Medicinal Products

BISOCE Ge 3.75 mg

Cardensiel Generic Drug
Therapeutic class: Cardiology and angiology
active ingredients: Bisoprolol
laboratory: Mylan

Divisible coated tablet
Box of 30
All forms

Indication

Treatment of stable chronic heart failure with reduction of left ventricular systolic function in addition to angiotensin converting enzyme (ACE) inhibitors and diuretics, and possibly digitalis (for more information, see section on Pharmacodynamic properties ) .

Dosage BISOCE Ge 3.75 mg Film-coated tablet scored box of 30

Standard treatment for chronic heart failure is a conversion enzyme inhibitor (or an angiotensin receptor blocker for ACE intolerance), a beta-blocker, diuretics, and if necessary, cardiac glycosides. Patients should be stable (without acute episode) at initiation of bisoprolol therapy.

It is recommended that treatment be provided by a physician experienced in the management of patients with chronic heart failure.

Transient worsening of heart failure, hypotension or bradycardia may occur during the titration period and thereafter.

Dosage

Period of titration

The treatment of chronic stable heart failure with bisoprolol requires a titration period.

The dosage should be increased gradually as follows:

· 1.25 mg once daily for 1 week; if the drug is well tolerated, increase to;

· 2.5 mg once a day for another week; if the drug is well tolerated, increase to;

· 3.75 mg once a day for another week; if the drug is well tolerated, increase to;

· 5 mg once daily for the next 4 weeks; if the drug is well tolerated, increase to;

· 7.5 mg once daily for the next 4 weeks; if the drug is well tolerated, increase to;

· 10 mg once daily in maintenance treatment.

The maximum recommended dosage is 10 mg once a day.

Monitoring of vital constants (heart rate, blood pressure) and symptoms of worsening heart failure is recommended during the titration period. Symptoms may already appear from the first day after initiation of treatment.

Modification of treatment

If the maximum recommended dose is poorly tolerated, a gradual decrease in dose may be considered.

In case of transient worsening of heart failure, hypotension or bradycardia, it is recommended to review the dosage of concomitant medications. It may also be necessary to temporarily reduce the dose of bisoprolol or to consider stopping treatment.

Resuming treatment and / or increasing the dose of bisoprolol should always be considered as soon as the patient is stable again.

If discontinuation is considered, a gradual dose reduction is recommended as a sudden interruption may result in acute deterioration of the patient's condition.

The treatment of chronic stable heart failure with bisoprolol is usually a long-term treatment.

Renal or hepatic impairment

There are no data on the pharmacokinetics of bisoprolol in patients with hepatic or renal impairment who have chronic heart failure. It is therefore necessary to increase the dosage with the greatest caution in these patients.

Elderly

It is not necessary to adjust the dosage.

Pediatric population

As no data are available with bisoprolol in pediatric patients, its use can not be recommended in pediatric patients.

Administration mode

Bisoprolol tablets should be taken in the morning, before, during or after breakfast.

They should be swallowed with a little liquid, and should not be chewed.

Against indications

Bisoprolol is contraindicated in patients with chronic heart failure in the following cases:

· Acute heart failure or during episodes of decompensation of heart failure, requiring intravenous inotropic treatment;

· Cardiogenic shock;

· 2nd and 3rd degree atrioventricular blocks;

· Sinus disease;

· Sino-atrial block;

· Symptomatic bradycardia;

· Symptomatic hypotension;

· Severe asthma, or chronic obstructive pulmonary disease in their severe forms;

· Severe forms of occlusive peripheral arterial disorders or severe forms of Raynaud's phenomenon;

· Untreated pheochromocytoma (see Warnings and Precautions ) section

· Metabolic acidosis;

Hypersensitivity to bisoprolol or to any of the excipients listed under Composition .

Side effects Bisoce GE

The frequency terms used hereinafter have the following meanings:

Very common (≥ 1/10)

Frequent (≥ 1/100, <1/10)

Uncommon (≥ 1/1000, <1/100)

Rare (≥ 1/10 000, <1/1000)

Very rare (<1 / 10, 000)

Heart conditions:

Very common: bradycardia.

Common: aggravation of heart failure.

Uncommon: disorders of atrioventricular conduction.

Investigations:

Rare: elevation of triglycerides, elevation of liver enzymes (ALT, ASAT).

Nervous system disorders:

Frequent: dizziness, headache.

Rare: syncope.

Eye disorders:

Rare: lacrimal dryness (to be taken into account if the patient wears lenses).

Very rare: conjunctivitis.

Affections of the ear and labyrinth:

Rare: hearing problems.

Respiratory, thoracic and mediastinal disorders:

Uncommon: Bronchospasm in patients with asthma or with a history of obstructive airways.

Rare: allergic rhinitis.

Gastrointestinal disorders:

Common: Gastrointestinal disorders such as nausea, vomiting, diarrhea, constipation.

Skin and subcutaneous tissue disorders:

Rare: Hypersensitivity reactions (pruritus, flush, rash).

Very rare: alopecia. Beta-blockers can cause or aggravate psoriasis or induce psoriasiform rash.

Musculoskeletal and connective tissue disorders:

Uncommon: muscle weakness and cramps.

Vascular disorders:

Common: feeling cold or numb in extremities, hypotension

Uncommon: orthostatic hypotension.

General disorders:

Frequent: asthenia, fatigue.

Hepatobiliary disorders:

Rare: hepatitis.

Disorders of the reproductive organs and the breast:

Rare: impotence.

Psychiatric disorders:

Uncommon: sleep disorders, depression.

Rare: nightmares, hallucinations.

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