BISOPROLOL Film-coated tablets (2019)
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Περιεχόμενα
Name of the medicinal product
Bisoprolol 5 mg Film-coated Tablet.
Qualitative and quantitative composition
Each film-coated tablet contains 5 mg Bisoprolol fumarate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet. White to off white, round, biconvex, film coated tablets, debossed b2 on one side and break line on other side. Tablet diameter is approximately 7.2 mm. The tablet can be divided into ...
Therapeutic indications
Treatment of Hypertension. Treatment of stable chronic angina. Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and ...
Posology and method of administration
Bisoprolol fumarate tablet should be taken in morning and can be taken with food in morning. They should be swallowed in liquid and should not be chewed. Posology Treatment of hypertension and chronic ...
Contraindications
Bisoprolol is contraindicated in chronic heart failure patients with: acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy cardiogenic shock second or ...
Special warnings and precautions for use
Special warnings Applies only to chronic heart failure The treatment of stable chronic heart failure with bisoprolol has to be initiated with special titration phase (see section 4.2). Applies to all indications ...
Interaction with other medicinal products and other forms of interaction
Combinations not recommended Applies only to chronic heart failure Class I antiarrhythmic drugs (e.g. quinidine, disopyramide; lidocaine, phenytoin; flecainide, propafenone): Effect on atrio-ventricular ...
Pregnancy and lactation
Pregnancy Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the fetus/newborn. In general, beta-adrenoceptor blockers reduce placental perfusion, which has been ...
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, <1/10) Uncommon (≥1/1,000, <1/100) Rare (≥1/10,000, <1/1,000) Very rare (<1/10,000) Psychiatric ...
Overdose
The most common signs expected with overdose of a beta-blocker are bradycardia, hypotension, bronchospasm, acute cardiac insufficiency and hypoglycaemia. There is limited experience with overdose of bisoprolol, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta blocking agents, selective ATC Code: C07AB07 Mechanism of action Bisoprolol is a potent highly beta1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating ...
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 plasma ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenicity. Like other beta-blockers, bisoprolol ...
List of excipients
Core Tablet: Cellulose microcrystalline Sodium starch glycolate(Type-A) Povidone K-30 Silica colloidal anhydrous Magnesium stearate (E470b) Coating: Hypromellose E-15 (E464) Macrogol 400 (E553) Titanium ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
PVC/PVDC-Alu Blister or ALU-ALU Blister in Pack sizes of 20, 28, 30, 50, 56, 60, 90 and 100 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Marketing authorization number(s)
PL 20075/0317
Date of first authorization / renewal of the authorization
21/12/2011
Date of revision of the text
05/03/2019
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