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Maalox Plus 200mg/175mg/25mg Oral Suspension

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 29/10/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 30/10/2019

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 30 October 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation

Legal category: Supply through pharmacy only

Updated on 29 October 2019 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation

Legal category: Supply through pharmacy only

Updated on 29 October 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 8 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 8 December 2017 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.5 added:-

Urine alkalinisation secondary to administration of magnesium hydroxide may modify excretion of some drugs; thus, increased excretion of salicylates has been seen.

Section 4.8 amendments:-

Immune system disorders -  amended:-

 Frequency unknown to Not known

Gastrointestinal disorders – added:-

Not known: abdominal pain

 

Metabolism and nutrition disorders

Added:- Very rare: hypermagnesemia including observations after prolonged administration to patients with renal impairment.

Amended:- from Frequency unknown to Not known:

 Removed:- hypermagnesemia,

Updated on 5 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 5 December 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 18 August 2015 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.4: Storage conditions changed to 'Store below 30°C' and an in-use storage included 'The product should be used within 6 months of first opening the bottle.'

Updated on 17 August 2015 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 28 April 2015 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Changes relate to transfer of manufacture to a new site

Updated on 24 April 2015 PIL

Reasons for updating

  • Addition of manufacturer
  • Change to product name

Updated on 13 April 2015 SmPC

Reasons for updating

  • SPC re-instated

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Corrected SmPC re-instated

Updated on 17 September 2014 PIL

Reasons for updating

  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects
  • Change to further information section

Updated on 4 September 2014 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Type 1B b.II.e.1.a.2 To change the immediate package of the drug product

Updated on 28 August 2014 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.3 changed from allergic to hypersensitive.
Section 4.4 information included on intestinal obstruction and ileus in patients at higher risk such as those with renal impairment and information included on aluminium hydroxide not being well absorbed by the gastrointestinal tract.
Section 4.5 updated to include cefdinir and cefpodoxime.  New paragraph on caution when concomitantly used with polystyrene sulfonate.
Section 4.6 updated to include 'Because of the limited maternal absorbtion when used as recommended, alumiunium hydroxide and magnesium sales combinations are considered as compatible with lactation.'
Section 4.8 updated to include immune system disorders and metabolism and nutrition disorders. PV Legislation wording included.
Section 4.9 new paragraphs on Signs and Symptoms and Management.

Updated on 17 January 2013 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 7 May 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Change to product name

Updated on 6 May 2010 PIL

Reasons for updating

  • Change of trade or active ingredient name

Updated on 7 September 2009 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 2 September 2009 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update typographical errors and addtion of excipient warning.

Updated on 10 October 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 8 October 2008 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through pharmacy only

Updated on 9 August 2007 SmPC

Reasons for 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

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update section 4.4 - warnings
section 4.5 - interactions

Updated on 7 November 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Update
Section 7 - Marketing Authorisation Holder changed to sanofi-aventis Ireland Ltd.

Updated on 19 October 2006 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 27 July 2006 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 17 May 2005 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 16 February 2005 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 16 June 2003 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Legal category: Supply through pharmacy only

Updated on 16 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only