BISOPROLOL Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

1.25 mg tablet only: Bisoprolol fumarate 1.25 mg film-coated tablets. 2.5 mg tablet only: Bisoprolol fumarate 2.5 mg film-coated tablets. 3.75 mg tablet only: Bisoprolol fumarate 3.75 ...

Qualitative and quantitative composition

1.25 mg tablet only: Each tablet contains 1.25 mg of bisoprolol fumarate. 2.5 mg tablet only: Each tablet contains 2.5 mg of bisoprolol fumarate. 3.75 mg tablet only: Each tablet contains ...

Pharmaceutical form

Film-coated tablet (tablet). 1.25 mg tablet only: White, oval, biconvex film coated tablets; approximately 9 mm x 7 mm; BL & 1 engraved on one face of the tablet; M engraved on the other face of ...

Therapeutic indications

Treatment of hypertension. Treatment of chronic stable angina pectoris. Treatment of stable chronic heart failure with reduced systolic ventricular function in addition to ACE inhibitors, and diuretics, ...

Posology and method of administration

Posology Treatment of hypertension and chronic stable angina pectoris Adults The dosage should be individually adjusted. It is recommended to start with 5 mg per day. The usual dose is 10 mg once daily ...

Contraindications

Bisoprolol is contraindicated in patients with: hypersensitivity to the active substance or to any of the excipients listed in section 6.1 acute heart failure or during episodes of heart failure decompensation ...

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 a special titration phase (see section 4.2). Applies to all ...

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. disopyramide, quinidine, 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, β-adrenoceptor blockers reduce placental perfusion, which has been associated ...

Effects on ability to drive and use machines

In a study of coronary heart disease patients, bisoprolol did not impair driving performance. However, depending on the individual patients response to treatment, the ability to drive a vehicle or to use ...

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). ...

Overdose

Symptoms With overdose (e.g. daily dose of 15 mg instead of 7.5 mg) third degree AV-block, bradycardia, and dizziness have been reported. In general, the most common signs expected with overdose of a beta-blocker ...

Pharmacodynamic properties

Pharmacotherapeutic group: Beta blocking agents, selective ATC Code: C07AB07 Chronic heart failure Mechanism of action Bisoprolol is a potent, highly beta1-selective adrenoreceptor blocking ...

Pharmacokinetic properties

Absorption 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 ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity or carcinogenic potential, toxicity to reproduction and ...

List of excipients

Strength Tablet Film-coat 1.25 mg tablet only: Cellulose microcrystalline Butylhydroxyanisole Isopropyl alcohol Colloidal anhydrous silica Magnesium stearate Sodium lauril sulfate ...

Incompatibilities

Not applicable.

Shelf life

Blister: 2 years. Bottle: 2 years.

Special precautions for storage

Blister: Store below 30°C. Bottle: This medicinal product does not require any special storage conditions.

Nature and contents of container

PVC/Al blister packs. Blister pack comprises of clear transparent PVC film with backing of aluminium foil coated with heat seal lacquer containing 10, 20, 28, 30, 50, 56, 84, 90, 98 and 100 film-coated ...

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Marketing authorization holder

Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization number(s)

PL 04569/1254 PL 04569/1255 PL 04569/1256 PL 04569/1257 PL 04569/1258 PL 04569/1259

Date of first authorization / renewal of the authorization

10/10/2015

Date of revision of the text

12/2021

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