CELIPROLOL HYDROCHLORIDE Film-coated tablet Ref.[7778] Active ingredients: Celiprolol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Ranbaxy (UK) Limited, 5th floor, Hyde Park, Hayes 3, 11 Millington Road, Hayes, UB3 4AZ, United Kingdom

Product name and form

Celiprolol hydrochloride 400 mg film-coated Tablets.

Pharmaceutical Form

Film-coated tablet.

White coloured, capsule shaped, biconvex film coated tablets, debossed with ‘400’ on one side of the breakline and a deep breakline on the other side.

The tablet can be divided into equal doses.

Qualitative and quantitative composition

Each tablet contains 400 mg celiprolol hydrochloride.

Each tablet contains 3.6mg lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Celiprolol

Celiprolol is a vasoactive beta-l selective adrenoceptor antagonist with partial beta-2 agonist activity indicated in mild to moderate hypertension. The beta-2 agonist activity is thought to account for its mild vasodilating properties. It lowers blood pressure in hypertensive patients at rest and on exercise.

List of Excipients

Microcrystalline cellulose
Mannitol
Croscarmellose sodium
Colloidal anhydrous silica
Magnesium stearate

Film coating material:

Hypromellose
Titanium dioxide (E171)
Macrogol 400
Lactose monohydrate

Pack sizes and marketing

Blister strips comprising of white opaque PVC film with a backing of aluminium foil coated with heat seal lacquer.

Pack of 10, 20, 28, 30, 50, 56 and 100 tablets.

Marketing authorization holder

Ranbaxy (UK) Limited, 5th floor, Hyde Park, Hayes 3, 11 Millington Road, Hayes, UB3 4AZ, United Kingdom

Marketing authorization dates and numbers

PL 14894/0046

27/06/2007

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