European PSUR Work Sharing Core Safety Profile

European PSUR Work Sharing Core Safety Profile



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4.1Therapeutic Indications

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4.2Posology and Method of Administration

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Cardiogenic shock is an absolute contraindication. Extreme caution is required in patients with blood pressures of the order of 100/60mmHg or below. Acebutololis also contraindicated in patients with second and third degree heart block, sick sinus syndrome, marked bradycardia (<45-50 bpm), uncontrolled heart failure, metabolic acidosis, severe .peripheral circulatory disorders, hypersensitivity to acebutolol, any of the excipients or to beta blockers, and untreated phaeochromocytoma

4.4Special Warnings and Precautions for Use

Renal impairment is not a contraindication to the use of acebutololwhich has both renal and non-renal excretory pathways. Some caution should be exercised when administering high doses to patients with severe renal failure as accumulation could possibly occur in these circumstances.

The dosage frequency should not exceed once daily in patients with renal impairment. As a guide, the dosage should be reduced by 50% when glomerular filtration rates are between 25-50ml/min and by 75% when they are below 25ml/min (see Section 4.2).

Drug-induced bronchospasm is usually at least partially reversible by the use of a suitable agonist.

Although cardio-selective beta blockers may have less effect on lung function than non-selective beta blockers, as with all beta blockers they should be avoided in patients with obstructive airways disease unless there are compelling clinical reasons for their use. Where such reasons exist, cardio-selective beta-blockers should be used with the utmost care.

Beta-blockers may induce bradycardia. In such cases, the dosage should be reduced.

They may be used with care in patients with controlled heart failure (see Section 4.3).

Use with caution in patients with Prinzmetal’s angina.

Beta blockers may aggravate peripheral circulatory disorders. They may mask signs of thyrotoxicosis and hypoglycaemia. They should only be used in patients with phaeochromocytoma with comcomitant alpha-adrenoceptor therapy.

Patients with known psoriasis should take beta-blockers only after careful consideration.

Beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions.

Withdrawal of treatment by beta blockers should be achieved by gradual dosage reduction; this is especially important in patients with ischaemic heart disease.

When it has been decided to interrupt beta-blockade prior to surgery, therapy should be discontinued for at least 24 hours. Continuation of therapy reduces the risk of arrhythmias but the risk of hypotension may be increased. If treatment is continued, caution should be observed with the use of certain anaesthetic drugs. The patient may be protected against vagal reactions by intravenous administration of atropine.

4.5Interaction with other medicinal products and other forms of interaction

Acebutolol should not be used with verapamil or within several days of verapamil therapy (and vice versa). Use with great care with any other calcium antagonists, particularly diltiazem.

Class I anti-arrhythmic drugs (such as disopyramide) and amiodarone may increase atrial conduction time and induce negative inotropic effects when used concomitantly with beta-blockers.

In patients with labile and insulin-dependent diabetes, the dosage of the hypoglycaemic agent (ie insulin or oral diabetic drugs) may need to be reduced. However beta-blockers have also been known to blunt the effect of glibenclamide. Beta-adrenergic blockade may also prevent the appearance of signs of hypoglycaemia (tachycardia, see Section 4.4).

Cross reactions due to displacement of other drugs from plasma protein binding sites are unlikely due to the low degree of plasma protein binding exhibited by acebutolol and diacetolol.

If a beta-blockeris used concurrently with clonidine the latter should not be withdrawn until several days after the former is discontinued.

Acebutolol may antagonize the effect of sympathomimetic and xanthine bronchodilators.

Concurrent use of digoxin and beta-blockers may occasionally induce serious bradycardia. The anti-hypertensive effects of beta-blockers may be attenuated by non-steroidal anti-inflammatory agents.

Concomitant administration of tricyclic antidepressants, barbiturates and phenothiazines as well as other anti-hypertensive agents may increase the blood pressure lowering effect of beta-blockers.

There is a theoretical risk that concurrent administration of monoamine oxidase inhibitors and high doses of beta-blockers, even if they are cardio-selective, can produce hypertension.

Acebutolol therapy should be brought to the attention of the anaesthetist prior to general anaesthesia (see Section 4.4). If treatment is continued, special care should be taken when using anaesthetic agents causing myocardial depression such as ether, cyclopropane and trichlorethylene.

4.6Fertility, Pregnancy and Lactation

Pregnancy: Acebutololshould not be administered to female patients during the first trimester of pregnancy unless the physician considers it essential. In such cases the lowest possible dose should be used.

Beta-blockers administered in late pregnancy may give rise to bradycardia, hypoglycaemia and cardiac or pulmonary complications in the foetus/neonate.

Beta-blockers can reduce placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries.

Animal studies have shown no teratogenic hazard.


Acebutolol and its active metabolites are excreted in human milk and effects have been shown in breastfed newborns/infants of treated mothers. {Invented name} should not be used during breast-feeding.

4.7Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed.As with all beta-blockers, dizziness or fatigue may occur occasionally. This should be taken into account when driving or operating machinery.

4.8Undesirable Effects

Adverse reactions associated with acebutolol during controlled clinical trials in patients with hypertension, angina pectoris or arrhythmia (1002 patients exposed to acebutolol)are presented by system organ class and by decreasing order of frequency.

The frequency of the events “anti-nuclear antibody” and “lupus like syndrome” was found from 1440 patients suffering from hypertension, angina pectoris or arrhythmia and exposed to acebutolol in open or double blind studies performed in the United States.

Frequencies are defined as: 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).

When the exact frequency of the event was not reported, the frequency category assigned is “not known” (ADRs with *).

Adverse reactions reported from postmarketing experience are also listed. These adverse reactions are derived from spontaneous reports and therefore, the frequency of these adverse reactions is “not known” (cannot be estimated from the available data).

The most frequent and serious adverse reactionsof acebutolol are related to the beta-adrenergic blocking activity. The most frequent reported clinical adverse reactions are fatigue and gastrointestinal disorders. Among the most serious adverse reactions are cardiac failure, atrioventricular block and bronchospasm. Abrupt withdrawal as for all beta-blockers may exacerbate angina pectoris and precaution is especially required in patients with ischaemic heart disease (see Section 4.4).

Immune system disorders / Very common / Antinuclear antibody
Uncommon / Lupus like syndrome
Psychiatric disorders / Common / Depression, nightmare
Not known / Psychoses, hallucinations, confusion, loss of libido*, sleep disorder
Nervous system disorders / Very common / Fatigue
Common / Dizziness, headache
Not known / Paraesthesia*, central nervous system disorder
Eye disorders / Common / Visual impairment
Not known / Dry eye*
Cardiac disorders / Not known / Cardiac failure*, atrioventricular block first degree, increase of an existing atrioventricular block, bradycardia*
Vascular disorders / Not known / Intermittent claudication, Raynaud’s syndrome, cyanosis peripheral and peripheral coldness,hypotension*
Respiratory, thoracic and mediastinal disorders / Common / Dyspnoea
Not known / Pneumonitis, lung infiltration, bronchospasm
Gastrointestinal disorders / Very common / Gastrointestinal disorders
Common / Nausea, diarrhoea
Not known / Vomiting*
Skin and subcutaneous tissue disorders / Common / Rash
General disorders and administration site condition / Not known / Withdrawal syndrome (see Section 4.4)


In the event of excessive bradycardia or hypotension, 1mg atropine sulphate administered intravenously should be given without delay. If this is insufficient it should be followed by a slow intravenous injection of isoprenaline (5mcg per minute) with constant monitoring until a response occurs. In severe cases of self-poisoning with circulatory collapse unresponsive to atropine and catecholamines the intravenous injection of glucagon 10-20mg may produce a dramatic improvement. Cardiac pacing may be employed if bradycardia becomes severe.

Judicious use of vasopressors, diazepam, phenytoin, lidocaine, digoxin and bronchodilators should be considered depending on the presentation of the patient. Acebutolol can be removed from blood by haemodialysis. Other symptoms and signs of overdosage include cardiogenic shock, AV block, conduction defects, pulmonary oedema, depressed level of consciousness, bronchospasm, hypoglycaemia and rarely hyperkalaemia.


5.1Pharmacodynamic Properties

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5.2Pharmacokinetic Properties

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5.3Pre-Clinical Safety Data

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6.1List of Excipients

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6.4Special Precautions for Storage

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6.5Nature and contents of Container

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6.6Special precautions for disposal and handling

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