SPC, UK: ZYBAN Prolonged release tablets (2018)

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.

List of excipients

Tablet core:

Microcrystalline cellulose
Hypromellose
Cysteine hydrochloride monohydrate
Magnesium stearate

Film coat:

Hypromellose
Macrogol 400
Titanium dioxide (E171)
Carnauba wax

Printing ink:

Iron oxide black (E172)
Hypromellose

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
Authorization dates

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

7 June 2000/1 Dec 2004

Marketing authorization number:

PL 10949/0340