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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: 15/06/2011
SPC Valtrex Tablets 500mg

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 15/06/2011 and displayed until Current
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:   28-Apr-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
4.8 - addition of ‘delerium’ and ‘haematuria’
10 - updated date of revision
Updated on 13/04/2011 and displayed until 15/06/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5 - addition of pack size not marketed in the UK
Section 10 - updated date of revision
Updated on 19/08/2010 and displayed until 13/04/2011
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological Properties
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   13-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
All sections of SPC updated due to harmonisation of SPC
Updated on 17/10/2008 and displayed until 19/08/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   17-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.6 - typo correction

Section 4.8 - Very rare:  renal pain.
                                Renal pain may be associated with renal failure.
Updated on 02/09/2008 and displayed until 17/10/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.9 - Overdose
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.2 - Updated Dosage in Renal impairment

Section 4.4 - Updated Use in patients with Renal Impairment - increased risk of developing neurological side effects

Section 4.8 - Minor update Psychiatric and nervous system disorders

Section 4.9 - Updated symptoms and signs of overdose

Section 10 - Approval date
Updated on 26/01/2006 and displayed until 02/09/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 20/01/2006 and displayed until 26/01/2006
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 17/01/2006 and displayed until 20/01/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 13/12/2005 and displayed until 17/01/2006
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
Updated on 02/12/2004 and displayed until 13/12/2005
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 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 27/01/2004 and displayed until 02/12/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 17/12/2003 and displayed until 27/01/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 22/04/2003 and displayed until 17/12/2003
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Updated on 27/03/2003 and displayed until 22/04/2003
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 09/01/2003 and displayed until 27/03/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 08/01/2003 and displayed until 09/01/2003
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Updated on 19/12/2002 and displayed until 08/01/2003
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
Updated on 25/09/2002 and displayed until 19/12/2002
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 11/09/2002 and displayed until 25/09/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
Updated on 20/08/2001 and displayed until 11/09/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 15/05/2000 and displayed until 20/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 15/05/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  valaciclovir hydrochloride