CARDICOR Film-coated tablet Ref.[49933] Active ingredients: Bisoprolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Merck Serono Ltd, 5 New Square, Bedfont Lakes Business Park, Feltham, Middlesex, TW14 8HA, UK

Product name and form

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 tablets.

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, scored and film-coated tablets.

Cardicor 5 mg: yellowish white, heart-shaped, scored and film-coated tablets.

Cardicor 7.5 mg: pale yellow, heart-shaped, scored and film-coated tablets.

Cardicor 10 mg: pale orange – light orange, heart-shaped, scored and film-coated tablets.

The scored tablets can be divided into two equal doses.

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 bisoprolol fumarate.

Cardicor 5 mg: Each tablet contains 5 mg bisoprolol fumarate.

Cardicor 7.5 mg: Each tablet contains 7.5 mg bisoprolol fumarate.

Cardicor 10 mg: Each tablet contains 10 mg bisoprolol fumarate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Bisoprolol

Bisoprolol is a potent highly beta1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and without relevant membrane stabilising activity.

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.

Film coating: Dimethicone, talc, macrogol 400, titanium dioxide (E171), hypromellose.

Cardicor 2.5 mg

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

Film coating: Dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

Cardicor 3.75 mg

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

Film coating: Iron oxide yellow (E172), dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

Cardicor 5 mg

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

Film coating: Iron oxide yellow (E172), dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

Cardicor 7.5 mg

Tablet core: Silica, colloidal anhydrous, magnesium stearate, crospovidone, microcrystalline cellulose, maize starch, calcium hydrogen phosphate, anhydrous.

Film coating: Iron oxide yellow (E172), dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

Cardicor 10 mg

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

Film coating: Iron oxide red (E172), iron oxide yellow (E172), dimethicone, macrogol 400, titanium dioxide (E171), hypromellose.

Pack sizes and marketing

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.

Pack sizes: 20, 28, 30, 50, 56, 60, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 11648/0071-76

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

Drugs

Drug Countries
CARDICOR Ireland, Italy, United Kingdom, South Africa

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