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GlaxoSmithKline UK
Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328
Medical Information e-mail: customercontactuk@gsk.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 22/03/2011
SPC Zyban 150 mg prolonged release film-coated tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 22/03/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.3 Update warning to not administer Zyban with any other medicinal product containing bupropion in order to avoid overdosage.
4.4 Addition of warning avoid using Zyban when being treated with tamoxifen.
4.5 Addition of warning that tamoxifen may have reduced efficacy if administered concomitantly with Zyban.
10. Updated with new date of revisiion of text
Updated on 10/01/2011 and displayed until 22/03/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.5    (interaction with other medicinal products and other forms of interaction) of the SPC to include reference to efavirenz (HIV-1 non-nucleoside reverse transcriptase inhibitor).

10.    5 November 2010
Updated on 11/03/2010 and displayed until 10/01/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Wording changed for renal function in elderly patients

Section 4.6 -  Description related to breast feeding amended

Section 4.8 - Minor changes to frequency data

Section 10 - Date change to 1st December 2009.
Updated on 14/01/2009 and displayed until 11/03/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   06-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - For a full list of excipients, see section 6.1.

Section 4.2 - Zyban tablets should be swallowed whole. The tablets should and not be crushed or chewed as this may lead to an increased risk of adverse effects including seizures.

Section 4.4 - Renally-impaired - Bupropion is mainly excreted into urine as its metabolites. Therefore 150 mg once a day is the recommended dose in patients with renal impairment, as bupropion and its the active metabolites may accumulate in such patients to a greater extent than usual (see sections 4.2 and 5.2). The patient should be closely monitored for possible undesirable effects that could indicate high drug or metabolite levels.

Section 4.5 - In a series of studies in healthy volunteers, ritonavir (100 mg twice daily or 600 mg twice daily) or ritonavir 100 mg plus lopinavir 400 mg (Kaletra®) twice daily reduced the exposure of bupropion and its major metabolites in a dose dependent manor by approximately 20 to 80% (see section 5.2). This effect is thought to be due to the induction of bupropion metabolism. Patients receiving ritonavir may need increased doses of bupropion but the maximum recommended dose of bupropion should not be exceeded. Nicotine, administered transdermally by patches, did not affect the pharmacokinetics of bupropion and its metabolites.

Section 5.2 - Special Patient Groups: Patients with renal impairment The elimination of bupropion and its the active major metabolites of bupropion may be reduced in patients with impaired renal function. Limited data in patients with end-stage renal failure or moderately to severely impaired renal function indicate that exposure to bupropion and/or its metabolites was increased

Section 10 - 6 January 2009
Updated on 20/10/2008 and displayed until 14/01/2009
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   18-Jul-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.9 - Amendment to text on treatment of overdose including removal of the recommendation to use gastric lavage in cases of overdose.
Updated on 24/06/2008 and displayed until 20/10/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   25-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - 

Neuropsychiatry

Zyban is a centrally-acting noradrenaline/dopamine reuptake inhibitor and as such the pharmacology resembles that of some antidepressants. Neuropsychiatric reactions have been reported (see section 4.8 Undesirable Effects). In particular, psychotic and manic symptomatology have been reported mainly in patients with a known history of psychiatric illness.

Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation and behaviour (including suicide attempt)suicide attempt, has been reported in patients undergoing a smoking cessation attempt. These symptoms have also been reported during Zyban treatment, and generally occurred early during the treatment course.

Bupropion is indicated for the treatment of depression in some countries. A meta-analysis of placebo controlled clinical trials of antidepressant drugs in adults with major depressive disorder and other psychiatric disorders showed an increased risk of suicidal thinking and behaviour associated with antidepressant use compared to placebo in patients less than 25 years old.

Section 4.8 - 

Not known Suicidal ideation and suicidal behaviour***

***Cases of suicidal ideation and suicidal behaviour have been reported during bupropion therapy (see section 4.4).

Section 10 - 25.4.2008
Updated on 07/05/2008 and displayed until 24/06/2008
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Feb-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.1 Pharmacotherapeutic group: ("drugs used in nicotine dependence" - Deleted). Other antidepressants, ATC code: ("N07B A02" - Deleted) N06 AX12.
Updated on 30/10/2006 and displayed until 07/05/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

For further information, please contact GlaxoSmithKline on +44 (0)800 221 441
Updated on 09/02/2006 and displayed until 30/10/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 27/01/2006 and displayed until 09/02/2006
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 24/01/2006 and displayed until 27/01/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 16/01/2006 and displayed until 24/01/2006
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 04/08/2005 and displayed until 16/01/2006
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 16/06/2005 and displayed until 04/08/2005
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.9 - Overdose
Updated on 25/09/2003 and displayed until 16/06/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 10/03/2003 and displayed until 25/09/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 16/12/2002 and displayed until 10/03/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 02/09/2002 and displayed until 16/12/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 17/06/2002 and displayed until 02/09/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
Updated on 17/04/2002 and displayed until 17/06/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 05/04/2002 and displayed until 17/04/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 10/01/2002 and displayed until 05/04/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 18/12/2001 and displayed until 10/01/2002
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/12/2001 and displayed until 18/12/2001
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 25/07/2001 and displayed until 17/12/2001
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 22/03/2001 and displayed until 25/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 18/07/2000 and displayed until 22/03/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  bupropion hydrochloride