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

Summary of Product Characteristics last updated on the eMC: 18/09/2007
SPC Minims Lidocaine & Fluorescein

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 18/09/2007 and displayed until Current
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 03/10/2005 and displayed until 18/09/2007
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
   fluorescein sodium
   lidocaine hydrochloride