Atenolol 25mg Tablets – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Atenolol 25mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Atenolol 25mg

For excipients, see 6.1.

3 PHARMACEUTICAL FORM

White, circular, biconvex, uncoated tablets with ‘FIL’ engraved above the score line, ‘25’ below the score line, on one side and plain on the other side.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Atenolol 25mg tablets are indicated for the management of:

Hypertension

Angina pectoris

Cardiac arrhythmias

Acute myocardial infarction, as early intervention.

4.2 Posology and method of administration

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:

The majority of patients respond to a single oral dose of 100mg daily though some patients respond to 50mg, the effect being established fully after one or two weeks. A further reduction in blood pressure may be obtained by combining atenolol tablets with other antihypertensive therapy such as diuretics. For example, co-administration of atenolol with a diuretic, as in atenolol provides a highly effective and convenient antihypertensive therapy.

Angina:

The majority of patients respond to a single oral dose of 100mg daily or to 50mg given twice daily. Increasing the dose above l00mg daily is unlikely to confer additional benefit.

Cardiac arrhythmias.

A suitable initial dose of atenolol is 2.5 mg (5 ml) injected intravenously over a 2.5 minute period (i.e. 1 mg/minute). (See also prescribing information for atenolol Injection.) This may be repeated at 5 minute intervals, until a response is observed up to a maximum dosage of 10 mg. If atenolol is given by infusion, 0.15 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 atenolol, 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, atenolol 5–10 mg should be given by slow intravenous injection (1 mg/minute) followed by atenolol 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, atenolol should be discontinued.

Method of administration

For oral administration only.

Use in Children

Not

recommended.

Use in the

Elderly

Elderly patients may require a lower dose, especially those with impaired renal function.

Renal Failure

Since atenolol is excreted via the kidneys, the dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs in patients who have a creatinine clearance greater than 35 ml/min/1.73 m² (normal range is 100–150 ml/min/1.73 m²).

For patients with a creatinine clearance of 15–35 ml/min/1.73 m² (equivalent to serum creatinine of 300–600 micromol/litre), the oral dose should be 50 mg daily and the intravenous dose should be 10 mg once every two days.

For patients with a creatinine clearance of less than 15 ml/min/1.73 m² (equivalent to serum creatinine of greater than 600 micromol/litre), the oral dose should be 25 mg daily or 50 mg on alternate days and the intravenous dose should be 10 mg once every four days.

Patients on haemodialysis should be given 50 mg orally after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

4.3 Contraindications

Atenolol tablets must not be given to patients with a known hypersensitivity to atenolol or any of the excipients. Beta-blocking drugs including atenolol tablets should not be given to patients with bradycardia (<45 bpm), cardiogenic shock, hypotension, second or third degree heart block, sick sinus syndrome, uncontrolled heart failure, severe peripheral arterial circulatory disturbances, untreated phaeochromocytoma or metabolic acidosis.

4.4 Special warnings and precautions for use

Like other beta-blockers: atenolol tablets may be used in patients whose heart failure is controlled but should be used with caution in those 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 beta1selective 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.
• Atenolol tablets have a negative effect on conduction time and caution must be used if given to patients with first degree heart block.
• Atenolol 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.

May mask the symptoms of hypoglycaemia, and thyrotoxicosis, 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. (see Section 4.5).

• 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.
• 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 35ml/min/1.73m².
• 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
• Though cardioselective, atenolol tablets should not be given to patients with reversible obstructive airways disease, unless there are compelling clinical reasons for its use when it should be used with caution. Airways resistance may occasionally increase in some asthmatic patients but is usually responsive to treatment with normal doses of bronchodilators.
• May cause a hypersensitivity reaction including angioedema and urticaria.
• 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.

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 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.

Contains Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of atenolol with antihypertensive agents as well as with other drugs with blood pressure lowering potential (e.g. tricyclic antidepressants, barbiturates,phenothiazines) may increase the risk of hypotension.

Combined use with dihydropyridine calcium antagonists, such as nifedipine, may precipitate hypotension and cardiac failure. Enhanced hypotensive effects are observed, when beta blockers given with alpha-blockers, also increased risk of first-dose hypotension with post- synaptic alpha-blockers such as prazosin.

Possible severe postural hypotension when beta-blockers given with moxisylyte.

Prostaglandin synthetase inhibitors, such as ibuprofen or indomethacin, oestrogens and corticosteroids given with atenolol tablets may reduce its hypotensive effect.

Atenolol tablets may exacerbate the rebound hypertension which may follow clonidine withdrawal so, if given together, atenolol tablets should be stopped several days before clonidine. If used in place of clonidine, atenolol tablets should not be started until several days after stopping clonidine.

Concomitant use of atenolol with sympathicomimetic agents such as adrenaline, dobutamine etc. may counteract its effects.

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

Class - III antiarrhythmic drugs (e.g. amiodarone): Effect on atrial conduction time may be potentiated.

Combined use with calcium channel blockers with a negative inotropic effect, such as verapamil and diltiazem, may exaggerate this effect especially in patients with impaired ventricular function and sino-atrial or atrio-ventricular conduction abnormalities, leading to bradycardia, severe hypotension and cardiac failure. Neither the beta-blocker nor the calcium antagonist should be given intravenously within 48 hours of stopping the other.

Digitalis glycosides given with atenolol tablets may increase atrio-ventricular conduction time.

Concomitant use with insulin and oral antidiabetic drugs may lead to the intensification of the blood sugar lowering effects of these drugs. The concomitant use of beta-blockers with sulfonylureas could increase the risk of severe hypoglycaemia. Symptoms of hypoglycaemia, particularly tachycardia, may be masked (see section 4.4).

Increased peripheral vasoconstriction when beta-blockers given with ergotamine, and methysergide.

The anaesthetist must be informed that the patient is on atenolol tablets if an anaesthetic is to be given and the anaesthetic with least negative inotropic action should be chosen. Care must be used when giving anaesthetics with atenolol tablets as the combination may attenuate the reflex tachycardia and increase the risk of hypotension. Anaesthetics causing myocardial depression should be avoided, if possible.

4.6 Fertility, Pregnancy and lactation

Pregnancy:

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

The use of atenolol 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 growth retardation, intra-uterine deaths, abortion, immature and premature deliveries

Lactation:

Atenolol accumulates to a significant extent in breast milk so it should only be used with caution in women who are breast feeding.

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

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

4.7 Effects on ability to drive and use machines

Atenolol tablets are unlikely to impair patients ability to drive or operate machinery unless fatigue or dizziness occur, about which the patient should be warned.

4.8 Undesirable effects

Atenolol tablets are well tolerated and the adverse effects experienced are usually a result of its pharmacological action.

The following undesired events, listed by body system, have been reported with the following frequencies: very common (10%), common (1–9.9%), uncommon (0.1–0.9%), rare (0.01–0.09%), very rare (<0.01%) 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 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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Overdosage may be indicated by bradycardia, hypotension, acute heart failure and bronchospasm. Treatment should be supportive, carried out in an intensive care unit, and include gastric lavage, activated charcoal and a laxative to reduce absorption of any drug remaining in the gut and to encourage sink conditions for back diffusion. Hypotension and shock may require treatment with plasma or plasma substitutes. Haemoperfusion and haemodialysis should be considered.

Bronchospasm is usually reversed by giving bronchodilators. Bradycardia may be treated with 1 - 2mg intravenous atropine or a pacemaker and followed, if necessary, by an intravenous bolus of 10mg glucagon repeated as required or followed by an intravenous infusion of glucagon 1 - 10mg/hr depending on the response. If there is no response to glucagon or if it is unavailable, a beta stimulant should be given by intravenous infusion, such as dobutamine 2.5 to l0 µg/kg/minute. Dobutamine may also be used to treat hypotension and acute heart failure because of its positive inotropic effect. If a large overdose has been taken, it is unlikely that these doses of dobutamine would be sufficient to reverse the cardiac effects of beta-blockade and they should be increased according to the response of the patient in order to achieve the desired clinical condition.

5.1 Pharmacodynamic properties

Atenolol is a hydrophilic beta₁-selective adrenoreceptor blocking drug, that is, it acts preferentially on beta₁ -adrenoreceptors in the heart, but selectivity decreases with increasing dose. It does not have intrinsic sympathomimetic activity or membrane stabilising activity. Like other beta-adrenoceptor blocking drugs, its antihypertensive mode of action is unclear and it is negatively inotropic and so is contra-indicated in uncontrolled heart failure. Its reduction of heart rate and myocardial contractility is probably responsible for its anti-anginal activity. It is unlikely that the S- form has any therapeutic effects not possessed by the racemic mixture.

Clinical efficacy and safety

Atenolol is effective and well tolerated in most ethnic populations although the response may be less in black patients. Atenolol is effective for at least 24 hours after a single oral dose. The drug facilitates compliance by its acceptability to patients and simplicity of dosing. The narrow dose range and early patient response ensure that the effect of the drug in individual patients is quickly demonstrated. Atenolol is compatible with diuretics, other hypotensive agents and antianginals (see Warnings and Interactions). Since it acts preferentially on beta-receptors in the heart, atenolol may, with care, be used successfully in the treatment of patients with respiratory disease, who cannot tolerate non-selective beta blockers.

Early intervention with atenolol in acute myocardial infarction reduces infarct size and decreases morbidity and mortality. Fewer patients with a threatened infarction progress to frank infarction; the incidence of ventricular arrhythmias is decreased and marked pain relief may result in reduced need of opiate analgesics. Early mortality is decreased. Atenolol is an additional treatment to standard coronary care.

5.2 Pharmacokinetic properties

When given by mouth, absorption of atenolol is consistent but incomplete with only about 40-50% being absorbed. Hepatic metabolism is insignificant and more than 90% reaches the systemic circulation. Plasma concentrations peak 24 hours after dosing, are consistent and subject to little variation. The plasma elimination half life is about 6 hours but this is increased in severe renal failure as the kidney is the main route of elimination. Plasma protein binding is about 3%.

Atenolol penetrates tissues poorly and brain tissue levels are low due to its low lipid solubility.

5.3 Preclinical safety data

Oral atenolol is well tolerated in animals. Oral daily doses of 5 mg/kg in rats and 15 mg/kg in dogs were tolerated in long term toxicity studies without evidence of significant changes. Doses of 200 mg/kg in rats and 300 mg/kg in dogs were associated with an increase in heart and spleen weight. In animal tests atenolol has shown no mutagenic, carcinogenic or teratogenic potential and does not impair fertility.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Microcrystalline cellulose

Sodium starch glycollate

Maize starch

Magnesium stearate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

30 months

6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package.

6.5 Nature and contents of container

Blister strip comprising aluminium foil on one side and PVC on the other. The strips are packed in cartons to contain 28 or 50 tablets.

6.6 Special precautions for disposal

None

7 MARKETING AUTHORISATION HOLDER

Special Concept Development (UK) Limited t/a Rx farma, Units 1-7, Colonial Way, Watford,

Hertfordshire, WD24 4YR.

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 36722/0046

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

07/09/2026

10 DATE OF REVISION OF THE TEXT

07/09/2026