Medicinal Products

ATENOLOL SANDOZ 100 mg

Generic drug of Tenormine
Therapeutic class: Cardiology and angiology
active ingredients: Atenolol, Atenolol, Atenolol
laboratory: Sandoz

Divisible coated tablet
box of 30
All forms

Indication

· Hypertension.

· Prophylaxis of stress angina attacks.

· Acute myocardial infarction: relay of injectable form IV (Atenolol reduces mortality in the acute phase of myocardial infarction Treatment is instituted at the latest before the 12th hour).

· Supraventricular arrhythmias:

o paroxysmal supraventricular tachycardias (as preventive or curative treatment),

o atrial fibrillation or flutter in case of insufficient response to digitalis at maximum doses and in cases where digitalis are contraindicated or have an unfavorable benefit / risk ratio,

· Ventricular arrhythmias:

o Ventricular extrasystoles (preventive or curative treatment) in case of extrasystoles resulting from an increase in sympathetic activity,

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

Dosage ATENOLOL SANDOZ 100 mg film-coated tablet scored box of 30

· Hypertension.

· Prophylaxis of stress angina attacks.

· Acute myocardial infarction: relay of injectable form IV (Atenolol reduces mortality in the acute phase of myocardial infarction Treatment is instituted at the latest before the 12th hour).

· Supraventricular arrhythmias:

o paroxysmal supraventricular tachycardias (as preventive or curative treatment),

o atrial fibrillation or flutter in case of insufficient response to digitalis at maximum doses and in cases where digitalis are contraindicated or have an unfavorable benefit / risk ratio,

· Ventricular arrhythmias:

o Ventricular extrasystoles (preventive or curative treatment) in case of extrasystoles resulting from an increase in sympathetic activity,

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

Against indications

This medicine MUST NEVER be used in the following cases:

· Hypersensitivity to the active substance or to any of the excipients listed under Composition,

· Asthma and chronic obstructive pulmonary disease in their severe forms,

· Heart failure not controlled by treatment,

· Cardiogenic shock,

· Non-paired second and third degree atrioventricular blocks,

· Prinzmetal's angina (in pure forms and monotherapy),

· Sinus disease (including sinoatrial block),

· Bradycardia (<45-50 beats per minute),

· Raynaud's phenomenon and peripheral arterial disorders in their severe forms,

· Untreated pheochromocytoma,

· Hypotension,

· History of anaphylactic reaction,

· Breastfeeding,

· Combination with floctafenine, sultopride (see section 4.5).

Adverse effects Atenolol Sandoz

Clinically

The most frequently reported:

· Asthenia,

· Cooling of the ends,

· Bradycardia, severe if any,

· Digestive disorders (gastralgia, nausea, vomiting),

· incapacity.

Much less often:

· Slowing of atrioventricular conduction or intensification of an existing atrioventricular block,

· heart failure,

· Blood pressure drop,

· Bronchospasm,

· Hypoglycemia,

· Raynaud's syndrome,

· Aggravation of an existing intermittent claudication,

· Various skin manifestations including psoriasiform eruptions.

Biologically

In rare cases, it has been possible to observe the appearance of antinuclear antibodies which only exceptionally accompany clinical manifestations such as lupus syndrome and cede at the end of treatment.

Exceptional elevations of hepatic transaminases (as well as some cases of intrahepatic cholestasis).

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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