Exterol 5% w/w Ear Drops, Solution *

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 24 June 2021

File name

EXTL-IPHA.PIL.SP11-21-1a_1624535716.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_1624535379.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_1612969578.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_1608206705.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_1535725381.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

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

  • New SPC for new product

Legal category:Supply through pharmacy only

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

  • 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