Distaclor 125mg/5ml Granules for Oral Suspension *

  • Company:

    Flynn Pharma Ltd
  • Status:

    No Recent Update
  • Legal 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

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 03 March 2021

File name

Distaclor Suspension PIL 2021 03 02_1614770419.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_1614770161.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_1611074008.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

  • 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

update revision date as per request from HPRA

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 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

Update MA holder address

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

Update Annex V information encouraging reporting of adverse events. Several additional minor changes to the product information to align with the QRD template.

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 2 - "Excipient: Sucrose 3g/5ml" Added
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)