Medicinal Products

DETENSIAL 10 mg

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Bisoprolol
laboratory: Merck Sante

Divisible coated tablet
Box of 50
All forms

Indication

- Hypertension.
- Prophylaxis of stress angina attacks.

Dosage DETENSIEL 10 mg Film-coated tablet scored box of 50

Adult s : In both indications, the usual dosage is one tablet of DETENSIEL 10 mg once a day. In some severe cases, the dose may be increased to 20 mg once daily.

The maximum recommended dosage is 20 mg once a day.

In all cases, the dosage must be adapted individually, depending in particular on the heart rate and response to treatment.

Duration of treatment

Treatment with DETENSIEL is usually a long-term treatment.

Treatment with DETENSIEL should not be stopped abruptly as this may lead to transient worsening of the pathology. In patients with ischemic heart disease in particular, treatment should not be stopped abruptly. It is recommended to gradually reduce the dosage.

Special Populations

Renal or hepatic impairment

No dose adjustment is usually required in patients with mild to moderate hepatic or renal impairment. In patients with severe renal impairment (creatinine clearance <20 ml / min) and in patients with severe liver function disorders, it is recommended not to exceed the dose of 10 mg bisoprolol hemifumarate day.

The experience of bisoprolol in patients undergoing renal dialysis is limited; however, there is no evidence that it is necessary to change the dosage.

Elderly

Treatment should be initiated with low doses (5 mg) and under close supervision.

children

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

Administration

DETENSIEL 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

DETENSIEL is contraindicated in the following cases:

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

· Cardiogenic shock,

· Non-paired second or third degree atrioventricular blocks,

· Sinus disease,

· Sino-atrial block,

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

· Hypotension (systolic blood pressure less than 100 mm Hg),

· Severe asthma or obstructive chronic broncho-pneumopathies, in their severe forms,

Occlusive peripheral arterial disorders and Raynaud's syndrome in their severe forms,

· Untreated pheochromocytoma (see Warnings and Precautions for Use section )

· Metabolic acidosis.

DETENSIEL is contraindicated in patients with hypersensitivity to bisoprolol or any of the excipients (see section Composition ).

Detensiel side effects

The expected adverse effects with bisoprolol due to its mode of action of beta-1-selective type include bradycardia, hypotension, bronchospasm in predisposed patients and worsening of preexisting heart failure.

The frequency terms used hereinafter are as follows.

Frequent (³ 1% and <10%), infrequent (³ 0.1% and <1%), rare (³ 0.01% and <0.1%), very rare (£ 0.01%).

Heart conditions:

Uncommon: disorders of atrioventricular conduction, worsening of pre-existing cardiac insufficiency, bradycardia.

investigations

Rare: elevated triglycerides, elevated liver enzymes (ALT, ASAT)

Nervous system disorders:

Common: 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 impairment

Respiratory, thoracic and mediastinal disorders:

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

Rare: allergic rhinitis

Gastrointestinal disorders:

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

Skin and subcutaneous tissue disorders:

Rare: Hypersensitivity reactions such as pruritus, flushing, rash.

Very rare: alopecia, beta-blockers can cause or aggravate psoriasis or induce a psoriasiform rash.

Musculoskeletal and systemic disorders

Uncommon: muscle weakness, cramps

Vascular disorders:

Common: feeling cold or numb in the extremities, hypotension especially in patients with heart failure

General disorders:

Frequent: tiredness *

Uncommon: asthenia.

Hepatobiliary disorders:

Rare: hepatitis.

Disorders of the reproductive organs and the breast:

Rare: impotence.

Psychiatric disorders

Uncommon: depression, sleep disorders

Rare: nightmares, hallucinations

* These symptoms appear especially at the beginning of treatment. They are usually mild and usually go away in one to two weeks.

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. Healthcare 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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