VELORIN Film-coated tablet Ref.[28201] Active ingredients: Atenolol

Velorin, as with other beta-adrenoceptor blocking agents:

• 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. Velorin is a beta1-selective beta-adrenoceptor blocking drug; 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 may be reduced.
• should not be discontinued 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 The dosage should be withdrawn gradually over a period of 7–14 days, to facilitate a reduction in beta-blocker dosage.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.
• 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.
• 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.
• may cause an increase in airways resistance in asthmatic patients. Velorin is a beta1-selective beta-blocker; consequently its use may be considered although utmost caution must be exercised. If increased airways resistance does occur, Velorin should be discontinued and bronchodilator therapy (e.g. salbutamol) administered if necessary.
• should only be given to patients with psoriasis after careful consideration, as psoriasis may be aggravated.

Since Velorin is excreted via the kidneys, dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73 m².

As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly.

Adrenergic neurone-blocking agents

Adrenergic neurone-blocking agents such as guanethidine, reserpine, diuretics and antihypertensive agents, including the vasodilator group, will have an additive effect on the hypotensive action of the drug.

Anaesthetic agents

Caution must be exercised when using anaesthetic agents with Velorin. 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.

Antiarrhythmic agents (Class 1)

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

Calcium channel blockers

Combined use of beta-blockers and calcium channel blockers with negative inotropic effects, e.g. verapamil or 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.

Clonidine

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).

Digitalis glycosides

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

Dihydropyridines

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

Insulin and oral antidiabetic drugs

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).

Myocardial depressants

The beta-blocker should only be used with caution in patients who are receiving concomitant myocardial depressants such as halogenated anaesthetics, lidocaine, procainamide and beta-adrenoceptor stimulants such as noradrenaline (norepinephrine).

Prostaglandin synthetase-inhibiting drugs

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

Sympathomimetic agents

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

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

Pregnancy

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

The use of Velorin 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.

Breast-feeding

There is significant accumulation of Velorin in breast milk.

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

Velorin 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.

Velorin is well tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological actions of atenolol.

Tabulated list of adverse reactions

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).

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 continue. Monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.

Not applicable.