NICORETTE INVISI Transdermal patch Ref.[9897] Active ingredients: Nicotine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: McNeil Products Limited, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Product name and form

Nicorette invisi 10 mg patch / NicAssist Translucent 10 mg Patch.

Pharmaceutical Form

Transdermal patch.

Semi-transparent, beige, imprinted 9 cm² rectangular TTS with rounded corners. Centrally located on a rectangular, aluminized and siliconised release liner.

Qualitative and quantitative composition

‘Each patch is 9 sq.cm, containing nicotine 1.75 mg/sq.cm, releasing a nominal 10 mg of nicotine per 16 hours’.

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

Triglycerides, medium-chain
basic butylated methacrylate copolymer
Polyethylenterephthalate film (PET)

Acrylate Matrix:

Acrylic adhesive solution
Potassium hydroxide
Croscarmellose sodium
Aluminium acetylacetonate

Release Liner:

Polyethylenterephthalate (PET) film single side aluminised, both sides siliconised

Printing Ink Solution:

Blending varnish
Printing ink beige
Printing ink brown

Pack sizes and marketing

Package sizes: 10 mg/16 h 7 and 14 patches.

All pack sizes may not be marketed.

Each patch is packed in a heat-sealed laminate pouch consisting of paper, PET film, aluminium acrylnitrilcopolymer or cyclo olefine copolymer coextrudate.

Marketing authorization holder

McNeil Products Limited, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Marketing authorization dates and numbers

PL 15513/0159

02 December 2008

Drugs

Drug Countries
NICORETTE Austria, Australia, Brazil, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Ireland, Lithuania, Malta, Netherlands, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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