TAPIFLEX

For oral administration. Atenolol oral solution is intended for patients who are unable to swallow atenolol tablets. The dose must always be adjusted to individual patient requirements with the lowest possible starting dosage. The following are guidelines.

Adults Hypertension 50 mg (two 5 ml spoonfuls) or 100 mg (four 5 ml spoonfuls) in patients unable to take 50 mg or 100 mg tablets. Most patients respond to 100 mg (four 5 ml spoonfuls) once daily. Some patients, however, will respond to 50 mg (two 5 ml spoonfuls) given as a single daily dose.

The effect will be fully established after one or two weeks. A further reduction in blood pressure may be achieved by combining atenolol with other antihypertensive agents. Angina Most patients with angina pectoris will respond to 100 mg (four 5 ml spoonfuls) given orally once a day, or 50 mg (two 5 ml spoonfuls) given twice a day.

It is unlikely that additional benefit will be gained by increasing the dose. Cardiac arrhythmias Following the initial control of the arrhythmia with atenolol injection administered by intravenous injection or infusion, a suitable oral maintenance dosage is 50 mg (two 5 ml spoonfuls) to 100 mg (four 5 ml spoonfuls) administered daily 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, atenolol should be given by slow intravenous injection in a dosage recommended by the injection manufacturer followed by 50 mg (two 5 ml spoonfuls) atenolol orally about 15 minutes later, provided no untoward effects have occurred from the intravenous dose.

This should be followed by a further 50 mg (two 5 ml spoonfuls) orally 12 hours after the intravenous dose and then 12 hours later by 100 mg (four 5 ml spoonfuls) orally, once daily. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, atenolol should be discontinued.

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

73 m2). 73 m2 (equivalent to serum creatinine of 300 – 600 micromol/litre) the oral dose should be 50 mg (two 5 ml spoonfuls) daily. 73 m2 (equivalent to serum creatinine of >600 micromol/litre) the oral dose should be 25 mg (one 5 ml spoonful) daily or 50 mg (two 5 ml spoonfuls) on alternate days.

Patients on haemodialysis should be given 50 mg (two 5 ml spoonfuls) orally after each dialysis: this should be done under hospital supervision as marked falls in blood pressure can occur.

Atenolol is well tolerated. In clinical studies, the adverse events reported are usually attributable to the pharmacological actions of atenolol. The following adverse events, listed by body system, have been reported. The following convention is used for 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) and not known (cannot be estimated from the available data).

Blood and lymphatic system disorders Rare Thrombocytopenia Psychiatric disorders Uncommon Sleep disorders of the type noted with other beta-blockers Rare Mood altered, nightmares, confusional state, psychotic disorder, hallucination Not known Depression Nervous system disorders Rare Dizziness, headache, paraesthesia Eye disorders Rare Dry eye, visual impairment Cardiac disorders Common Bradycardia Rare Heart failure deterioration, atrioventricular block Vascular disorders Common Peripheral coldness Rare Orthostatic 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 disorder Rare Dry mouth Hepato-biliary disorders Rare Hepatotoxicity including cholestasis Skin and subcutaneous tissue disorders Rare Alopecia, psoriasiform skin reactions, psoriasis, rash, purpura Not known Hypersensitivity, including angioedema and urticaria Musculoskeletal and connective tissue disorders Not Known Lupus-like syndrome Reproductive system and breast disorders Rare Erectile dysfuction General disorders and administration site conditions Common Fatigue Investigations Uncommon Transaminases increased Very rare Antinuclear antibody 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.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Atenolol, 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), it 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.

Atenolol is a beta1- selective beta-blocker: consequently, its use may be considered although utmost caution must be exercised. 3), it 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. • May mask the signs of thyrotoxicosis. • Will reduce the heart rate, as a result of its pharmacological action. In the rare instances when a treated patient develops symptoms which may be attributed to a slow heart rate and the pulse rate drops to less than 50-55 bpm at rest, the dose should be reduced.

• May cause a more severe reaction to a variety of allergens, when given to patients with a history of anaphylactic reaction to such allergens. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions.

• May cause a hypersensitivity reaction including angioedema and urticaria. 2). 73 m2. Although cardioselective (beta1) beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should be avoided in patients with reversible obstructive airways disease, unless there are compelling clinical reasons for their use.

Where such reasons exist, atenolol may be used with caution. Occasionally, some increase in airways resistance may occur in asthmatic patients, this may usually be reversed by commonly used dosage of bronchodilators such as salbutamol or isoprenaline.

The label and patient information leaflet for the product state the following warning: “If you have ever had asthma or wheezing, you should not take this medicine unless you have discussed these symptoms with the prescribing doctor”.

As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly. 32 g sorbitol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 266 mg/ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product.

This medicine contains 1 g propylene glycol in each 20 ml (four 5 ml spoonfuls) which is equivalent to 50 mg/ml. This medicine contains methyl hydroxybenzoate and propyl hydroxybenzoate which may cause allergic reaction (possibly delayed).

64% of the WHO recommended maximum daily intake of 2 g sodium for an adult This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose.

1. Atenolol, as with other beta-blockers, should not be used in patients with any of the following: • 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.