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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: 10/06/2011
SPC Maxidex Eye Drops

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 10/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In Section 6.3, Shelf life, the shelf life of the product has  been changed to 20 months, this is following a quality update.

In Section 10, Date of revision of the text, the date of revision is updated.
Updated on 06/04/2011 and displayed until 10/06/2011
Reasons for adding or updating:
  • 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 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   28-Mar-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
In Section 4.3, Contraindications, ‘Acute, untreated purulent bacterial infections’ is added, and the whole section is reformatted.

In Section 4.4, Special warnings and precautions for use, additional safety information on corticosteroid usage and prolonged use of topical ophthalmic corticosteroids has been added, and the whole section is reformatted.

In Section 4.5, Interactions with other medicinal products and other forms of interaction, the following statement is added – ‘If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.’

In Section 4.6, Pregnancy and lactation, additional safety information on the use of Maxidex in pregnancy and during breast-feeding has been added.

In Section 4.7, Effects on ability to drive and use machines, the following statements are added – ‘Maxidex has no or negligible influence on the ability to drive and use machines. As with any topical ophthalmic medicinal product, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.’

In Section 4.8, Undesirable effects, the section is replaced with a summary of the safety profile, a tabulated list of adverse reactions, and a description of selected adverse reactions

In Section 4.9, Overdose, the following statement has been added – ‘An ocular overdose of Maxidex can be flushed from the eye(s) with lukewarm water.’

In Section 5.3, Preclinical data, additional preclinical data has been added.

In Section 10, Date of revision of the text, the date of revision is updated.
Updated on 04/06/2008 and displayed until 06/04/2011
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 Section 9 Date of Renewal
Updated on 27/01/2005 and displayed until 04/06/2008
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 19/06/2003 and displayed until 27/01/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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