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Brolene 0.15% w/w Eye Ointment

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/07/20

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Summary of Product Characteristics last updated on medicines.ie: 15/3/2018
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1 - 0 of 166 items.Total: Infinity pages

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 6 July 2020 PIL

Reasons for updating

  • XPIL Removed

Updated on 15 March 2018 SPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only

Updated on 15 March 2018 SPC

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 SPC

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 SPC

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 SPC

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 SPC

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