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Bausch & Lomb U.K Limited
Bausch & Lomb House, 106 London Road, Kingston-upon-Thames, Surrey, KT2 6TN, UK
Telephone: +44 (0)208 781 2900
Fax: +44 (0)208 781 2901
Medical Information Direct Line: +44(0)1748 828849 or 08 1871 9318
Medical Information e-mail: medicalinformationuk@bausch.com
Customer Care direct line: +44 (0)208781 2991

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 18/11/2010
SPC Minims Proxymetacaine hydrochloride 0.5% w/v & Fluorescein sodium 0.25% w/v

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 18/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   02-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.3, the shelf-life has been changed from 18 months to 15 months.
Updated on 30/07/2008 and displayed until 18/11/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   01-Jun-2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2: Change from Fluorescein sodium “BP” to “Ph. Eur”.
Updated on 21/09/2007 and displayed until 30/07/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
section 4.8 (undesirable effects)
 
 

ADRs are very rare(<1/10,000),including isolated reports.

 

Symptoms of allergic-type reactions and anaphylaxis have been reported following topical ophthalmic administration of Fluorescein sodium and may manifest as:

 

Eye disorders: allergic conjunctivitis, peri-orbital oedema

Immune system disorders: anaphylactic reaction

Skin and subcutaneous tissue disorders: urticaria, rash
Updated on 15/09/2003 and displayed until 21/09/2007
Reasons for adding or updating:
  • New SPC for new product
Updated on 31/07/2001 and displayed until 15/09/2003
Reasons for adding or updating:
  • No reasons supplied
Updated on 08/09/2000 and displayed until 31/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 08/09/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  fluorescein sodium
  proxymetacaine hydrochloride