Distaclor 125mg/5ml Granules for Oral Suspension
*Company:
Flynn Pharma LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 24 June 2022
File name
PIL mockup OS 2022 06 23.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Update to MAH address
Updated on 24 June 2022
File name
SmPC 125mg OS 2022 06 23.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to MAH address
Updated on 03 March 2021
File name
Distaclor Suspension PIL 2021 03 02.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Free text change information supplied by the pharmaceutical company
To confirm that as there is less than 1mmol of sodium per dose; the medicine is considered essentially sodium free
Updated on 03 March 2021
File name
Distaclor 125mg suspension SmPC.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
To confirm that as there is less than 1mmol of sodium per dose; the medicine is considered essentially sodium free
Updated on 19 January 2021
File name
Distaclor SmPC 125mg suspension 2018.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 March 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 March 2018
Reasons for updating
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 28 February 2018
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 05 February 2018
File name
PIL_17393_720.pdf
Reasons for updating
- New PIL for new product
Updated on 05 February 2018
Reasons for updating
- Change to section 6 - manufacturer
Updated on 10 January 2018
Reasons for updating
- New PIL for medicines.ie
Updated on 16 August 2016
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 July 2012
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 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 4.4- "Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase - isomaltaseinsufficiency should not take this medicine."- added
In section 9- date of last renewal is changed to "16th june 2008"
in section 10- date of revision of text is changed to "august 2009"
Updated on 14 March 2007
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)