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ViiV Healthcare UK Ltd
Stockley Park West, Uxbridge, Middlesex,, UB11 1BT, UK
Telephone: +44 (0)800 221 441
Fax: +44 (0)208 990 4328

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: 09/06/2011
SPC Combivir 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 09/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   02-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 updated to add the information that lamivudine should not be taken with drugs containing lamivudine or emtricitabine

Section 4.5 updated to delete the information as regards the co-administration of lamivudine with ganciclovir or foscarnet

Section 4.6 updated to give a consistent message as regards the clinical experience gained on the use of lamivudine during pregnancy and harmonise the fertility, pregnancy and lactation statement between EPIVIR (revised wording recently adopted by the CHMP) and KIVEXA and TRIZIVIR (and COMBIVIR)

Clarifications in section 5.3.
Section 10 updated date of revision
Updated on 08/12/2010 and displayed until 09/06/2011
Reasons for adding or updating:
  • 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:   03-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 - Addition of Angiodema as rare
Section 10 - EMEA to EMA and date of revision
Updated on 02/08/2010 and displayed until 08/12/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 7 - MAH transfer to ViiV – address updates
Section 10 - Date updated
Updated on 25/09/2008 and displayed until 02/08/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   16-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Tablets may be crushed

Section 5.2 - Paragraph on crushed tablets

Section 10 - Date of approval
Updated on 06/12/2007 and displayed until 25/09/2008
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 - Patients co-infected with hepatitis C virus: Comcomitant use of ribavirin with zidovudine is not recommended due to an increased risk of anaemia

Section 4.4 - The concomitant use of stavudine with zidovudine should be avoided

Section 4.5 - Update to interaction information (probenecid, rifampicin, atovaquone, Valproic acid, methadone, stavudine)

Section 4.5 - Addition of info regarding clarithromycin, fluconazole and stavudine interactions, as well as ribivarin (increased risk of anaemia).
Updated on 26/11/2007 and displayed until 06/12/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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:   11/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 3: Update to tablet description
Section 4.1: Indication now includes paediatrics
Section 4.2:  Dosing recommendations by body weight to cover paediatrics with the scored tablet
Section 5.2:  Pharmacokinetics in children updated
Section 10: Revision date amended
Updated on 21/09/2007 and displayed until 26/11/2007
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:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

updatesection 5.1 (Pharmacodynamics) of the SPC regarding M184V resistance and lamivudine, with the addition of the following wording:
"In vitro data tend to suggest that the continuation of lamivudine in anti-retroviral regimen despite the development of M184V might provide residual anti-retroviral activity (likely through impaired viral fitness). The clinical relevance of these findings is not established. Indeed, the available clinical data are very limited and preclude any reliable conclusion in the field. In any case, initiation of susceptible NRTIs should always be preferred to maintenance of lamivudine therapy. Therefore, maintaining lamivudine therapy despite emergence of M184V mutation should only be considered in cases where no other active NRTIs are available."
 
Section 10: Update to 3rd September 2007
Updated on 13/02/2007 and displayed until 21/09/2007
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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:   01/2007
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 14/01/2005 and displayed until 13/02/2007
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 04/06/2004 and displayed until 14/01/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 18/03/2004 and displayed until 04/06/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 15/03/2004 and displayed until 18/03/2004
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 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
Updated on 24/02/2004 and displayed until 15/03/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 09/02/2004 and displayed until 24/02/2004
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
Updated on 08/11/2002 and displayed until 09/02/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 22/10/2002 and displayed until 08/11/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 17/10/2002 and displayed until 22/10/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 21/09/2001 and displayed until 17/10/2002
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
Updated on 03/08/2001 and displayed until 21/09/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 18/08/2000 and displayed until 03/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 18/08/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  lamivudine
  zidovudine