SPC, UK: Emcor, Emcor LS (2012)

Product Name and Form

Emcor LS 5 mg film-coated tablets.

Emcor 10 mg film coated tablets.

Pharmaceutical form

5mg Tablet: Film-coated tablet.

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

10mg Tablet: Film-coated tablet.

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

Qualitative and Quantitative Composition

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

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

For excipients, see section 6.1.

List of excipients

Tablet core:

Silica, colloidal anhydrous
Magnesium stearate
Crospovidone
Cellulose, microcrystalline
Maize starch
Calcium hydrogen phosphate, anhydrous

Film coating:

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

Pack sizes and Marketing

Cartons containing blister packs of 4, 14 or 28 tablets.

Marketing authorization holder
Authorization dates

Merck Serono Ltd
Bedfont Cross, Stanwell Road
Feltham, Middlesex
TW14 8NX
UK

27 July 2004

Marketing authorization number:

PL 11648/0069

PL 11648/0070