EMCOR Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Emcor 5 mg film-coated tablets. Emcor 10 mg film-coated tablets.
Qualitative and quantitative composition
<u>Emcor 5 mg:</u> Each tablet contains 5 mg Bisoprolol fumarate (equivalent to 4.2mg bisoprolol). <u>Emcor 10 mg:</u> Each tablet contains 10 mg Bisoprolol fumarate (equivalent to 8.4mg bisoprolol). ...
Pharmaceutical form
<u>Emcor 5 mg:</u> Film-coated tablet. Yellowish-white, heart shaped, scored and film-coated tablet. <u>Emcor 10 mg:</u> Film-coated tablet. Pale orange-light orange, heart shaped, scored and film-coated ...
Therapeutic indications
In the management of hypertension and the management of angina pectoris.
Posology and method of administration
Route of administration Oral. Posology Adults The usual dose is 10mg once daily, with a maximum recommended dose of 20mg per day. In some patients 5mg per day may be adequate. Patients with renal or hepatic ...
Contraindications
Bisoprolol is contra-indicated in patients with: acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy cardiogenic shock second or third degree AV block ...
Special warnings and precautions for use
Bisoprolol must be used with caution in: heart failure (the treatment of stable chronic heart failure with bisoprolol has to be initiated with a special titration phase [for details, see SPC for bisoprolol ...
Interaction with other medicinal products and other forms of interaction
Combinations not recommended Calcium antagonists such as verapamil and to a lesser extent diltiazem: Negative influence on contractility and atrio-ventricular conduction. Intravenous administration of ...
Pregnancy and lactation
Pregnancy Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the foetus/newborn. In general, β- blockers reduce placental perfusion, which has been associated with ...
Effects on ability to drive and use machines
In a study with coronary heart disease patients bisoprolol did not impair driving performance. However, due to individual variations in reactions to the drug, the ability to drive a vehicle or to operate ...
Undesirable effects
The following definitions apply to the frequency terminology used hereafter: Very common (≥1/10), Common (≥1/100, to <1/10), Uncommon (≥1/1,000, to <1/100), Rare (≥1/10,000, to <1/1,000), Very rare (<1/10,000), ...
Overdose
Symptoms The most common signs expected with overdosage of a ß-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycaemia. To date few cases of overdose (maximum: ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> β-blocking agents, selective (C07AB07) Mechanism of action Bisoprolol is a potent, highly β<sub>1</sub>-selective adrenoreceptor blocking agent devoid of intrinsic sympathomimetic ...
Pharmacokinetic properties
Bisoprolol is absorbed almost completely from the gastrointestinal tract. Together with the very small first pass effect in the liver, this results in a high bioavailability of approximately 90%. The drug ...
Preclinical safety data
Not applicable.
List of excipients
Silica colloidal anhydrous Magnesium stearate Crospovidone Microcrystalline cellulose Maize starch Calcium hydrogen phosphate anhydrous <u>Coating:</u> Iron oxide red E172 (10mg only) Iron oxide yellow ...
Incompatibilities
None.
Shelf life
5 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Cartons containing aluminium/PVC blister packs of 4, 14 or 28 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Merck Serono (Ireland) Limited, 4045 Kingswood Road, Citywest Business Campus, Dublin 24, Ireland
Marketing authorization number(s)
PA 2286/2/1 PA 2286/2/2
Date of first authorization / renewal of the authorization
Date of First Authorisation: 30<sup>th</sup> June, 1988 Date of latest renewal 30<sup>th</sup> June, 2003
Date of revision of the text
06 November 2020
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