NIQUITIN Transdermal patch Ref.[27687] Active ingredients: Nicotine

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Omega Pharma Ltd., 1st Floor, 32 Vauxhall Bridge Road, LONDON, SW1V 2SA, United Kingdom

Product name and form

NiQuitin 7 mg transdermal patches.

Pharmaceutical Form
Transdermal patch. Each patch is rectangular and is comprised of an outer matt pinkish tan-coloured layer, a middle silver layer and an outer clear layer which is removed prior to use.

Qualitative and quantitative composition

Each 7 cm² transdermal patch contains 36 mg nicotine, equivalent to 5.1 mg/cm² of nicotine and delivering 7 mg over 24 hours.

For the 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
Drug Reservoir: Ethylene Vinyl Acetate Copolymer Occlusive Backing: Polyethylene/Aluminium/Polyethylene Terephthalate/Ethylene vinyl acetate Rate Controlling Membrane: Polyethylene Film Contact Adhesive and Protective Layer: Polyisobutylene Adhesive Laminate Printing Ink: FGN-7214 NT20 Brown 465 (Ink)

Pack sizes and marketing

7 or 14 patches in a carton. Each patch is contained in a laminate sachet.

Marketing authorization holder

Omega Pharma Ltd., 1st Floor, 32 Vauxhall Bridge Road, LONDON, SW1V 2SA, United Kingdom

Marketing authorization dates and numbers

PL 02855/0254

22/04/2009

Drugs

Drug	Countries
NIQUITIN	Austria, Brazil, Estonia, Spain, France, Ireland, Lithuania, Mexico, Netherlands, Poland, Tunisia, United Kingdom, South Africa

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