NICOTINELL MINT Compressed lozenge Ref.[6426] Active ingredients: Nicotine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Product name and form

Nicotinell Mint 1 mg compressed lozenges.

Pharmaceutical Form

Compressed lozenge.

White, mint flavoured, round biconvex lozenge.

Qualitative and quantitative composition

Each piece of lozenge contains: Active substance: 1 mg nicotine (corresponding to 3.072 mg nicotine bitartrate dihydrate).

Excipient(s): aspartame (0.01 g), maltitol (0.9 g) and sodium (9.8 mg).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Nicotine

Nicotine, the primary alkaloid in tobacco products and a naturally occurring autonomous substance, is a nicotine receptor agonist in the peripheral and central nervous systems and has pronounced CNS and cardiovascular effects.
List of Excipients

Maltitol (E965)
Sodium carbonate anhydrous
Sodium hydrogen carbonate
Polyacrylate dispersion 30 per cent
Xanthan gum
Colloidal anhydrous silica
Levomenthol
Peppermint oil
Aspartame (E951)
Magnesium stearate

Pack sizes and marketing

12, 36, 72, 96, 144 or 204 lozenges in opaque blisters consisting of aluminium foil and PVC/PE/PVDC/PE/PVC-film.

or

24, 72, 96 or 144 lozenges in polypropylene tube with an attached closure cap and an integrated desiccant sleeve of molecular sieve along the inner wall of the tube. Each tube contains 24 lozenges. Packs may contain 1, 3, 4 or 6 tubes.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Marketing authorization dates and numbers

PL 44673/0118

Date of first authorisation: 20 July 1999

Date of last renewal: 16 December 2008

Drugs

Drug Countries
NICOTINELL Austria, Australia, Brazil, Estonia, Spain, Finland, France, Hong Kong, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Singapore, Tunisia, Turkey, United Kingdom, South Africa
 
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