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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: 15/11/2011
SPC Istin

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 15/11/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Oct-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Updates to sections  2 (Qualitative and quantitative composition); 3 ( Pharmaceutical form) ; 4.2( Posology and method of administration) ; 4.3 (Contraindications), 4.4 (Special warnings and precautions for use), 4.5 (Interaction with other medicinal products and other forms of interaction), 4.6 ( Fertility, Pregnancy and lactation)  4.7 ( effects on ability to drive and use machines) 4;.8 (Undesirable effects) 4.9 (Overdose) 5.1 Pharmacodynamics 5.2 Pharmacokinetic properties ; 5.3 (preclinical safety data ) 6.1 (List of excipients) 6.5 ( nature and contents of container ) 6.6 (instructions for use and handling ) 10 (date of revision of the text ).

 
Updated on 01/04/2010 and displayed until 15/11/2011
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   22-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.5 – Updated to include the potential for interactions to occur in relation to the consumption of grapefruit/grapefruit juice

Section 10 (date of revision of the text) – Updated as a consequence of the above
Updated on 02/02/2010 and displayed until 01/04/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   01-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 – Updated to include recommended dosing for children

Section 5.1 and 5.2 – Updated to provide information on paediatric studies
Updated on 02/08/2007 and displayed until 02/02/2010
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:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.5 – BANs to INNs, Indomethacin to Indometacin and Cyclosporin to Ciclosporin

PIL
Updated on 18/01/2006 and displayed until 02/08/2007
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/01/2006 and displayed until 18/01/2006
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 10 (date of (partial) revision of the text
Updated on 31/08/2005 and displayed until 17/01/2006
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 (date of (partial) revision of the text
Updated on 12/04/2005 and displayed until 31/08/2005
Reasons for adding or updating:
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Updated on 31/01/2005 and displayed until 12/04/2005
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 31/01/2005 and displayed until 31/01/2005
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Pending awaiting re-submission
Updated on 27/10/2004 and displayed until 31/01/2005
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • 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
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 23/08/2001 and displayed until 27/10/2004
Reasons for adding or updating:
  • No reasons supplied
Updated on 03/10/2000 and displayed until 23/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/07/2000 and displayed until 03/10/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 06/07/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  amlodipine besilate