EMCOR Film-coated tablet

Product name and form

Emcor 5 mg film-coated tablets.

Emcor 10 mg film-coated tablets.

Pharmaceutical Form

Emcor 5 mg:

Film-coated tablet.

Yellowish-white, heart shaped, scored and film-coated tablet.

Emcor 10 mg:

Film-coated tablet.

Pale orange-light orange, heart shaped, scored and film-coated tablet.

The tablet can be divided into equal halves.

Qualitative and quantitative composition

Emcor 5 mg: Each tablet contains 5 mg Bisoprolol fumarate (equivalent to 4.2mg bisoprolol).

Emcor 10 mg: Each tablet contains 10 mg Bisoprolol fumarate (equivalent to 8.4mg bisoprolol).

For the full list of excipients, see section 6.1.

List of Excipients

Silica colloidal anhydrous
Magnesium stearate
Crospovidone
Microcrystalline cellulose
Maize starch
Calcium hydrogen phosphate anhydrous

Coating:

Iron oxide red E172 (10mg only)
Iron oxide yellow E172
Dimeticone
Macrogol 400
Titanium dioxide E171
Hypromellose

Pack sizes and marketing

Cartons containing aluminium/PVC blister packs of 4, 14 or 28 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Merck Serono (Ireland) Limited, 4045 Kingswood Road, Citywest Business Campus, Dublin 24, Ireland

Marketing authorization dates and numbers

PA 2286/2/1
PA 2286/2/2

Date of First Authorisation: 30th June, 1988
Date of latest renewal 30th June, 2003

Drugs

Drug
Countries
Netherlands