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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.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: 01/12/2011
SPC Phenergan 25 mg 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 01/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • 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. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • 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 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   08-Sep-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1- TM removed
Section 2- lactose content added and clarification of active ingredient content
Section 3- "tablet" added
Section 4.2- "(see section 4.3)" inserted after sentence about use in under 2's.
Section 4.6 - "fertility" inserted into title
Section 5.1 - "phenothiazine derivative" inserted
Section 6.1 - Lactose "monohydrate" and list restructured
Section 6.2 - "none stated" changed to "not applicable"
Section 6.3 - 60months changed to 5 years
section 6.4 - "store in original container" added
Section 6.6- "none stated" replaced with "no special requirements"
Section 9 -  date of first authorisation added
Updated on 18/09/2007 and displayed until 01/12/2011
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 4.8 - Undesirable Effects
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   03/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 (Contrainidications): Information regarding use in children has been updated:
         'Promethazine is contraindicated for use in children less than two years of age because of the potential 
       for fatal respiratory depression.'
 
Section 4.4 (Special warnings and precautions for use): The following statement has been added:
 

           'Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-
            galactose malabsorption should not take this medicine.'
 
Section 4.8 (Undesirable effects): Urticaria, rash and pruritis added.
 
Section 7 (Marketing Authorisation Holder): change in MA Holder's details
Updated on 17/08/2006 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 

9          DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

                17 July 2006 (New  date)

10        DATE OF (PARTIAL) REVISION OF THE TEXT

               July 2006 (New date)
Updated on 07/06/2006 and displayed until 17/08/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   1/5/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 Addition of following text:
 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
 
Section 6.1 Definition of ingredients of Opaspray.
 
 
Updated on 06/06/2006 and displayed until 07/06/2006
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:   1/4/05
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Previous version of SPC included Phenergan Nightime which is now discontinued.
Updated on 27/09/2005 and displayed until 06/06/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/09/2004 and displayed until 27/09/2005
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  promethazine hydrochloride