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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 10mg 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 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and Lactation
  • 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. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   17-Oct-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC updated in line with the QRD template and European SPC guidelines.
Section 1: TM symbol removed.
Section 2: Amount of Lactose Monohydrate added.
Section 3: Film coated tabled added.
Section 4.6: Section title updated.
Section 5.1: Phenothiazine Derivatives added to first paragraph.
Section 6.1: Excipient list updated.
Section 6.2: None stated replaced by not applicable.
Section 6.6: None stated replaced with no special requirements.
Section 9: Dates corrected.
Updated on 06/01/2009 and displayed until 01/12/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • 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
Date of revision of text on the SPC:   01-Oct-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.1 - addition of the following information;

Pharmacotherapeutic group: Antihistamine for systemic use
ATC code: R06AD02

Section 6.3 - shelf life changed from 60 months to 5 years

Section 6.4 - 'protect from light' removed and 'Store in the original carton in order to protect from light' added

Section 8 - marketing authorisation number changed to 04425/0631

Section 9 - Changed to 3rd October 2008

Section 10 - changed to October 2008
Updated on 18/09/2007 and displayed until 06/01/2009
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:   05/2007
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 2 - qualitative and quantitative composition
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) 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
 

2          QUALITATIVE AND QUANTITATIVE COMPOSITION

             Promethazine hydrochloride BP 10 mg. (Removed BP)
 
 

6.1       List of Excipients

            Lactose BP (Remove BP)
            Maize starch BP (Remove BP)
            Povidone K30 BP (Remove BP)
            Magnesium stearate BP (Remove BP) 
            Polyethylene glycol 200
            Opaspray M-1-4210A (contains E132 and E171) Replaced by (contains Titanium dioxide - E 171, Hypromellose - E464         
            and Indigo carmine aluminium lake FD& C Blue no 2 - E132)
            Hypromellose (Pharmacoat 606) (Hypromellose added)
 
 

10        DATE OF (PARTIAL) REVISION OF THE TEXT

 `           August 2006 (Replaces April 2005)

 
 
Updated on 31/08/2005 and displayed until 17/08/2006
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 31/08/2005
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  promethazine hydrochloride