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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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: 19/07/2010
SPC Viagra 25mg, 50mg, 100mg

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 19/07/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Addition of

Severe Cutaneous Adverse Reactions (SCAR) to Section 4.8

 

 
Updated on 23/02/2009 and displayed until 19/07/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   29-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 10 – date of revision updated
Updated on 18/09/2008 and displayed until 23/02/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   01-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2: Administrative change

Section 3: Administrative change

Section 4.2: Update to use in children to include adolescents

Section 4.8: Reformatted. Somnolence, hypoaesthesia, atrial fibrillation, vertigo, tinnitus, nausea, dry mouth, lacrimation disorders added.
Updated on 26/03/2008 and displayed until 18/09/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   03/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

4.8 inclusion of updated post-marketing surveillance information regarding hearing loss/sudden deafness.
Updated on 27/11/2007 and displayed until 26/03/2008
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

6.5 – details of 1 pack size removed

8.0 – details of 1 pack size removed
Updated on 23/10/2007 and displayed until 27/11/2007
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

8.  Marketing authorisation numbers for the 2 pack size added
Updated on 11/07/2006 and displayed until 23/10/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to 4.3   Contra-indications
Updated on 29/11/2005 and displayed until 11/07/2006
Reasons for adding or updating:
  • 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
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 10 (date of (partial) revision of the text
Updated on 10/05/2005 and displayed until 29/11/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 01/03/2005 and displayed until 10/05/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 07/09/2004 and displayed until 01/03/2005
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 21/06/2004 and displayed until 07/09/2004
Reasons for adding or updating:
  • 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
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/11/2003 and displayed until 21/06/2004
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.3 - Contra-indications
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 01/09/2003 and displayed until 20/11/2003
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 6. 5 - Nature and Contents of Container
  • Correction of spelling/typing errors
Updated on 29/05/2002 and displayed until 01/09/2003
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/12/2001 and displayed until 29/05/2002
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 (date of (partial) revision of the text
Updated on 13/09/2001 and displayed until 17/12/2001
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 20/08/2001 and displayed until 13/09/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 16/10/2000 and displayed until 20/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 09/03/2000 and displayed until 16/10/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 04/02/2000 and displayed until 09/03/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 04/02/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  sildenafil citrate