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Merck Sharp & Dohme 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: 10/03/2011
SPC ZOCOR Tablets

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 10/03/2011 and displayed until Current
Reasons for adding or updating:
  • 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 4.8 - Undesirable effects
Date of revision of text on the SPC:   28-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Updated adverse events - Sections 4.4, 4.5, 4.8.

 
Updated on 17/02/2011 and displayed until 10/03/2011
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 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   31-Jan-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Additional warnings - Contraindications / updated storage conditions

 
Updated on 07/05/2010 and displayed until 17/02/2011
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   28-Apr-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Change to sections 4.2, 4.4, 4.5, 4.8, 5.1
II25 (safety - Cholesterol, Homocysteine), II28 (safety - based on HPS2 THRIVE)

 
Updated on 06/04/2010 and displayed until 07/05/2010
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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   01-Mar-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Change to sections 4.2, 4.4, 4.8, 5.1, 5.2
II23 (insomnia, memory impairment), II27 (paediatric worksharing)

 

 

 

 
Updated on 10/03/2010 and displayed until 06/04/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   26-Feb-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


Change to sections 2 and 6.1 (renewal completion).
More detailed information on excipients.

 
Updated on 15/07/2008 and displayed until 10/03/2010
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
4.2 Posology and method of administration – removal of niacin dose cap
4.4 Special warnings and precautions for use – removal of niacin dose cap and interaction with fusidic acid
4.5 Interaction with other medicinal products and other forms of interaction – removal of niacin dose cap and interaction with fusidic acid
4.8 Undesirable effects – addition of very rarely hepatic failure
Updated on 07/02/2008 and displayed until 15/07/2008
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 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

The changes are to Sections 4.2; 4.4 and 4.5.
Updated on 20/09/2007 and displayed until 07/02/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   09/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

SPC for Zocor - the change is to section 4.8 (to include hepatic failure).
Updated on 19/02/2007 and displayed until 20/09/2007
Reasons for adding or updating:
  • Change to marketing authorisation holder
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Cahnge of PA licence holder from Merck, Sharp and Dohme to Merck Sharp and Dohme Ireland Human Health Ltd
Updated on 12/05/2006 and displayed until 19/02/2007
Reasons for adding or updating:
  • 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
Updated on 17/05/2004 and displayed until 12/05/2006
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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties
Updated on 10/12/2003 and displayed until 17/05/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 18/11/2003 and displayed until 10/12/2003
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Updated on 25/09/2003 and displayed until 18/11/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Change to section 5.1 - Pharmacodynamic properties
Updated on 13/08/2003 and displayed until 25/09/2003
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.3 - Shelf life
Updated on 19/06/2003 and displayed until 13/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Simvastatin