BISOCOR Tablet Ref.[49832] Active ingredients: Bisoprolol

Source: Health Products Regulatory Authority (IE)  Revision Year: 2019  Publisher: Unichem Laboratories Ltd, Studio 8B, Ard Gaoithe Commercial Centre, Ard Gaoithe Business Park, Cashel Road, Clonmel, Co Tipperary, Ireland

Product name and form

Bisocor 5 mg Tablets.

Pharmaceutical Form

Tablet.

The tablets are pale yellow mottled in colour, round and convex with the following identification markings: BI centrally above a break-line with 5 below.

The tablets can be divided into equal halves.

Qualitative and quantitative composition

Each tablet contains 5 mg of bisoprolol fumarate.

Excipient with known effect: Lactose Monohydrate 136 mg.

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

Lactose monohydrate
Cellulose, microcrystalline E460
Magnesium stearate E572
Crospovidone E1201
Yellow PB 22812 (lactose monohydrate and iron oxide yellow (E172))

Pack sizes and marketing

Bisocor 5 mg tablets are presented in:

Blisters comprising of PVC/PVdC/aluminium foil, contained within a printed carton box. Each carton will contain either; 10, 20, 28, 30, 50, 56, 60, or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Unichem Laboratories Ltd, Studio 8B, Ard Gaoithe Commercial Centre, Ard Gaoithe Business Park, Cashel Road, Clonmel, Co Tipperary, Ireland

Marketing authorization dates and numbers

PA22654/003/001

Date of first authorisation: 29 June 2001
Date of last renewal: 05 September 2010

Drugs

Drug Countries
BISOCOR Albania, Austria, Ireland, Singapore, Tunisia

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