CARDICOR Film-coated tablet (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Cardicor 1.25 mg film-coated tablets. Cardicor 2.5 mg film-coated tablets. Cardicor 3.75 mg film-coated tablets. Cardicor 5 mg film-coated tablets. Cardicor 7.5 mg film-coated tablets. Cardicor 10 mg film-coated ...

2. Qualitative and quantitative composition

Cardicor 1.25 mg: Each tablet contains 1.25 mg bisoprolol fumarate. Cardicor 2.5 mg: Each tablet contains 2.5 mg bisoprolol fumarate. Cardicor 3.75 mg: Each tablet contains 3.75 mg ...

3. Pharmaceutical form

Film-coated tablet. Cardicor 1.25 mg: white, round film-coated tablets. Cardicor 2.5 mg: white, heart-shaped, scored and film-coated tablets. Cardicor 3.75 mg: off-white, heart-shaped, ...

4.1. Therapeutic indications

Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides (for additional information see ...

4.2. Posology and method of administration

Standard treatment of CHF consists of an ACE inhibitor (or an angiotensin receptor blocker in case of intolerance to ACE inhibitors), a beta-blocker, diuretics, and when appropriate cardiac glycosides. ...

4.3. 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 ...

4.4. Special warnings and precautions for use

The treatment of stable chronic heart failure with bisoprolol has to be initiated with a special titration phase. Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol ...

4.5. Interaction with other medicinal products and other forms of interaction

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 ...

4.6. 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 ...

4.7. 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 ...

4.8. 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), ...

4.9. 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 overdosage of a ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Beta blocking agents, selective ATC Code: C07AB07 Mechanism of action Bisoprolol is a highly beta1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating ...

5.2. Pharmacokinetic properties

Absorption Bisoprolol is absorbed and has a biological availability of about 90% after oral administration. Distribution The distribution volume is 3.5 l/kg. The plasma protein binding of bisoprolol is ...

5.3. 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 ...

6.1. List of excipients

Cardicor 1.25 mg Tablet core: Silica, colloidal anhydrous; magnesium stearate, crospovidone, pregelatinised maize starch, maize starch, microcrystalline cellulose, calcium hydrogen phosphate, anhydrous. ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

Shelf life for PVC/Alu blister Cardicor 1.25 mg, 2.5 mg and 3.75 mg: 3 years. Cardicor 5 mg, 7.5 mg and 10 mg: 5 years. Shelf life for Alu/Alu blister Cardicor 1.25 mg, 2.5 mg, 3.75 mg, ...

6.4. Special precautions for storage

Storage conditions for PVC/Alu blister Cardicor 1.25 mg, 2.5 mg and 3.75 mg: Do not store above 25°C. Cardicor 5 mg, 7.5 mg and 10 mg: Do not store above 30°C. Storage conditions for Alu/Alu ...

6.5. Nature and contents of container

The container is a blister, which is made of a polyvinylchloride base film and an aluminium cover foil. The container is a blister, which is made of an aluminium forming foil and an aluminium sealing foil. ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK

8. Marketing authorization number(s)

PL 11648/0071-76

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 4 June 2004 Date of latest renewal: 22 December 2009

10. Date of revision of the text

06 November 2020

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