BISOPROLOL Film-coated tablets

Active ingredients: Bisoprolol

Product name and form

Bisoprolol 5 mg Film-coated Tablet.

Pharmaceutical Form

Film-coated tablet.

White to off white, round, biconvex, film coated tablets, debossed ‘b2’ on one side and break line on other side.

Tablet diameter is approximately 7.2 mm.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each film-coated tablet contains 5 mg Bisoprolol fumarate.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

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

List of Excipients

Core Tablet:

Cellulose microcrystalline
Sodium starch glycolate(Type-A)
Povidone K-30
Silica colloidal anhydrous
Magnesium stearate (E470b)

Coating:

Hypromellose E-15 (E464)
Macrogol 400 (E553)
Titanium dioxide (E171)
Talc

Pack sizes and marketing

PVC/PVDC-Alu Blister or ALU-ALU Blister in Pack sizes of 20, 28, 30, 50, 56, 60, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage house, 319 Pinner road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0317

21/12/2011