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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: 16/12/2011
SPC Iopidine 5mg/ml 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 16/12/2011 and displayed until Current
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 4.3 - 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • 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 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Oct-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Sec 2, 4.1 : rewording (mainly removal of 5mg/ml)

Sec 4.2: replacement of a statement and rewording.

4.3: removal of 5mg/ml

4.4: rewording and removal of 5mg/ml; addition of new statement “avoid contact with soft contact lenses”

Sec4.5: addition of two new statement at the start and end of the section

Sec 4.6: amendment as per QRD template

Sec4.7: rewording

Sec4.8: rewriting to be in line with QRD and MedRA classification

Sec 4.9: slight amendment: addition of “lukewarm”

Sec 5.1: rewording

Sec 6.1: amendment of text

6.3: rewording

6.4: rewording and replacement of “moisture” with “light”

Sec 6.6 and 8: change in the title

Sec 9 : addition of renewal date

Sec 10: date revision

Updated on 01/03/2011 and displayed until 16/12/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   17-Jan-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
In Section 2, Qualitative and quantitative composition, ‘For excipients, see section 6.1.’ is replaced by ‘For a full list of excipients, see section 6.1.’

In Section 6.1, List of excipients, 0.1mg/ml is added against Benzalkonium Chloride.

In Section 9, Date of first authorisation/ renewal of authorisation, the date of last renewal is updated.

In Section 10, Date of revision of the text, the date of revision is updated.
Updated on 13/08/2010 and displayed until 01/03/2011
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   29-Apr-2005
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company


Section 9 and Section 10 - dates updated.
Updated on 19/05/2005 and displayed until 13/08/2010
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 12/06/2003 and displayed until 19/05/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Apraclonidine Hydrochloride