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MSD Ireland (Human Health) Limited
Pelham House, South County Business Park, Leopardstown, Dublin 18, Ireland
Telephone: +353 1 299 8700
Fax: +353 1 299 8701
Medical Information e-mail: medinfo_ireland@merck.com
Summary of Product Characteristics last updated on medicines.ie: 28/05/2010
SPC COSOPT

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 28/05/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   14-May-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Section 4.4
Therefore, the same types of adverse reactions found with systemic administration of sulfonamides may occur with topical administration, including severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Section 4.8

Skin and subcutaneous tissue disorders:

COSOPT:

Rare: contact dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis

 
Updated on 25/03/2010 and displayed until 28/05/2010
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   09-Mar-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
6.4 Special precautions for storage
This medicinal product does not require any special temperature storage conditions.
Keep the bottle in the outer carton, in order to protect from light.

 

 

 
Updated on 23/10/2009 and displayed until 25/03/2010
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
Date of revision of text on the SPC:   09-Oct-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


PA transfer details to:
PA 1286/6/1
Merck Sharp & Dohme Ireland (Human Health) Limited
Pelham House
South County Business Park
Leopardstown
Dublin 18

 


 
Updated on 07/10/2009 and displayed until 23/10/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   31-Aug-2009
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Section 2: Reference to Benzalkonium
Section 4.2 : Update details on usage instructions
Section 4.5: Delete paragraph relating to clinical trial studies.
Updated on 28/04/2008 and displayed until 07/10/2009
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The change relates to section 4.5 as follows:

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, SSRIs) and timolol, possibly because quinidine inhibits the metabolism of timolol via the P-450 enzyme, CYP2D6.
Updated on 06/03/2007 and displayed until 28/04/2008
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   02/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Cahnges to SPC following EU worksharing project assessment of paediatric data
Updated on 19/06/2003 and displayed until 06/03/2007
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Dorzolamide Hydrochloride
  Timolol Maleate