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Alcon Laboratories (U.K) Limited
Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7UD
Telephone: +44 (0)1442 341 234
Fax: +44 (0)1442 341 200

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: 27/09/2011
SPC Vexol 1% Eye Drops, Suspension

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 27/09/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


SmPC has been updated in line with the Company Core Safety Information.

Updated on 27/08/2009 and displayed until 27/09/2011
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   30-Sep-2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3 - deleted 'and in those persons with hypersensitivity to any component of this preparation'

Section 4.4 - reference to contact lenses added and reference to steroids and BAK removed

Section 4.7 - deleted ' Unknown. Transient, blurred vision may occur immediately after administration. Do not drive or operate machinery if affected.'

Section 4.8 - whole section amended to Medra terminology

Section 4.9 - deleted 'A topical overdosage of Vexol may be flushed from the eye(s) with luke warm tap water.'
Updated on 15/11/2002 and displayed until 27/08/2009
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 17/08/2001 and displayed until 15/11/2002
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 13/07/2001 and displayed until 17/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 22/06/2001 and displayed until 13/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/04/2001 and displayed until 22/06/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  rimexolone