« Back to Medicines list

Brolene 0.15% w/w Eye Ointment

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

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 15/3/2018
print

Print ViewKeyword Search SmPC

SANOFI

SANOFI

Company Products

Medicine NameActive Ingredients
Medicine Name Adenocor Active Ingredients Adenosine
Medicine Name Amaryl 1mg Tablets Active Ingredients Glimepiride
Medicine Name Amaryl 3mg Tablets Active Ingredients Glimepiride
Medicine Name Anthisan Cream Active Ingredients Mepyramine Maleate
Medicine Name Apidra 100 units/ml solution for injection in a cartridge Active Ingredients Insulin Glulisine
Medicine Name Apidra 100 Units/ml solution for injection in a vial Active Ingredients Insulin Glulisine
Medicine Name Apidra SoloStar 100 units/ml solution for injection in a pre-filled pen Active Ingredients Insulin Glulisine
Medicine Name Aprovel 150mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Aprovel 300mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Aprovel 75mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Arava 10 mg film-coated tablets Active Ingredients Leflunomide
Medicine Name Arava 20 mg film-coated tablets Active Ingredients Leflunomide
Medicine Name Bisolvon Oral Solution Active Ingredients Bromhexine hydrochloride
Medicine Name Brolene 0.1%w/v Eye Drops Solution Active Ingredients Propamidine Isethionate
Medicine Name Brolene 0.15% w/w Eye Ointment Active Ingredients Dibromopropamidine Isethionate
Medicine Name Buscopan 10 mg Coated Tablets Active Ingredients hyoscine butylbromide
Medicine Name Buscopan Ampoules Active Ingredients hyoscine butylbromide
Medicine Name Buscopan Rx 10mg Coated Tablets Active Ingredients hyoscine butylbromide
Medicine Name Calcium Resonium Active Ingredients Calcium polystyrene sulfonate
Medicine Name Cerubidin 20mg Powder for Solution for Injection Active Ingredients daunorubicin hydrochloride
Medicine Name Cidomycin Paediatric 20mg/2ml Solution For Injection Active Ingredients Gentamicin sulfate
Medicine Name Claforan Powder for Solution for Injection 1g Active Ingredients Cefotaxime sodium
Medicine Name Claforan Powder for Solution for Injection 500mg Active Ingredients Cefotaxime sodium
Medicine Name Clexane 10,000 IU (100mg)/1ml Solution for Injection Active Ingredients Enoxaparin sodium
Medicine Name Clexane 2,000 IU (20 mg) /0.2 mL Solution for Injection Active Ingredients Enoxaparin sodium
1 - 0 of 175 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 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