ZYBAN Prolonged release tablet

Active ingredients: Bupropion

Product name and form

Zyban 150 mg prolonged release tablets.

Pharmaceutical Form

Prolonged release tablet.

White, film-coated, biconvex, round tablet printed on one side with GX CH7 and plain on the other side.

Qualitative and quantitative composition

Each tablet contains bupropion hydrochloride 150 mg.

For the full list of excipients, see section 6.1.

Active Ingredient

Bupropion is a selective inhibitor of the neuronal re-uptake of catecholamines (noradrenaline and dopamine) with minimal effect on the re-uptake of indolamines (serotonin) and does not inhibit either monoamine oxidase. The mechanism by which bupropion enhances the ability of patients to abstain from smoking is unknown. However, it is presumed that this action is mediated by noradrenergic and/or dopaminergic mechanisms.

List of Excipients

Tablet core:

Microcrystalline cellulose
Cysteine hydrochloride monohydrate
Magnesium stearate

Film coat:

Macrogol 400
Titanium dioxide (E171)
Carnauba wax

Printing ink:

Iron oxide black (E172)

Pack sizes and marketing

Cartons containing cold form foil/foil child-resistant blister packs (PA-Alu-PVC/Paper-Alu).

30, 40, 50, 60 or 100 tablets are supplied in each pack. Each blister strip contains 10 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Glaxo Wellcome UK Ltd. trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT, UK

Marketing authorization dates and numbers

PL 10949/0340

7 June 2000/1 Dec 2004


Australia, Brazil, Canada, France, Ireland, Netherlands, New Zealand, Poland, United Kingdom, South Africa