Phospho-soda 24.4g / 10.8g oral solution
*Company:
Casen Recordati, S.L.,Status:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 11 July 2022
File name
IE_Phosphosoda_SPmC_032022.pdf
Reasons for updating
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 July 2022
File name
IE_Phosphosoda_PIL_03.2022.pdf
Reasons for updating
- Change to section 4 - how to report a side effect
Updated on 06 April 2022
File name
IE_Phosphosoda_SmPC_032022.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 April 2022
File name
IE_Phosphosoda_PIL_03.2022.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Updated on 19 June 2020
File name
IE_Phosphosoda_SPmC_072019.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- 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 4.6 - Pregnancy and lactation
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 19 June 2020
File name
IE_Phosphosoda_PIL_05.2019.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
Updated on 11 January 2017
File name
PIL_16337_202.pdf
Reasons for updating
- New PIL for new product
Updated on 11 January 2017
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
Updated on 30 August 2016
Reasons for updating
- Change of trade or active ingredient name
- Change to date of revision
Updated on 30 May 2016
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 May 2016
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 10 (date of revision) has been updated to April 2016
Updated on 16 November 2015
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
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 8 MA Number has been changed to PA2028/004/001
Section 10 Revision Date is July 2015
Updated on 06 August 2015
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
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
Updated on 27 May 2015
Reasons for updating
- New PIL for medicines.ie