Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

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: 10/04/2012
SPC Betoptic Suspension Single Dose

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 10/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Mar-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


There are a large number of changes made to the SmPC.  The following changes have been made:

Change to update sections 4.2, 4.3, 4.4, 4.5, 4.6 and 4.8 of the SPC and PIL in line with the agreed PhVWP/CMD(h) wording regarding the system adverse drug reactions after ophthalmic administration of beta-blocking agents for ophthalmic use.
Updated on 04/01/2012 and displayed until 10/04/2012
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   19-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Storage conditions changed as follow:

Do not store above 25°C.

Do not freeze.

Store in the original package in order to protect from light.
Updated on 07/12/2011 and displayed until 04/01/2012
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Sep-2003
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Revision date updated in line with approval date of variation.
Updated on 14/05/2004 and displayed until 07/12/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 21/08/2001 and displayed until 14/05/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 06/07/2001 and displayed until 21/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 22/06/2001 and displayed until 06/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 08/12/2000 and displayed until 22/06/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  betaxolol hydrochloride