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FDC International Ltd
Unit 6 Fulcrum1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE
Telephone: +44 (0)1489 565222
Fax: +44 (0)1489 565222
WWW: http://www.fdcindia.com
Medical Information e-mail: fdcil@btconnect.com

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: 13/01/2012
SPC Betaxolol 0.5% 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 13/01/2012 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:   05-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.2 added this below statement$0$0$0$0Whenusing nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemicabsorption is reduced. This may result in a decrease in systemic side effectsand an increase in local activity$0$0$0$0$0$0$0In section 4.3 $0$0$0$0$0$0sicksinus syndrome sino-atrial block, Secondor third degree AV block not controlled with pace-maker, Reactiveairway disease including severe bronchial asthma or a history of severebronchial asthma, severe chronic obstructive pulmonary disease,Hypersensitivityto the active substance (betaxolol), to any of the excipients have been added$0$0$0$0$0$0In section 4.4, 4.5, 4.6, 4.8$0$0Almost rearranged whole sections with new information for example  Section 4.8 of the SPC has been reviewed and all adverse event terms and frequencies re-inserted.$0$0$0$0
Updated on 19/11/2009 and displayed until 13/01/2012
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  betaxolol hydrochloride