Exterol 5% w/w Ear Drops, Solution
- Name:
Exterol 5% w/w Ear Drops, Solution
- Company:
Dermal Laboratories Limited
- Active Ingredients:
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/02/21

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Dermal Laboratories Limited

Company Products
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 10 February 2021 PIL
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 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only
Updated on 10 July 2015 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 10 July 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 13 October 2014 PIL
Reasons for updating
- Change to date of revision
- Removal/change of distributor
Updated on 20 January 2011 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 10 July 2007 PIL
Reasons for updating
- Change of trade or active ingredient name
- Change to storage instructions
Updated on 10 July 2007 SPC
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
Updated on 7 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 19 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Supply through pharmacy only