Hypertension.

Angina chronic stable.

Orally.

The dosage should be adjusted individually. It is recommended to start with the lowest dose possible. In some patients, 5 mg per day may suffice. The usual dosage is: 10 mg once daily and the maximum recommended dose of 20 mg daily.
The tablet should be taken on the morning and swallowed with a sufficient amount of liquid (a glass of water for example). The tablet may be taken with food.

Patients with renal insufficiency

In patients with renal insufficiency, severe (creatinine clearance, less than 20 ml / min), the dosage should not exceed 10 mg of bisoprolol once daily. This dosage may optionally be divided by 2.

Patients with severe hepatic impairment

No dosage adjustment is necessary, however, strict medical monitoring is recommended. In the case of severe hepatic insufficiency, the dosage should not exceed 10 mg of bisoprolol once a day.
Elderly subjects

As a general rule, no dosage adjustment is necessary. It is advisable to start the treatment at the dosage as low as possible.

Children under 12 and adolescents

Since this medicinal product has not been used in pediatrics, its use is not recommended.
Stop processing

Treatment should not be interrupted abruptly (see Warnings and Precautions for Use). The dosage should be decreased gradually by reducing it by half each week.
Beige, marbled, round and convex scored tablet with the following marking: "BI" in the center, at the top, with a scored bar and number "10" below.

The tablets may be divided into two equal half-doses.

Bisoprolol hemifumarate is a beta-blocker having a high affinity for β-1 receptors, without activity, intrinsic sympathomimetic, nor membrane stabilizing effect. It has only a weak affinity: for the β-2 receptors of the smooth muscles of the bronchi and the vessels and for the intervening β-2 receptors, in the metabolic regulation. As a result, bisoprolol hemifumarate does not generally modify airway resistance and has no metabolic effects related to action on β-2 receptors. Β-1 selectivity of bisoprolol Extends beyond the therapeutic doses

As with other beta-1-blockers, its mechanism of action in hypertension is not fully known. However, we know that bisoprolol strongly decreases plasma renin activity

In acute administration in patients with ischemic heart disease without chronic heart failure, bisoprolol hemifumarate decreases heart rate and volume, systolic ejection, and thus cardiac output and eating habits, oxygen. In chronic administration, peripheral resistances, initially high, decrease. Therefore, bisoprolol is effective in decreasing or suppressing symptoms.

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

· Cardiogenic shock

· Second or third degree (non-paired) atrio-ventricular block

· Sinus Disease

· Sino-atrial block

· Symptomatic bradycardia

· Symptomatic hypotension

· Severe asthma or obstructive pulmonary disease, severe chronic

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

· Metabolic acidosis

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

· Hypersensitivity to bisoprolol or any of the excipients (see section Composition).
Warnings

Treatment with bisoprolol should never be abruptly discontinued, particularly in patients with ischemic heart disease unless there is a formal indication. This can lead to a transient worsening of cardiac disorders (see section Dosage and mode of administration). The initiation of bisoprolol treatment requires regular monitoring. For more information, see Dosage and mode of administration.

Precautions for use

Bisoprolol should be used with caution in patients with hypertension or angina associated with cardiac insufficiency

Bisoprolol should be used with caution in the following cases

· Diabetes with significant fluctuations in blood sugar, symptoms of hypoglycaemia (eg tachycardia, palpitations or sweating) can be masked

· Strict fasting

· Desensitization treatment in progress. As with other beta-blockers, bisoprolol may increase both sensitivity to allergens and the severity of anaphylactic reactions Adrenaline therapy may not always achieve the expected therapeutic effect. Code>
· First degree atrioventricular block

· Prinzmetal angina

· Peripheral arterial disorders: symptoms may be observed, especially at the beginning of treatment.

In patients with a history of psoriasis or with psoriasis, beta-blockers such as bisoprolol should be administered only after a thorough assessment of the benefit / risk ratio. >

Symptoms of thyrotoxicosis may be masked when treated with bisoprolol.

In case of pheochromocytoma, bisoprolol should not be administered before the alpha-blocking treatment.

In patients under general anesthesia, beta-blocker decreases the incidence of arrhythmias and myocardial ischemia during induction of anesthesia, intubation and post-operative period. It is currently recommended to continue beta-blocker treatment during the period of surgery The anesthesiologist should be advised of taking beta-blocker therapy because of its potential, Other medications, resulting in brady-arrhythmias, decreased tachycardia, reflex and reflex capacity of compensation in case of blood loss. If discontinuation of beta-blocker therapy appears to be necessary, prior to surgery, stop should be phased out and completed 48 hours before anesthesia. >
In the case of asthma or other chronic obstructive airway diseases which may become symptomatic, a bronchodilator treatment should be administered concomitantly. An increase in airway resistance may occur, occasionally in asthmatic patients requiring an increase in the dose of beta-2-stimulants

This medicine contains lactose and is not recommended for use in patients with galactose intolerance, Lapp lactase deficiency or malabsorption syndrome, glucose or galactose (hereditary or rare diseases). Br>

Sportsmen

The attention of athletes is drawn to the fact that this specialty contains an active ingredient which can induce a positive reaction from the tests carried out during the doping controls. Code>
Associations, deprecated

+ Calcium antagonists of verapamil type or, to a lesser extent, diltiazem type

Negative effect on contractility and atrioventricular conduction: Intravenous administration of verapamil in patients on beta-blockers may induce severe hypotension and atrioventricular block.

+ Anti-hypertensive agents of central action (eg clonidine, methyldopa, moxonidine, rilmenidine)


+ Digital;
Reduced frequency, cardiac, increased conduction time, atrioventricular.

+ Non-steroidal anti-inflammatory drugs (NSAIDs)

The hypotensive action of bisoprolol may be decreased.

+; Beta-sympathomimetic drugs (eg isoprenaline, dobutamine)

The combination with bisoprolol may decrease the effect of both drugs.

Sympathomimetic drugs that activate α- and β-adrenergic receptors (eg, noradrenaline, adrenaline)

The association with bisoprolol may reveal the vasoconstrictive, α-adrenergic effect of these drugs, leading to hypertension and aggravation of intermittent claudication. These interactions are considered as more likely with non-selective beta-blockers.

Anti-hypertensives, or medicinal products that may induce hypotension (eg tricyclic antidepressants, barbiturates, phenothiazines)

The risk of hypotension may be increased.

Associations to be taken into account

+; Mefloquine

Increased risk of bradycardia

+; Monoamine oxidase inhibitors (except MAO-B)

Increase in hypotensive effect of beta-blockers, but also risk of hypertensive crisis

+; Rifampicin

Low decrease in the half-life of bisporolol possibly due to induction of hepatic metabolism of medicinal products Generally no dosage adjustment is necessary
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+; Derivatives of ergotamine

Exacerbation of circulatory disorders, peripheral.

Without object.

The most frequent signs of overdosage with a beta-blocker are bradycardia, hypotension, bronchospasm, acute heart failure, and hypoglycaemia. There is little experience with overdosage with bisoprolol, only a few cases have been reported. They resulted in bradycardia and / or hypotension. All patients recovered. There are wide inter-individual variations in sensitivity to a single, high dose of bisoprolol and patients with cardiac insufficiency are probably very sensitive.
Given the expected pharmacological actions and recommendations for other beta-blockers, the following general measures should be considered when clinically justified:
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Bradycardia: administration of atropine, I.V. If the response is inadequate, isoprenaline or another drug with positive chronotropic properties may be given with caution. Under certain circumstances, the installation of a pacemaker may be necessary.

Hypotension: intravenous solutions and vasopressors should be administered. Intravenous glucagon may be useful.

Atrioventricular block (2nd or 3rd degree) Patients should be monitored carefully and treated with isoprenaline infusion or temporary pacemaker.

Acute aggravation of heart failure: administration of diuretics, inotropic agents, vasodilators by I.V.

Bronchospasm: administration of a bronchodilator treatment, such as isoprenaline, sympathomimetic beta-2 drugs and / or aminophylline.

Hypoglycemia, glucose I.V. administration

Limited data suggest that bisoprolol is difficult to dialyze

Pregnancy

Bisoprolol has pharmacological properties which may cause adverse effects on pregnancy and / or the fetus / newborn. In general, beta-blockers decrease placental perfusion, this effect has been associated with delayed growth, death, intrauterine, abortion or early labor. Adverse effects (eg, hypoglycaemia, bradycardia) may occur in the fetus, and the newborn. If beta-blocker therapy is required, a beta-selective beta-blocker should be preferred.
Bisoprolol should not be used during pregnancy unless needed. If treatment with bisoprolol is necessary, it is recommended to monitor uteroplacental blood flow and fetal growth. In case of harmful effects on pregnancy or the fetus, alternative treatment is recommended. The newborn should be closely monitored. Symptoms of hypoglycemia and bradycardia usually occur during the first 3 days of life.
Breastfeeding

There are no data on the excretion of bisoprolol in milk or on the safety of bisoprolol in neonates. Therefore, breast-feeding is not recommended during treatment with bisoprolol.


Common (≥ 1% and