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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: 24/01/2011
SPC Maalox Plus 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 24/01/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11-Jan-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2        BP removed

Section 3        Description of the tablets has now been included

Section 4.3     Following information has been added; 'patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine'

Section 6.1    Purified water deleted from list of excipients

Section 6.4    Store below 30oC added
Updated on 25/02/2010 and displayed until 24/01/2011
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 in product licence number to PL 04425/0177
Section 9: Change of date to 23 January 2009
Section 10: Change of date to January 2009
Updated on 21/05/2008 and displayed until 20/02/2009
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Jul-2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Pack size has changed from 50 to 40 tablets
Updated on 18/09/2007 and displayed until 21/05/2008
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:
 

'In patients with renal impairment, plasma levels of both aluminium and magnesium increase. In these patients, a long-term exposure to high doses of aluminium and magnesium salts may lead to dementia, microcytic anemia.

 

Aluminum hydroxide may be unsafe in patients with porphyria undergoing hemodialysis.'
 
Section 4.5 (Interactions with other medicinal products and other forms of interactions): Information regarding increased aluminium levels, particularly in renally impaired patients added:
 

'Aluminum hydroxide and citrates may result in increased aluminum levels, especially in patients with renal impairment.'

 
Section 7 (Marketing Authorisation Holder): Chnage to MA Holder's address
Updated on 31/08/2005 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
  • Correction of spelling/typing errors
Updated on 06/08/2004 and displayed until 31/08/2005
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  aluminium hydroxide gel
  simeticone
  magnesium hydroxide