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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: 11/05/2011
SPC Relenza 5mg/dose inhalation powder.

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 11/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.4  Updated of inhalation powder administred by nebulisation
4.8 Updated with information on common adverse reactions
4.9 Updated with information on doses
10. Updated with new revision date
Updated on 30/07/2010 and displayed until 11/05/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • 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:   30-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
1. Removal of Black Triangle (should already have been updated)
4.8  Skin and subcutaneous tissue disorders:

Very rare:    rash, urticaria

Not known:   Severe skin reactions including Erythema Multiforme, Stevens-Johnson syndrome and Toxic epidermal necrolysis
10. June 2010
Updated on 14/05/2010 and displayed until 30/07/2010
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   02-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of Black Triangle
Updated on 21/10/2009 and displayed until 14/05/2010
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
section 9 - 02/10/2008
section 10 - 02/10/2008
Updated on 26/05/2009 and displayed until 21/10/2009
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   20-May-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Section 6.3 - 7 years

 

Section 10 - 20th May 2009

 
Updated on 10/11/2008 and displayed until 26/05/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Neuropsychiatric events have been reported during administration of Relenza in patients with influenza, especially in children and adolescents. Therefore, patients should be closely monitored for behavioural changes and the benefits and risks of continuing treatment should be carefully evaluated for each patient (see section 4.8).

Section 4.8 - Psychiatric and nervous system disorders:

Convulsions and psychiatric events such as depressed level of consciousness, abnormal behaviour, hallucinations and delirium have been reported during Relenza administration in patients with influenza. The symptoms were mainly reported in children and adolescents. Convulsions and psychiatric symptoms have also been reported in patients with influenza not taking Relenza.

Section 10 - 1st Oct 2008
Updated on 09/01/2008 and displayed until 10/11/2008
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 2: Excipients up
Section 3: Inclusion of powder description
Section 4.2: Inhaled drugs/Reference to section 4.4 moved to top of section
Section 4.3: Hypersensitivity statement updated
Section 4.4: Lactose statement
Section 4.7: Section updated
Section 4.8: Statement added re. undesirable effects presented in decreasing seriousness
Section 5.1: Pharmacotherapeutic group added. Median time to alleviate symptoms in elderly/children moved further up in section
Section 6.6: Section heading updated
Section 10: Date of approval added
 
Updated on 27/09/2006 and displayed until 09/01/2008
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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:   08/2006
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 11/11/2005 and displayed until 27/09/2006
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 18/02/2005 and displayed until 11/11/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • 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
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/01/2004 and displayed until 18/02/2005
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 6.1 - List of Excipients
Updated on 04/06/2003 and displayed until 28/01/2004
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 06/08/2002 and displayed until 04/06/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 30/07/2002 and displayed until 06/08/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 23/08/2001 and displayed until 30/07/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 10/07/2001 and displayed until 23/08/2001
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5 - Pharmacological Properties
Updated on 22/03/2001 and displayed until 10/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 21/07/2000 and displayed until 22/03/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 12/04/2000 and displayed until 21/07/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  zanamivir