic patients should be advised to carefully monitor blood glucose levels.

5). • May mask the signs of thyrotoxicosis. • Will reduce heart rate as a result of its pharmacological action. In the rare instances when a treated patient develops symptoms which may be attributable to a slow heart rate and the pulse rate drops to less than 50– 55 bpm at rest, the dose should be reduced.

1 • cardiogenic shock • uncontrolled heart failure • sick sinus syndrome • second-or third-degree heart block • untreated phaeochromocytoma • metabolic acidosis • bradycardia (<45 bpm) • hypotension • severe peripheral arterial circulatory disturbances.