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Alcon Laboratories (U.K) Limited
Pentagon Park, Boundary Way, Hemel Hempstead, Hertfordshire, HP2 7UD
Telephone: (0)871 376 1402
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: 15/05/2012
SPC Tobradex Eye Drops

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 15/05/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   02-Apr-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
reduction of shelf life from 36 months to 2 years.  Section 6.3 is impacted.
Updated on 21/07/2010 and displayed until 15/05/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Jul-2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 - 0.3% w/v ml and 0.1% w/v ml removed.

Section 4.1 - Intraocular and ocular surface bacterial contamination added.

Section 4.2 - Dosing should continue for 14 days not to exceed a maximum of 24 days added.

Section 4.6 - Information on treatment during pregnancy added.

Section 5.1 - This action culminates in a reduced expression of pro-inflammatory mediators and the suppression of adhesion of circulating leukocytes to the vascular endothelium, thereby preventing their migration into inflamed ocular tissue has been added.

Section 5.2 - Quantifiable concentration information has been removed.

Section 5.3 - The systemic toxicity profile of the individual actives is well established. Preclinical effects of tobramycin and dexamethasone were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to human use has been kept all other infromation has been removed.

Section 6.5 - Pack size: 1x5 ml has been added.

Section 10 - Date has been updated to to July 2005.
Updated on 13/03/2003 and displayed until 21/07/2010
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 13/08/2001 and displayed until 13/03/2003
Reasons for adding or updating:
  • Addition of Black Triangle
  • Transferred from eMC version 1
Updated on 22/06/2001 and displayed until 13/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 31/05/2001 and displayed until 22/06/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  dexamethasone
  tobramycin