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Alcon Laboratories (U.K) Limited

Alcon Laboratories (U.K) Limited
Pentagon Park, Boundary Way, Hemel Hempstead, Herts, HP2 7UD , UK
Telephone: +44 (0) 1442 341 234
Fax: +44 (0) 1442 341 280
Medical Information Direct Line: +44 (0) 1442 341 192
Medical Information e-mail: ukmedical@alconlabs.com
Summary of Product Characteristics last updated on medicines.ie: 02/12/2011
SPC Betoptic Suspension Single Dose 0.25%

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 02/12/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   17-Oct-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Sec 6.4: Change the conditions of storage and labeling to “Do not store above 25°C. Do not freeze. Store in the original package in order to protect from light"
Updated on 07/11/2011 and displayed until 02/12/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Oct-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Sec 2: amended to: For a full list of excipients, see section 6.1

Sec 6.3: addition of text: Once opened use immediately.

Discard any unused contents immediately after use.

Sec 6.4: Deletion of: Discard any unused contents immediately after use.

Sec 10: revision date amended

In addition title and sub-titles amended to be in line with the QRD template.

Updated on 06/11/2009 and displayed until 07/11/2011
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   30-Dec-2005
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.9 - 'Treatment of accidental ingestion should be symptomatic and supportive' has been added
Updated on 15/08/2007 and displayed until 06/11/2009
Reasons for adding or updating:
  • Change to improve clarity and readability
Date of revision of text on the SPC:   08/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 
   4.3 Clearer iformation and clarity
Updated on 25/05/2005 and displayed until 15/08/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Betaxolol Hydrochloride

Versions

 
02/12/2011 to Current
07/11/2011 to 02/12/2011
06/11/2009 to 07/11/2011
15/08/2007 to 06/11/2009
25/05/2005 to 15/08/2007
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Registered Address: Franklin House, 140 Pembroke Road, Dublin 4, Ireland
Registered Number: 254776
Tel: (353 1) 6603350 Fax: (353 1) 6686672 Email: info@ipha.ie

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