Medicinal Products

ATENOLOL ACCORD HEALTHCARE 50 mg

Generic drug of Tenormine
Therapeutic class: Cardiology and angiology
active ingredients: Atenolol, Atenolol, Atenolol
laboratory: Accord Healthcare Ltd

Tablet breackable
box of 90
All forms

Indication

· Hypertension

· Chronic stable angora

· Secondary prevention after acute myocardial infarction: rapid intervention in the first 12 hours.

· Supraventricular arrhythmias:

o paroxysmal supraventricular tachycardia (preventive or curative treatment)

o atrial fibrillation and atrial flutter: in case of insufficient response to the maximum doses of digitalis; in cases where digitalis may be contraindicated or may be associated with an adverse risk / benefit ratio.

· Ventricular arrhythmias:

o Ventricular extrasystoles (preventive or curative treatment), if extrasystoles result from an increase in sympathetic activity

ventricular tachycardias and ventricular fibrillation (preventive treatment), especially when the ventricular anomaly results from significant sympathetic activity.

Dosage ATENOLOL ACCORD HEALTHCARE 50 mg scored tablet box of 90

· Hypertension

· Chronic stable angora

· Secondary prevention after acute myocardial infarction: rapid intervention in the first 12 hours.

· Supraventricular arrhythmias:

o paroxysmal supraventricular tachycardia (preventive or curative treatment)

o atrial fibrillation and atrial flutter: in case of insufficient response to the maximum doses of digitalis; in cases where digitalis may be contraindicated or may be associated with an adverse risk / benefit ratio.

· Ventricular arrhythmias:

o Ventricular extrasystoles (preventive or curative treatment), if extrasystoles result from an increase in sympathetic activity

ventricular tachycardias and ventricular fibrillation (preventive treatment), especially when the ventricular anomaly results from significant sympathetic activity.

Against indications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

· Cardiogenic shock

· Uncontrolled heart failure

Sinus disease (including sinoatrial block)

· Second and third degree heart block

· Untreated pheochromocytoma

· Metabolic acidosis

· Bradycardia (<50 bpm before initiation of treatment)

· Hypotension

· Severe peripheral circulatory disorders

· Floctafenine

· Severe asthma and obstructive chronic bronchopathies, such as airway obstructions

· Intravenous administration of calcium channel blockers (verapamil / diltiazem) is contraindicated in patients who use atenolol (except in the intensive care unit).

Adverse effects Atenolol Accord Healthcare

Within each group frequency, adverse effects should be presented in order of decreasing severity.

The following terminologies have been used to classify the frequency of adverse events.

Very common: ≥1 / 10

Frequency: ≥1 / 100 and <1/10

Uncommon: ≥1 / 1000 and <1/100

Rare: ≥1 / 10, 000 and <1/1000

Very rare: <1 / 10, 000, not known (can not be estimated from available data)

Blood and lymphatic system disorders

Rare: thrombocytopenia, leukopenia

Endocrine disorders

Betablockers may mask the symptoms of thyrotoxicosis or hypoglycaemia.

Psychiatric disorders

Uncommon: sleep disorders

Rare: hallucinations, psychoses, mental confusion, depression, nightmares, anxiety

Nervous system disorders

Rare: headache, dizziness, paresthesia of the extremities

Eye disorders

Rare: decreased vision, impaired vision, dry eye

Heart conditions

Common: bradycardia

Rare: slowing of AV conduction or increase of an existing AV block, worsening of heart failure

Vascular disorders

Common: cold and cyanotic extremities

Rare: hypotension (sometimes associated with syncope), Raynaud's phenomenon, increase of an existing intermittent claudication.

Respiratory, thoracic and mediastinal disorders

Rare: Bronchospasm in patients with bronchial asthma or a history of asthmatic disorders.

Gastrointestinal disorders

Common: gastrointestinal problems, nausea, vomiting, diarrhea and constipation.

Rare: dry mouth.

Skin and subcutaneous tissue disorders

Rare: rash, alopecia, skin reactions similar to psoriasis, worsening of psoriasis, purpura

Not known: hypersensitivity reactions, including angioedema and urticaria.

General disorders and administration site conditions

Frequent: fatigue, sweating

investigations

Very rare: an increase in anti-nuclear antibodies has been observed; its clinical relevance is not established.

Hepatobiliary disorders

Uncommon: Elevations of transaminase levels.

Rare: hepatic toxicity in particular, intrahepatic cholestasis.

Disorders of the reproductive organs and breast

Rare: helplessness

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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