Brolene 0.15% w/w Eye Ointment
Product Information *
Company:
SANOFIStatus:
UpdatedActive Ingredients :
*Additional information is available upon request
Legal Category:
Supply through pharmacy only
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 12 July 2021
File name
PIL_8356_521_1626105401.pdf
Reasons for updating
- XPIL Removed
Updated on 06 July 2020
File name
PIL_8356_521.pdf
Reasons for updating
- XPIL Removed
Updated on 15 March 2018
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Updated on 15 March 2018
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
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 14 March 2018
File name
PIL_8356_521.pdf
Reasons for updating
- New PIL for new product
Updated on 12 August 2015
Reasons for updating
- Change to storage instructions
Updated on 27 November 2014
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 6.4: Storage changed from Store between 2oC to Store below 25oC.
Updated on 15 May 2014
Reasons for updating
- SPC re-instated
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 12 May 2014
Reasons for updating
- PIL re-instated
Updated on 01 April 2014
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 6.4: Storage conditions changed to 'Store below 25C'
Updated on 28 March 2014
Reasons for updating
- Change to storage instructions
Updated on 10 September 2013
Reasons for updating
- New SPC for new product
Legal category:Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Updated on 24 May 2013
Reasons for updating
- Change to storage instructions
Updated on 14 October 2008
Reasons for updating
- Improved electronic presentation
- PIL - Product no longer marketed in Ireland
Updated on 17 September 2007
Reasons for updating
- Improved electronic presentation
Updated on 18 December 2006
Reasons for updating
- Improved electronic presentation
Updated on 19 August 2004
Reasons for updating
- New PIL for medicines.ie