TENORMIN Solution for injection Ref.[6738] Active ingredients: Atenolol

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• Should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7–14 days, to facilitate a reduction in beta-blocker dosage.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.
• Although contraindicated in uncontrolled heart failure (see section 4.3), 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.
• Although contraindicated in severe peripheral arterial circulatory disturbances (see section 4.3), 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.
• 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.
• 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 (epinephrine) used to treat the allergic reactions.
• May cause a hypersensitivity reaction including angioedema and urticaria.
• Should be used with caution in the elderly, starting with a lesser dose (see Section 4.2).

Since Tenormin is excreted via the kidneys, dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73 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, Tenormin may be used with caution. Occasionally, some increase in airways resistance may occur in asthmatic patients however, and this may usually be reversed by commonly used dosage of bronchodilators such as salbutamol or isoprenaline. The label and patient information leaflet for this 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.

Combined use of beta-blockers and calcium channel blockers with negative inotropic effects, e.g. verapamil and diltiazem, can lead to an exaggeration of these effects particularly in patients with impaired ventricular function and/or sinoatrial or atrioventricular conduction abnormalities. This may result in severe hypotension, bradycardia and cardiac failure. Neither the beta-blocker nor the calcium channel blocker should be administered intravenously within 48 hours of discontinuing the other.

Concomitant therapy with dihydropyridines, e.g. nifedipine, may increase the risk of hypotension, and cardiac failure may occur in patients with latent cardiac insufficiency.

Digitalis glycosides, in association with beta-blockers, may increase atrioventricular conduction time.

Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are co-administered, the beta-blocker should be withdrawn several days before discontinuing clonidine. If replacing clonidine by beta-blocker therapy, the introduction of beta-blockers should be delayed for several days after clonidine administration has stopped. (See also prescribing information for clonidine.)

Class I anti-arrhythmic drugs (e.g. disopyramide) and amiodarone may have a potentiating effect on atrial-conduction time and induce negative inotropic effect.

Concomitant use of sympathomimetic agents, e.g. adrenaline (epinephrine), may counteract the effect of beta-blockers.

Concomitant use with insulin and oral antidiabetic drugs may lead to the intensification of the blood sugar lowering effects of these drugs. Symptoms of hypoglycaemia, particularly tachycardia, may be masked (see section 4.4).

Concomitant use of prostaglandin synthetase-inhibiting drugs, e.g. ibuprofen and indometacin, may decrease the hypotensive effects of beta-blockers.

Caution must be exercised when using anaesthetic agents with Tenormin. The anaesthetist should be informed and the choice of anaesthetic should be an agent with as little negative inotropic activity as possible. Use of beta-blockers with anaesthetic drugs may result in attenuation of the reflex tachycardia and increase the risk of hypotension. Anaesthetic agents causing myocardial depression are best avoided.

Caution should be exercised when Tenormin is administered during pregnancy or to a woman who is breast-feeding.

Pregnancy

Tenormin crosses the placental barrier and appears in the cord blood. No studies have been performed on the use of Tenormin in the first trimester and the possibility of foetal injury cannot be excluded. Tenormin has been used under close supervision for the treatment of hypertension in the third trimester. Administration of Tenormin to pregnant women in the management of mild to moderate hypertension has been associated with intra-uterine growth retardation.

The use of Tenormin in women who are, or may become, pregnant requires that the anticipated benefit be weighed against the possible risks, particularly in the first and second trimesters, since beta-blockers, in general, have been associated with a decrease in placental perfusion which may result in intra-uterine deaths, immature and premature deliveries.

Breast-feeding

There is significant accumulation of Tenormin in breast milk.

Neonates born to mothers who are receiving Tenormin at parturition or breast-feeding may be at risk of hypoglycaemia and bradycardia.

Tenormin has no or negligible influence on the ability to drive and use machines. However, it should be taken into account that occasionally dizziness or fatigue may occur.

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).

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

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.

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard.

None known.