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Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 452 206
Medical Information e-mail: medicalinformationuk@merck.com
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Summary of Product Characteristics last updated on the eMC: 25/01/2010
SPC Zocor 10mg, 20mg, 40mg and 80mg film-coated tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 25/01/2010 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:   18-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 - This paragraph has been added-

Interstitial lung disease

Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8). Presenting features can include dyspnoea, non-productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.

 

Section 4.8- the following side-effects have been added-

memory impairment, sleep disturbances, including insomnia and nightmares, sexual dysfunction, depression, exceptional cases of interstitial lung disease, especially with long term therapy.

Also some of this section has been re-formatted.
Updated on 29/10/2009 and displayed until 25/01/2010
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   12-Oct-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.4 of the SmPC has been revised as the storage statement has been changed from "Do not store above 30°C" to "Do not store above 25°C".

Updated on 21/04/2009 and displayed until 29/10/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   10-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2 - the quantities of lactose have been added.

Section 4.6- minor editorial revisions

Section 6.1 - Changes to the layout of the excipients.
Updated on 09/12/2008 and displayed until 21/04/2009
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-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.2 - Reference to niacin has been removed from the section on concomitant therapy.

4.4 - Under the sub -heading "Measures to reduce the risk of myopathy caused by medicinal product interactions" Niacin has been removed from the 4th paragraph.

4.5 - Niacin has been removed from the table of drug interactions associated with increased risk of myopathy/rhabdomyolysis.
Updated on 25/02/2008 and displayed until 09/12/2008
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:   02/2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of an interaction with fusidic acid in section 4.5.
Updated on 15/11/2007 and displayed until 25/02/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   10/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

The only change to the SPC is the inclusion of hepatic failure to section 4.8 under the sub-heading of 'Hepato-biliary disorders'.
Updated on 30/01/2006 and displayed until 15/11/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 27/01/2006 and displayed until 30/01/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 02/11/2005 and displayed until 27/01/2006
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 02/11/2005 and displayed until 02/11/2005
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 04/08/2004 and displayed until 02/11/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 03/08/2004 and displayed until 04/08/2004
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 05/01/2004 and displayed until 03/08/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 10/12/2003 and displayed until 05/01/2004
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 - Interactions with other Medicaments and other forms of Interaction
Updated on 20/11/2003 and displayed until 10/12/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 19/11/2003 and displayed until 20/11/2003
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
Updated on 18/11/2003 and displayed until 19/11/2003
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
Updated on 18/09/2002 and displayed until 18/11/2003
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 16/08/2001 and displayed until 18/09/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 11/05/2000 and displayed until 16/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/04/2000 and displayed until 11/05/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 06/04/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  simvastatin


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