Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE
BETABLOCKERS.
Because of its relative beta selectivity, however, atenolol tablet, may be used with caution in patients with bronchospastic disease who do not respond to, cannot tolerate other treatment or medically necessary. Since beta selectivity is not absolute, the lowest possible dose of atenolol tablet and a beta - stimulating agent (bronchodilator) should be made available.
If dosage must be increased, dividing the dose should be considered in order to achieve lower peak blood levels .
Normiten 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• Should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7–14 days, to facilitate a reduction in beta blocker dosage.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. Normiten 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 Atenolol is excreted via the kidneys, dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73 m2.

Although cardio selective (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, Normiten 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.

Effects on Driving

4.7 Effects on ability to drive and use machines

Atenolol 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.