SPC, UK: BISOPROLOL Film-coated tablets (2019)

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.

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
Authorization dates

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

21/12/2011

Marketing authorization number:

PL 20075/0317