Drynol 2.5 mg/ml oral solution

  • Company:

    A. Menarini Pharmaceuticals Ireland 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

Updated on 02 March 2023

File name

ie-spc Drynol OS - Clean Approved Feb 23.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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • 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

Section 2 - Ethanol content added

Section 4.4 - Ethanol content warnings added

Section 4.8 - Rare and Very Rare headers updated for accuracy

Section 4.8 - AE reporting details updated

Section 6.1 - E Number added

Section 10 - Date of revision updated

Updated on 02 March 2023

File name

ie-pl OS - Clean Apporoved Feb 23.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Excipient warnings added for Ethanol content, E numbers added and date of revision updated

Updated on 13 July 2022

File name

ie-spc Drynol OS Renewal clean July 22.pdf

Reasons for updating

  • Correction of spelling/typing errors

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 13 July 2022

File name

ie-spc Drynol OS Renewal clean July 22.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 2 - Updated information for interactions with Diltiazem

Section 6 - Date of revision updated

Updated on 05 May 2021

File name

ie-spc Drynol OS Sodium Warning Clean Dec 20.pdf

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 - Information added regarding sodium content

Section 10 - Date of revision updated 

Updated on 05 May 2021

File name

ie-pl OS Sodium Warning Clean Dec 20.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 2 - Excipient warning for Sodium Content Added

Section 6 - Date of revision updated 

 

Updated on 18 August 2020

File name

ie-pl OS clean 15-7-20.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The change is to update the Patient Leaflet by listing serious or life-threatening side effects at the beginning of section 4 - Possible side effects, irrespective of the frequency.

Updated on 11 June 2019

File name

ie-spc Drynol OS clean 8-3-19.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 21 May 2019

File name

ie-pl OS clean 8-3-19.pdf

Reasons for updating

  • New PIL for new product