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Atenolol 50mg Film-Coated Tablets (Wockhardt UK Ltd)

SPC Table of Contents
1. Name of the medicinal product

Atenolol 50mg Film-Coated Tablets or Totamol 50mg Film-Coated Tablets

2. Qualitative and quantitative composition

Atenolol 50mg

For excipients, see 6.1

3. Pharmaceutical form

Film-Coated Tablets

4. Clinical particulars
4.1 Therapeutic indications

Atenolol is recommended for the treatment of hypertension, angina pectoris, cardiac dysrhythmia, and for early intervention in the acute phase of myocardial infarction.

4.2 Posology and method of administration

Dosage

Adults:

Hypertension: Usually 50mg daily.

Angina: Usually 100mg daily or 50mg twice daily.

Dysrhythmias: Following control with intravenous atenolol, a suitable oral maintenance dosage is 50-100mg daily, given as a single dose.

Myocardial Infarction: Following treatment with intravenous atenolol, oral atenolol 50mg may be given approximately 15 minutes later, provided no untoward effects occur from the intravenous dose. This should be followed by a further 50mg orally 12 hours after the intravenous dose and subsequent dosage maintained, after a further 12 hours, with 100mg daily. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, atenolol should be discontinued.

Renal impairment: The dose may need to be reduced.

Hepatic dysfunction: The dose may need to be reduced.

Elderly Patients:

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

Children under 12 years of age:

There are inadequate clinical data available on the use of atenolol in children and for this reason it is not recommended.

4.3 Contraindications

Atenolol is contra-indicated in patients with a known hypersensitivity to atenolol, severe bradycardia, second degree or third degree heart block, uncontrolled heart failure, Prinzmetal's angina hypotension, severe peripheral vascular disease (including intermittent claudication), sick sinus syndrome, cardiogenic shock, phaeocromocytoma (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 4.4 Special Warnings and Precautions for Use), 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 4.8, Undesirable Effects. 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 4.5, Interactions).

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 hypertenstion (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 4.5 Interactions).

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 4.2, Posology and Method of Administration).

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 4.4 Special Warnings and Precautions for Use).

Analgesics: Antihypertensive effects of beta-blockers may be impaired by non-steroidal anti-inflammatory drugs (NSAIDs), particularly 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: (eg, 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 4.4 Special Warnings and Precautions for Use). 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. 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 severe 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 4.4 Special Warnings and Precautions for Use).

Theophylline: Atenolol antagonises bronchodilator effect: avoid concomitant use

4.6 Pregnancy and lactation

Atenolol crosses the placenta. 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 in pregnancy may be associated with reduced foetal growth, 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 effectively under close supervision for the treatment of hypertension in the third trimester.

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

Occasionally dizziness or fatigue may occur when taking atenolol tablets. If affected, patients should not drive or operate machinery

4.8 Undesirable effects

Atenolol is generally well tolerated and most adverse effects are mild.

Cardio disorders: heart failure, heart block, bradycardia

Vascular disorders: hypotension, dizziness, syncope, peripheral vasoconstriction with coldness of the extremities (including exacerbation of intermittent claudication and Raynaud's phenomenon). (see 4.4, Special Warnings and Precautions for Use). Rarely, cases of peripheral gangrene have been reported with beta blockers.

Ear disorders: vertigo.

Eye disorders: 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: nausea, vomiting, diarrhoea, constipation and abdominal cramps, sclerosing peritonitis and retroperitoneal fibrosis.

Blood and lymphatic system disorders: thrombocytopenia, purpura, (thrombocytopenic or nonthrombocytopenic), eosinophilia and leucopenia including agranulocytosis.

Hepatiobiliary disorders: Elevated liver enzymes and/or bilirubin

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: 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: Depression, mood-swings, psychosis, hallucinations, confusion, anxiety nervousness, abnormal dreams and nightmares.

Respiratory, thoracic and mediastinal disorders: bronchospasm, pneumonitis, dyspnoea, pulmonary fibrosis and pleurisy.

Reproductive system and breast disorders: impotence, Peyronie's disease

Skin and subcutaneous tissue disorders: 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 (rarely).

General disorders and administration site conditions: fatigue, headache, dry mouth, drowsiness, sleep disturbances of the type noted with other beta-blockers have been reported rarely. 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 4.4 Special Warnings and Precautions for Use).

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

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.

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. 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

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

Maize Starch

Heavy Magnesium Carbonate

Povidone K30

Sodium Starch Glycollate

Magnesium Stearate

Purified Water

Opadry Orange OY-3455

6.2 Incompatibilities

None known

6.3 Shelf life

Three years

6.4 Special precautions for storage

Do not store above 25°C

Store in the original container

6.5 Nature and contents of container

Strip packs consisting of opaque white or clear UPVC coated with UPVDC, and aluminium foil with heat seal coating on bright side and colourless key coating on dull side. Strip packs contain 28 or 504 tablets.

Polypropylene or polyethylene tablet container of 500 tablets.

6.6 Special precautions for disposal and other handling

None

7. Marketing authorisation holder

Wockhardt UK Ltd

Ash Road North

Wrexham Industrial Estate

Wrexham LL13 9UF

United Kingdom

8. Marketing authorisation number(s)

PL 29831/0018

9. Date of first authorisation/renewal of the authorisation

16/08/2007

10. Date of revision of the text

27/05/2016

Company Information

Wockhardt UK Ltd

Address : Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF

Telephone : +44 (0)1978 661 261

Fax : +44 (0)1978 660 130

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  • atenolol

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