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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: 25/02/2010
SPC Maalox Suspension

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 25/02/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   11-Jan-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

section 4.6: information regarding magnesium in lactation added
section 4.9: information on management of magnesium overdose added
Updated on 20/02/2009 and displayed until 25/02/2010
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
Date of revision of text on the SPC:   01-Jan-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 8: change of product licence number to PL 04425/0378
Section 9: change of date to 23 January 2009
Section 10: change of date to January 2009

 

Updated on 27/11/2008 and displayed until 20/02/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Nov-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In section 6.1, the specifications for all excipients (except peppermint oil and hydrogen peroxide) have been updated to replace the pharmacopoeial references with E-numbers
Updated on 12/09/2007 and displayed until 27/11/2008
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
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   07/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 (Special warnings and Special precautions for use): Warning regarding use in renal impairment and porphyria added
 
Section 4.5 (Interactions with other medicinal products and other forms of interactions): Statement regarding increased levels of aluminium particularly in renally impaired patients.
 
Section 7 (Marketing Authorisation Holder): Change to MA Holder's address
Updated on 31/08/2005 and displayed until 12/09/2007
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 (date of (partial) revision of the text
Updated on 23/08/2001 and displayed until 31/08/2005
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 16/10/2000 and displayed until 23/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 22/09/2000 and displayed until 16/10/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 22/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   aluminium hydroxide gel
   magnesium hydroxide