eMC Medicine Guides  
The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
go to eMC homepage
Search for:  
  Advanced Search

Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 03/01/2012
SPC Lipitor 10mg, 20mg, 40mg, 80mg 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 03/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC update to section 6.5
Updated on 22/09/2011 and displayed until 03/01/2012
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 16/09/2011 and displayed until 22/09/2011
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   01-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC update to section 6.5, 7 & 8
Updated on 14/03/2011 and displayed until 16/09/2011
Reasons for adding or updating:
  • Change due to harmonisation of SPC
Date of revision of text on the SPC:   01-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The SPC has been updated to become harmonised throughout the EU
Updated on 25/11/2010 and displayed until 14/03/2011
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 4.4 - 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
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SmPC The following sections have been updated with wording regarding treatment of children age 10 and over with atorvastatin: 4.1, 4.2, 4.4, 4.5, 4.8, 5.1, 5.2
Updated on 04/06/2010 and displayed until 25/11/2010
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change of inactive ingredient
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to Section 3: Pharmaceutical form - change to appearance of the medicine.
Change of inactive ingredient.
Updated on 18/05/2010 and displayed until 04/06/2010
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
  • SPC Retired pending re-submission
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2

Introduction of cross-reference to section 4.4

 Section 4.4

Insertion of sentence on renal impairment being a risk factor for rhabdomyolysis

Introduction of text on Interstitial lung disease

Section 4.5

Correction of detail in section regarding interactions with erythromycin and clarithromycin

Section 4.8

  • Revision of section 4.8 in line with update to core data sheet following review of side effects including addition of side effects from PhVWP statin review (Sleep disturbances, including insomnia and nightmares, Memory loss, Sexual dysfunction, Depression, Exceptional cases of interstitial lung disease, especially with long term therapy (see Section 4.4).)

 
Updated on 20/04/2010 and displayed until 18/05/2010
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Tablets changed shape and markings.

Change to excipients.
Updated on 24/12/2009 and displayed until 20/04/2010
Reasons for adding or updating:
  • 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
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update section 4.2 of the SmPC in line with the Core Data Sheet

to include a cross reference to section 4.4 and to include a history of renal impairment may be a risk factor for the development of rhabdomyolysis.

 

Update section 4.5 of the SmPC

to amend numerical values within sections of interactions for Clarithromycin and Erythromycin.

 

Update section 4.8 of the SmPC in line with the Core Data Sheet

due to an update following a review of the pooled data from its placebo-controlled studies.

 
Updated on 03/12/2009 and displayed until 24/12/2009
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:   02-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to section 4.4 regarding interstitial lung disease and addition of side effects in section 4.8
Updated on 24/12/2008 and displayed until 03/12/2009
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
Date of revision of text on the SPC:   01-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.4. Special warnings and special precautions for use

“Temporary suspension of atorvastatin may be appropriate during fusidic acid therapy (see Section 4.5)”


4.5. Interactions with other medicinal products and other forms of interaction

“Fusidic acid: Although interaction studies with atorvastatin and fusidic acid have not been conducted, severe

muscle problems such as rhabdomyolysis have been reported in post-marketing experience with this

combination. Patients should be closely monitored and temporary suspension of atorvastatin treatment may be appropriate.”

 

 

 
Updated on 14/11/2007 and displayed until 24/12/2008
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
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
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

4.2 Dosage information for use with interacting drugs

4.4 Warning text from the SPARCL study and updated warning text regarding  interacting drugs

4.5 Changes to the information relating to the possible interactions between atorvastatin and certain drugs, including Transport Inhibitors, Clarithromycin, Erythromycin, ciclosporin, Itraconazole, Diltiazem, ezetimide, Inducers of cytochrome P450 3A4, Verapamil and amiodarone.

4.8 Updated information on adverse events

5.1 Inclusion of clinical information from the SPARCL study
Updated on 07/11/2007 and displayed until 14/11/2007
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:   10/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

 

4.2 Dosage information for use with interacting drugs

4.4 Warning text from the SPARCL study and updated warning text regarding  interacting drugs

4.5 Changes to the information relating to the possible interactions between atorvastatin and certain drugs, including Transport Inhibitors, Clarithromycin, Erythromycin, ciclosporin, Itraconazole, Diltiazem, ezetimide, Inducers of cytochrome P450 3A4, Verapamil and amiodarone.

4.8 Updated information on adverse events

5.1 Inclusion of clinical information from the SPARCL study
Updated on 18/09/2007 and displayed until 07/11/2007
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:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 and 4.8 - Typing errors - Brackets were omitted.
Updated on 05/03/2007 and displayed until 18/09/2007
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Section 4.8 – addition of fatigue as an adverse event
Updated on 31/05/2006 and displayed until 05/03/2007
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 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   01/03/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Section 4.1
 
to include a new indication of primary prevention in Type II diabetes (based on the CARDS study).

Section 4.2

Inclusion of statement relating to dosage in the primary prevention studies.

03/2006Section 5.1

Inclusion of data from the primary prevention studies ASCOT LLA and CARDs.
Updated on 11/05/2006 and displayed until 31/05/2006
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 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   31/03/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

SmPC section 4.1

Update to the SmPC (section 4.1) to include a new indication of primary prevention in Type II diabetes (based on the CARDS study).

SmPC section 4.2

Inclusion of statement relating to dosage in the primary prevention studies.

SmPC section 5.1

Inclusion of data from the primary prevention studies ASCOT LLA and CARDs.
Updated on 18/04/2005 and displayed until 11/05/2006
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 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 02/02/2005 and displayed until 18/04/2005
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 18/01/2005 and displayed until 02/02/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 23/12/2004 and displayed until 18/01/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 10/11/2004 and displayed until 23/12/2004
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 08/11/2004 and displayed until 10/11/2004
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 15/08/2003 and displayed until 08/11/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 16/05/2003 and displayed until 15/08/2003
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
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 07/05/2003 and displayed until 16/05/2003
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
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 23/08/2001 and displayed until 07/05/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 22/08/2001 and displayed until 23/08/2001
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Updated on 22/08/2001 and displayed until 22/08/2001
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 06/09/2000 and displayed until 22/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 01/03/2000 and displayed until 06/09/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 17/02/2000 and displayed until 01/03/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 17/02/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  atorvastatin calcium trihydrate