- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6. Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
- Legal category
AdministrationEmcor tablets should be taken in the morning and can be taken with food. They should be swallowed with liquid and should not be chewed.
Special populationsElderly: No dosage adjustment is normally required, but 5 mg per day may be adequate in some patients; as for other adults, dosage may have to be reduced in cases of severe renal or hepatic dysfunction.Children: There is no paediatric experience with bisoprolol, therefore its use cannot be recommended for children.Renal or hepatic impairment: In patients with final stage impairment of renal function (creatinine clearance < 20 ml/min) or liver function, the dose should not exceed 10 mg bisoprolol once daily.
Combinations not recommended Calcium antagonists of the verapamil type and to a lesser extent of the diltiazem type: Negative influence on contractility and atrio-ventricular conduction. Intravenous administration of verapamil in patients on beta-blocker treatment may lead to profound hypotension and atrioventricular block. Centrally acting antihypertensive drugs such as clonidine and others (e.g. methyldopa, moxonodine, rilmenidine): Concomitant use of centrally acting antihypertensive drugs may further decrease the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation). Abrupt withdrawal, particularly if prior to beta-blocker discontinuation, may increase risk of rebound hypertension.
Combinations to be used with caution Calcium antagonists of the dihydropyridine type such as nifedipine: Concomitant use may increase the risk of hypotension, and an increase in the risk of a further deterioration of the ventricular pump function in patients with heart failure cannot be excluded. Class-I antiarrhythmic drugs (e.g. disopyramide, quinidine): Effect on atrio-ventricular conduction time may be potentiated and negative inotropic effect increased Class-III antiarrhythmic drugs (e.g. amiodarone): Effect on atrio-ventricular conduction time may be potentiated. Topical beta-blockers (e.g. eye drops for glaucoma treatment) may add to the systemic effects of bisoprolol. Parasympathomimetic drugs: Concomitant use may increase atrio-ventricular conduction time and the risk of bradycardia. Insulin and oral antidiabetic drugs: Intensification of blood sugar lowering effect. Blockade of beta-adrenoreceptors may mask symptoms of hypoglycaemia. Anaesthetic agents: Attenuation of the reflex tachycardia and increase of the risk of hypotension (for further information on general anaesthesia see also section 4.4). Digitalis glycosides: Reduction of heart rate, increase of atrio-ventricular conduction time. Non-steroidal anti-inflammatory drugs (NSAIDs): NSAIDs may reduce the hypotensive effect of bisoprolol. Beta-sympathomimetic agents (e.g. isoprenaline, dobutamine): Combination with bisoprolol may reduce the effect of both agents. Sympathomimetics that activate both beta- and alpha-adrenoceptors (e.g. noradrenaline, adrenaline): Combination with bisoprolol may unmask the alpha-adrenoceptor-mediated vasoconstrictor effects of these agents leading to blood pressure increase and exacerbated intermittent claudication. Such interactions are considered to be more likely with nonselective beta-blockers. Higher doses of adrenaline may be necessary for treatment of allergic reactions. Concomitant use with antihypertensive agents as well as with other drugs with blood pressure lowering potential (e.g. tricyclic antidepressants, barbiturates, phenothiazines) may increase the risk of hypotension. Moxisylyte: Possibly causes severe postural hypotension.
Combinations to be considered Mefloquine: increased risk of bradycardia Monoamine oxidase inhibitors (except MAO-B inhibitors): Enhanced hypotensive effect of the beta-blockers but also risk for hypertensive crisis.
PregnancyBisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the foetus/newborn. In general, β-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labour. Adverse effects (e.g. hypoglycaemia and bradycardia) may occur in the foetus and newborn infant. If treatment with β-adrenoceptor blockers is necessary, β1-selective adrenoceptor blockers are preferable. Bisoprolol should not be used during pregnancy unless clearly necessary. If treatment with bisoprolol is considered necessary, the uteroplacental blood flow and the foetal growth should be monitored. In case of harmful effects on pregnancy or the foetus alternative treatment should be considered. The newborn infant must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days.
LactationIt is not known whether this drug is excreted in human milk. Therefore, breastfeeding is not recommended during administration of bisoprolol.
Cardiac disorders:Uncommon: AV-conduction disturbances, worsening of pre-existing heart failure, bradycardia.
Vascular disorders:Common: feeling of coldness or numbness in the extremities, hypotension.Uncommon: Orthostatic hypotension.
Metabolism and nutrition disorders:Rare: Increased triglycerides.
Psychiatric disorders:Uncommon: sleep disorders, depression.Rare: nightmares, hallucinations.
Nervous system disorders:Common: dizziness*, headache*.Rare: syncope
Eye disorders:Rare: reduced tear flow (to be considered if the patient uses lenses).Very rare: conjunctivitis.
Ear and labyrinth disorders:Rare: hearing disorders.
Respiratory, thoracic and mediastinal disorders:Uncommon: bronchospasm in patients with bronchial asthma or a history of obstructive airways disease.Rare: allergic rhinitis.
Gastrointestinal disorders:Common: gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation.Hepatobiliary disorders: Rare: increased liver enzymes (ALAT, ASAT), hepatitis.
Skin and subcutaneous tissue disorders:Rare: hypersensitivity reactions (itching, flush, rash).Very rare: beta-blockers may provoke or worsen psoriasis or induce psoriasis-like rash, alopecia.
Musculoskeletal and connective tissue disorders:Uncommon: muscular weakness and cramps.
Reproductive system and breast disorders:Rare: potency disorders.
General disorders:Common: fatigue*.Uncommon: asthenia.*These symptoms especially occur at the beginning of the therapy. They are generally mild and often disappear within 1-2 weeks.
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