NEBILET Tablet Ref.[7007] Active ingredients: Nebivolol

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg

Product name and form

NEBILET 5 mg tablets.

Pharmaceutical Form
Tablet. White, round, cross-scored tablet. The tablet can be divided in equal quarters.

Qualitative and quantitative composition

Each Nebilet tablet contains 5 mg of nebivolol (as nebivolol hydrochloride): 2.5 mg of SRRR-nebivolol (or d-nebivolol) and 2.5 mg of RSSS-nebivolol (or l-nebivolol).

Excipient with known effect: each tablet contains 141.75 mg of lactose monohydrate (see section 4.4 and 6.1).

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Nebivolol	Nebivolol is a racemate of two enantiomers, SRRR-nebivolol (or d-nebivolol) and RSSS-nebivolol (or l-nebivolol). It is a competitive and selective beta-receptor antagonist and it has mild vasodilating properties due to an interaction with the L-arginine/nitric oxide pathway.

List of Excipients
Polysorbate 80 (E433) Hypromellose (E464) Lactose monohydrate Maize starch Croscarmellose sodium (E468) Microcrystalline cellulose (E460) Silica, colloidal anhydrous (E551) Magnesium stearate (E572)

Pack sizes and marketing

Tablets are provided in blister packs (PVC/aluminium blister).

Pack sizes of 7, 14, 28, 30, 50, 56, 90, 100, 500 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg

Marketing authorization dates and numbers

PL 16239/0013

Date of first authorisation: 4^th January 1999
Date of latest renewal: 18 October 2010

Drugs

Drug	Countries
NEBILET	Australia, Brazil, Germany, Ecuador, Estonia, Hong Kong, Croatia, Ireland, Lithuania, Malta, Netherlands, Poland, Romania, Singapore, Tunisia, United Kingdom, South Africa

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