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Brolene 0.15% w/w Eye Ointment

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/03/18

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Summary of Product Characteristics last updated on medicines.ie: 15/3/2018
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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 15 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 15 March 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 4.8 added:-

Eye disorders:

Not known:  Eye pain or irritation, usually in the form of a stinging or burning sensation.  In such cases use should be discontinued immediately.  If symptoms persist medical advice should be sought.

Immune system disorders:

Not known

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.

Updated on 14 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 14 March 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 12 August 2015 PIL

Reasons for updating

  • Change to storage instructions

Updated on 27 November 2014 SmPC

Reasons for updating

  • 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

Free text change information supplied by the pharmaceutical company

Section 6.3: Shelf-life reduced from 2 years to 18 months.
Section 6.4: Storage changed from Store between 2oC to Store below 25oC.

Updated on 15 May 2014 SmPC

Reasons for updating

  • SPC re-instated

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

SPC reverted back to previous version

Updated on 12 May 2014 PIL

Reasons for updating

  • PIL re-instated

Updated on 1 April 2014 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 6.3: Shelf-life reduced to 18 months.
Section 6.4: Storage conditions changed to 'Store below 25C'

Updated on 28 March 2014 PIL

Reasons for updating

  • Change to storage instructions

Updated on 10 September 2013 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

None provided

Updated on 24 May 2013 PIL

Reasons for updating

  • Change to storage instructions

Updated on 14 October 2008 PIL

Reasons for updating

  • Improved electronic presentation
  • PIL - Product no longer marketed in Ireland

Updated on 17 September 2007 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 December 2006 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie