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Phospho-soda 24.4g / 10.8g oral solution

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/01/17

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Summary of Product Characteristics last updated on medicines.ie: 30/5/2016
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Recordati Ireland Limited

Recordati Ireland Limited

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Medicine Name Phospho-soda 24.4g / 10.8g oral solution Active Ingredients Disodium Phosphate Dodecahydrate, Sodium Dihydrogen Phosphate Dihydrate
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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 11 January 2017 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility

Updated on 11 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 August 2016 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to date of revision

Updated on 30 May 2016 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 1 (Name of medicinal product) the word Fleet has been deleted.
In section 10 (date of revision) has been updated to April 2016

Updated on 30 May 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 16 November 2015 PIL

Reasons for updating

  • Change of manufacturer
  • Change of licence holder
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to marketing authorisation holder
  • Change to improve clarity and readability
  • Change of distributor details

Updated on 12 November 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 7 MA holder has been changed to Casen Recordati S.L, MA holders address remains the same.
Section 8 MA Number has been changed to PA2028/004/001
Section 10 Revision Date is July 2015

Updated on 6 August 2015 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 2 - Addition of Excipient(s) with known effect heading
Section 2- Editorial amendments.
Section 4.1 - Addition of line Fleet Phospho-soda is indicated in adults.
Section 4.2 - Addition of the headings Posology and Method of administration.
Section 4.2- Fleet Phospho-soda 24.4g/10.8g Oral solution has been replace with Fleet Phospho-soda
Section 4.3 - The following sentence has been changed from There is a hypersensitivity to the active ingredients or any excipients to There is a hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Section 4.4- Fleet Phospho-soda 24.4g/10.8g Oral solution has been replace with Fleet Phospho-soda
Section 4.5- Fleet Phospho-soda 24.4g/10.8g Oral solution has been replace with Fleet Phospho-soda
Section 4.6- Updated in line with QRD template.
Section 4.6- Fleet Phospho-soda 24.4g/10.8g Oral solution has been replace with Fleet Phospho-soda
Section 4.7- Fleet Phospho-soda 24.4g/10.8g Oral solution may cause dizziness, probably as a result of dehydration, and this may have a mild to moderate effect on the ability to drive or use machinery. Fleet Phospho-Soda has minor to moderate influence on the ability to drive and use machines.
Section 4.8 - Editorial amendments.
Section 4.8 - Reporting of Suspected adverse reactions has been updated in line with the QRD template.
Section 4.9 - Fleet Phospho-soda 24.4g/10.8g Oral solution has been replace with Fleet Phospho-soda
Section 5.1 - A06AD – Osmotically acting laxative has been updated to Pharmacotherapeutic group:  Osmotically acting laxative, ATC code: A06AD17
Section 5.1- Fleet Phospho-soda 24.4g/10.8g Oral solution has been replace with Fleet Phospho-soda
Section 6.5 -Fleet Phospho-soda 24.4g/10.8g Oral solution has been replace with Fleet Phospho-soda
Section 6.6- Heading has been amended to Special precautions for disposal and other handling
Section 9 - Updated in line with QRD template.
Section 10- Revision date has been amended to June 2015

Updated on 28 May 2015 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 27 May 2015 PIL

Reasons for updating

  • New PIL for medicines.ie