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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: 13/08/2010
SPC Iopidine 1% Eye Drops Solution

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 13/08/2010 and displayed until Current
Reasons for adding or updating:
  • 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 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • 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-2006
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
Section 4.5 - 'The risk of clinically relevant interactions appears low considering the plasma levels of apraclonidine given by the ocular route.' and 'caution is advised in patients taking tricyclic antidepressants which can affect metabolism and uptake of circulating amines' has been added.

Section 4.6 - Section amended to include there is no adequate data from the use of Iopidine in pregnant women, and caution should  be exercised when Iopidine is administered to nursing women.

Section 4.8 - Section updated to MEDRA coding.

Section 4.9 - Information on overdosage in a 2month old child has been added.

Section 6.1 - 'Preservative Free' removed.

Section 6.4 - 'In order to protect from light' removed.

Section 6.5 - Additional pack sizes included.

Section 10 - Date of revision changed to July 2006.
Updated on 13/06/2003 and displayed until 13/08/2010
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Apraclonidine Hydrochloride