Atenolol tablets BP 50 mg – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Atenolol 50mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 50 mg of Atenolol

Excipient with known effect: The tablet contains Sunset yellow aluminium lake (E110)

For the full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Film-coated Tablets

Orange, film-coated normal convex tablet, debossed with 50 on one face and plain on the other face.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Management of hypertension

Management of angina pectoris

Management of cardiac dysrhythmias

Myocardial infarction - early intervention in the acute phase

4.2 Posology and method of administration

Posology

Hypertension

The usual dose is one 100 mg tablet daily. Some patients may respond to a dose of one 50 mg tablet daily. The therapeutic effect is fully established after administration for one to two weeks. Further reduction in blood pressure, if desired, can be achieved by combining atenolol with other antihypertensive agents.

Angina pectoris

One 100 mg tablet once daily or one 50 mg tablet twice daily are taken. Additional benefit is unlikely to be gained by increasing the dose.

Cardiac dysrhythmias

Having controlled the dysrhythmia with intravenous atenolol the maintenance oral dose is one 50mg tablet to one 100 mg tablet daily as a single dose.

Myocardial infarction

Patients presenting within 12 hours of the onset of chest pains and suitable for beta blockade therapy:

5 to 10 mg of atenolol is administered by slow intravenous injection (1 mg/minute). If no adverse effects occur following the intravenous dose, then 15 minutes later one 50 mg tablet is administered orally followed by a further 50 mg tablet, 12 hours after the intravenous dose. Then 12 hours later one 100 mg tablet is given orally, once daily. If bradycardia and/or hypertension requiring treatment, or any other side effects, occur atenolol therapy should be discontinued.

Elderly patients

Dosage requirements may be reduced, especially in those with impaired renal function.

Paediatric population

Atenolol is not recommended for use in children as there is no paediatric experience with atenolol.

Renal impairment

Since atenolol is excreted via the kidneys dosage should be adjusted in cases of severe impairment of renal function. No significant accumulation of atenolol occurs at a GFR greater than 35 ml/min/1.73m2 (normal range is 100-150 ml/min/1.73m2).

For patients with a creatinine clearance of 15-35 ml/min/1.73m2 (equivalent to serum creatinine of 300-600 µmol/litre) the oral dose should be one 50 mg tablet daily or one 100 mg tablet once every two days; the intravenous dose should be 10 mg once every two days. For patients with a creatinine clearance of <15 ml/min/1.73m2 (equivalent to serum creatinine of <600 µmol/litre) the oral dose should be one 50 mg tablet on alternate days or one 100 mg tablet once every four days; 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.

Method of administration

For administration by the oral route

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section

  6.1.

• Severe bradycardia
• Second degree or third degree heart block
• Uncontrolled heart failure
• Prinzmetal’s angina hypotension
• Severe peripheral arterial circulatory disturbances (including intermittent claudication)
• Sick sinus syndrome
• Cardiogenic shock.
• Hypotension
• Phaeochromocytoma (without a concomitant alpha blocker).
• Metabolic acidosis.

Although cardioselective 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 asthma or a history of reversible obstructive airways disease or bronchospasm (see Section 4.4), unless there are compelling clinical reasons for their use.

4.4 Special warnings and precautions for use

• Care should be taken when using beta-blockers in patients with poor cardiac reserve. Myocardial contractility must be maintained and signs of failure controlled with digitalis and diuretics.

Therapy should not be withdrawn abruptly, especially in patients with ischaemic heart disease, and replacement therapy should be considered to prevent exacerbation of angina pectoris, rebound hypertension, myocardial infarction, ventricular arrhythmias and sudden cardiac death (see section 4.8). Treatment should not be discontinued abruptly in patients on long-term therapy, but should be discontinued over one to two weeks.

• If a beta-blocker is withdrawn prior to surgery it should be discontinued for at least 24 to 48 hours, if the patient is being anaesthetised. If beta blockers are not discontinued before anaesthesia, the anaesthetist should be made aware of the beta-blocker therapy. A drug such as atropine may be given to counter increases in vagal tone. Anaesthetics causing myocardial depression such as ether, cyclopropane, trichloroethane, halothane and enflurane should be avoided (see section 4.5).
• Atenolol reduces heart rate. In instances when symptoms may be attributable to the slow heart rate, the dose should be reduced. Beta-blockers should be used with caution in first degree AV block and portal hypertension (risk of deterioration in liver function).
• Beta-blockers may increase both the sensitivity towards allergens and seriousness of anaphylactic reactions. Patients with a history of anaphylaxis to an antigen may be more reactive to repeated challenge with the antigen while taking beta blockers. Beta blockers may also reduce the response to adrenaline. They may unmask myasthenia gravis or potentiate a myasthenic condition.
• Patients with psoriasis should only be given beta-blockers after careful consideration, as psoriasis may be aggravated.
• Atenolol should be used with caution in diabetics subject to frequent episodes of hypoglycaemia. The risk of hyperglycaemia is increased with concomitant use of a beta blocker and a thiazide. Symptoms of hypoglycaemia and of hyperthyroidism may be masked (see section 4.5).
• The product label will carry the warning "Do not take this medicine if there is a history of wheezing or asthma."
• If the use of atenolol in patients with asthma or a history of obstructive airways disease is unavoidable, the risk of inducing bronchospasm should be appreciated and administration of atenolol should be initiated with extreme caution and under specialist supervision. If bronchospasm occurs, this will usually be reversed by commonly used bronchodilators such as salbutamol or isoprenaline.
• In patients with renal impairment or hepatic dysfunction, atenolol should be used with caution and reduction of dosage should be considered (see section 4.2).
• As with other beta-blockers, in patients with a phaeochromocytoma, an alpha- blocker should be given concomitantly.

4.5 Interaction with other medicinal products and other forms of interaction

Alcohol: Enhanced hypotensive effect

Aldesleukin: Enhanced hypotensive effect.

Alprostadil: Enhanced hypotensive effect.

Ampicillin: Reduces atenolol serum levels.

Anaesthetics: Enhanced hypotensive effect. Avoid anaesthetics which cause myocardial depression, e.g. ether, cyclopropane, trichloroethylene, halothane and enflurane (see section 4.4).

Analgesics: Antihypertensive effects of beta-blockers may be impaired by non-steroidal anti-inflammatory drugs (NSAIDs), particularly ibuprofen and indomethacin.

Antacids: Reduced absorption of atenolol may occur if antacids containing calcium or aluminium and magnesium are administered concomitantly.

Antiarrhythmics and other drugs affecting cardiac conduction: (e.g. disopyramide amiodarone, quinidine) additive negative inotropic effects on the heart, with increased risk of bradycardia, hypotension, ventricular fibrillation, heart block or asystole - avoid concomitant use.

Anticholinesterase agents: Increased risk of bradycardia

Antidepressants and antipsychotics: Phenothiazines and tropisetron may increase the risk of ventricular arrhythmias. Enhanced hypotensive effect with monoamine oxidase inhibitors (MAOIs).

Antidiabetics: Dosage of hypoglycaemic agents requirements may need to be increased (see section 4.4). There may be an enhanced hypoglycaemic effect and masking of warning signs with concurrent administration of insulin and oral antidiabetic drugs. Hypoglycaemia is more likely in Type I than in Type II diabetics and may be associated with delayed recovery. The risk of hyperglycaemia is increased with concomitant use of a beta blocker and a thiazide.

Antihypertensives: Including angiotensin-converting enzyme (ACE) inhibitors and angiotensin-II antagonists; enhanced hypotension. Increased risk of first-dose hypotension with alpha-blockers such as prazosin when administered concomitantly with beta blockers. Cardiodepressant calcium channel blocking agents such as diltiazem, nifedipine and verapamil may induce negative inotropic effects such as severe hypotension, bradycardia, asystole and heart failure avoid concomitant use. Potential for severe hypotension and heart failure with concomitant administration of beta blockers and nisoldipine. Neither the beta-blocker nor the calcium channel blocker should be administered intravenously within 48 hours of discontinuing the other. Potential for enhanced hypotension with concomitant use of diazoxide and beta blockers. There is a potential for an enhanced hypotensive effect when hydralazine and atenolol are administered concomitantly.

Antimalarials: Risk of bradycardia increased with mefloquine.

Anxiolytics and hypnotics: Enhanced hypotensive effect with benzodiazepines.

Cardiac glycosides: Risk of marked bradycardia and AV block with digoxin.

Clonidine: Increased risk of rebound hypertension on withdrawal. Atenolol should be discontinued several days before slowly withdrawing clonidine.

Contrast media: Concomitant use of contrast media with atenolol may increase the risk of hypotension and/or anaphylactic reaction.

Diuretics: Concomitant use of diuretics with beta blockers may increase the risk of hypotension.

Dopaminergics: There is a potential for enhanced hypotension when atenolol and methyldopa are administered concomitantly.

Ergot alkaloids; Increased peripheral vasoconstriction - avoid concomitant use.

Moxisylyte: Increased risk of severe postural hypotension.

Muscle relaxants: Increases or decreases in the extent of neuromuscular blockade have been seen in patients treated with beta blockers. Some neuromuscular blockers, such as atracurium, may enhance the hypotension and bradycardia associated with anaesthesia in patients taking beta-blockers.

Nitrates: potential for an enhanced hypotensive effect when levodopa and beta blockers are used concomitantly.

Parasympathomimetics: Increased risk of bradycardia and/or hypotension with neostigmine.

Sympathomimetics: Risk of sever hypertension and bradycardia with such agents as adrenaline, noradrenaline and ephedrine. Beta-blockers may also reduce the response to adrenaline in the management of anaphylaxis (see section 4.4).

Theophylline: Atenolol antagonises bronchodilator effect: avoid concomitant use

4.6 Fertility, pregnancy and lactation

Pregnancy

Atenolol crosses the placental barrier and appears in the cord blood. The safety of atenolol if given in early pregnancy has not been established and its use should therefore be avoided. Beta-blockers reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. Administration of atenolol to pregnant women shortly before or during delivery may result in neonatal bradycardia, hypoglycaemia or hypotension.

Administration of atenolol to pregnant women in the management of mild to moderate hypertension has been associated with intra-uterine growth retardation, which is greatest when started in early pregnancy, such as in the second trimester and is related to the duration of treatment. The risk of adverse effects to the foetus or neonate is greater in severely hypotensive pregnancies (including low birth weight).

However, atenolol has been used under close supervision for the treatment of pregnancy-associated hypertension in the third trimester.

Breast-feeding

Atenolol is excreted in breast milk. Breast-feeding can be undertaken but infants should be monitored for bradycardia, respiratory depression, hypotension and hypoglycaemia.

4.7 Effects on ability to drive and use machines

Atenolol has no or negligible influence on the ability to drive and use machines. Occasionally dizziness or fatigue may occur when taking atenolol tablets. If affected, patients should not drive or operate machinery.

4.8 Undesirable effects

Atenolol tablets are well tolerated and the adverse effects experienced are usually a result of its pharmacological action, as with other beta-blockers.

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).

Cardiac disorders:

Common: Bradycardia.

Rare: Heart failure, heart block.

Vascular disorders:

Common: Cold extremities.

Rare: Hypotension, dizziness, syncope, intermittent claudication may be increased if already present, insusceptible patients Raynaud's phenomenon. Rarely, cases of peripheral gangrene have been reported with beta blockers.

Ear disorders:

Vertigo.

Eye disorders:

Rare: Visual disturbances including blurred vision, sore eyes, dry eyes (reversible on withdrawal; discontinuance of the drug should be considered if any such reaction is not otherwise explicable), conjunctivitis.

Gastrointestinal disorders:

Common: Nausea, vomiting, diarrhoea, constipation, abdominal cramps, sclerosing peritonitis and retroperitoneal fibrosis.

Blood and lymphatic system disorders:

Rare: Thrombocytopenia, purpura (thrombocytopenic or nonthrombocytopenic), eosinophilia and leucopenia including agranulocytosis.

Hepato-biliary disorders:

Uncommon: Elevated liver enzymes and/or bilirubin.

Rare: Hepatic toxicity including intrahepatic cholestasis.

Immune system disorders:

Allergic reactions to atenolol, including anaphylaxis may occur.

Metabolism and nutrition disorders:

Lupus-like syndrome. Hyperglycaemia or hypoglycaemia. Non-diabetic patients susceptible to hypoglycaemia include those undergoing regular dialysis, vigorous exercise or prolonged fasting and patients who are long term nutritionally compromised or have liver disease. Atenolol may increase serum triglyceride levels and reduce high-density lipoprotein (HDL) cholesterol levels.

Musculoskeletal and connective tissue disorders:

Myopathies including muscle cramps, arthralgia.

Not known: Lupus-like syndrome.

Nervous system disorders:

Rare: Paraesthesia, peripheral neuritis, lethargy. Atenolol may impair performance in psychomotor tests. There is a potential for memory impairment and/or amnesia to occur with atenolol.

Psychiatric disorders:

Rare: Depression, mood changes, psychoses, hallucinations, confusion, anxiety, abnormal dreams and nightmares.

Respiratory, thoracic and mediastinal disorders:

Rare: Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints, pneumonitis, dyspnoea, pulmonary fibrosis and pleurisy.

Reproductive system and breast disorders:

Rare: Impotence, Peyronie's disease.

Skin and subcutaneous tissue disorders:

Rare: Sweating, pruritus, reversible alopecia, skin rashes (reversible on withdrawal; discontinuance of the drug should be considered if any such reaction is not otherwise explicable), psoriasiform rash or exacerbation of psoriasis, skin necrosis.

Not known: Hypersensitivity reactions, including angioedema and urticaria.

General disorders and administration site conditions:

Common: Fatigue.

Rare: headache, dry mouth, drowsiness, sleep disturbances of the type noted with other beta-blockers. An increase in (A)nti (N)uclear (A)ntibodies has been seen: its clinical relevance is not clear.

Withdrawal: Sudden cessation of therapy with a beta-blocker may exacerbate angina, myocardial infarction, ventricular arrhythmias and sudden cardiac death. (see section 4.4).

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.

4.9 Overdose

Symptoms: Many cases of beta-blocker overdosage are uneventful, but some patients develop severe and occasionally fatal cardiovascular depression. Effects can include dizziness, syncope, hypoglycaemia, bradycardia, cardiac conduction block, hypotension, heart failure, acute cardiac insufficiency and cardiogenic shock. Convulsions, coma, bronchospasm, respiratory depression, and bronchoconstriction can also occur, although infrequently.

Treatment: Absorption of any drug material present in the gastrointestinal tract can be prevented by administration of activated charcoal if the patient presents within one hour of ingestion.

Acute massive overdosage requires hospital management and expert advice should be obtained. Maintenance of a clear airway and adequate ventilation is mandatory. Excessive bradycardia and hypotension may be countered by atropine intravenously. Cardiogenic shock unresponsive to atropine may be treated with an intravenous injection of glucagon. A further dose of glucagon (or an intravenous infusion) may be required if the response is not maintained. If glucagon is not available intravenous isoprenaline or dobutamine are alternatives.

Administration of calcium ions may be considered. A cardiac pacemaker may be used if second or third degree heart block or bradycardia occur. In patients intoxicated with hydrophilic beta-blocking agents, which include atenolol, haemodialysis may be considered. Bronchodilators may be used to treat bronchospasm. Hypoglycaemia may be treated with intravenous glucose.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Selective Beta blocking agents.

ATC code: C07AB

Atenolol is a beta-adrenoceptor blocking agent for use in the management of hypertension and angina pectoris. It is a cardioselective beta-blocker selective for cardiac beta₁ receptors and has no partial agonist or membrane stabilising activity.

Mechanism of action

The mode of action of atenolol and other beta-blockers in the moderation of hypertension is still not fully understood although its effects on plasma renin and cardiac output are probably of primary importance.

Pharmacodynamic effects

Atenolol reduces cardiac output, alters baroreceptor reflex sensitivity and blocks peripheral adrenoceptors. Atenolol has been found to reduce systolic and diastolic blood pressures by about 15% in patients with mild to moderate hypertension. Its beta- adrenoceptor antagonist properties reduce cardiac work. This property improves exercise tolerance in anginal patients.

5.2 Pharmacokinetic properties

Absorption

Atenolol is not completely absorbed from the gastrointestinal tract, its oral bioavailability being of the order 50-60%.

Biotransformation

It is approximately 5% bound to plasma proteins. The plasma half-life of atenolol is about 6 hours. However, the duration of therapeutic effect is much longer than this, allowing once daily dosing.

Elimination

Atenolol is excreted largely unchanged in the urine and its dosage should be adjusted in renal failure

5.3 Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to those already included in other sections.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Calcium Hydrogen Phosphate

Povidone

Starch 1500

Microcrystalline Cellulose

AC-DI-SOL SD 711

Magnesium Stearate

Hydroxypropylmethyl Cellulose 6 CP

Sunset yellow aluminium lake (E 110)

Quinoline yellow aluminium lake (E 104)

Titanium dioxide (E 171)

Polyethylene glycol /Macrogol

Isopropyl alcohol and purified water.

6.2 Incompatibilities

None.

6.3 Shelf life

3years.

6.4 Special precautions for storage

Store in the original package in order to protect from heat, light and moisture.

6.5 Nature and contents of container

Blister packaging (10 tablets/strip) in aluminium foil, subsequently packed in printed cardboard carton containing 30 tablets in each.

Calendar packs:

Blister packaging (14 tablets/strip) in aluminium foil, subsequently packed in printed cardboard carton containing 28 tablets in each.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Clydesdale Pharma Ltd

Unit 3-4 Campbell Court

Campbell Road

Tadley

RG26 5EG

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 51718/0002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19/07/1999

Date of latest renewal: 18/03/2009

10 DATE OF REVISION OF THE TEXT

28/09/2026