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Exterol 5% w/w Ear Drops, Solution

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Pharmacy Only: Non-prescription

Updated on 23 January 2023

File name

EXTL-IPHA.SPC.pdf

Reasons for updating

  • Document format updated

Legal category:Supply through pharmacy only

Updated on 18 May 2022

File name

EXTL-IPHA.PIL.SP14-21-2.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 24 June 2021

File name

EXTL-IPHA.PIL.SP11-21-1a.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Change to further information section

Updated on 24 June 2021

File name

EXTL-IPHA.SPC.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

Legal category:Supply through pharmacy only

Updated on 10 February 2021

File name

EXTL-IPHA.PIL.SP11-20-1.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 December 2020

File name

EXTL-IPHA.SPC.pdf

Reasons for updating

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

Legal category:Supply through pharmacy only

Updated on 31 August 2018

File name

EXTL-IPHA.SPC.07.07.15.10.07.15.pdf

Reasons for updating

  • File format updated to PDF

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

File format updated to PDF

Updated on 10 July 2015

File name

PIL_8661_67.pdf

Reasons for updating

  • New PIL for new product

Updated on 10 July 2015

Reasons for updating

  • New SPC for new product

Legal category:Supply through pharmacy only

Updated on 10 July 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

Legal category:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

In section 4.8 Undesirable effects, the following text has been added:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important.  It allows continued monitoring of the benefit/risk balance of the medicinal product.  Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517.  Website: www.hpra.ie; E-mail:medsafety@hpra.ie.

In section 10 Date of revision of the text, the date has changed to "June 2015"

Updated on 10 July 2015

Reasons for updating

  • Change to date of revision
  • Addition of information on reporting a side effect.

Updated on 13 October 2014

Reasons for updating

  • Change to date of revision
  • Removal/change of distributor

Updated on 20 January 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 10 July 2007

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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:Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1: Text changed to "Exterol 5% w/w Ear Drops, Solution"
 
Section 2: Text added "For a full list of excipients, see section 6.1"
 
Section 3: Text changed to "Ear drops, solution. Clear, straw-coloured viscous solution" 
 
Section 6.3: Text added "Discard 4 weeks after first opening"
 
Section 6.4: Text changed to "Store upright. Do not store above 250C. Keep the bottle tightly closed. Keep the bottle in the outer carton"
 
Section 6.5: Text changed to "8 ml easy squeeze plastic dropper bottle with screw cap"
 
Section 6.6: Text changed to "No special requirements"
 
Section 9: Date changed to "28 January 2007"
 
Section 10: Date changed to "January 2007" 

Updated on 10 July 2007

Reasons for updating

  • Change of trade or active ingredient name
  • Change to storage instructions

Updated on 07 September 2004

Reasons for updating

  • New PIL for medicines.ie

Updated on 19 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through pharmacy only