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Pfizer Healthcare Ireland
9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Summary of Product Characteristics last updated on medicines.ie: 14/11/2011
SPC Istin 5mg & 10mg 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 14/11/2011 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 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   31-Oct-2011
Legal Category:   Product subject to restricted prescription (C)

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 08/07/2011 and displayed until 14/11/2011
Reasons for adding or updating:
  • 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
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
Sections 4.2 (Posology and method of administration); 4.3 (Contraindications); 4.4 (Special warnings and precautions for use); 4.5 (Interactions 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 (pharmacodynamic properties); 5.2 (Pharmacokinetic properties)
Updated on 04/07/2011 and displayed until 08/07/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
SmPC Updates to section 2 (Qualitative and Quantitative composition); section 3 (Pharmaceutical form); section 6.1 (List of excipients); section 6.2 (Incompatibilities)
Updated on 07/07/2008 and displayed until 04/07/2011
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 4.6 - Pregnancy and lactation
Date of revision of text on the SPC:   06/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

updates to sections 4.3 (Contra-indications), 4.4 (Special warnings) and 4.6 (pregnancy and lactation)
Updated on 25/09/2007 and displayed until 07/07/2008
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:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 4.5 - change BAN, 'cylosporin' to INN 'ciclosporin'
Updated on 12/12/2005 and displayed until 25/09/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Updated on 15/04/2005 and displayed until 12/12/2005
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Updated on 31/01/2005 and displayed until 15/04/2005
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
Updated on 24/01/2005 and displayed until 31/01/2005
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
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
Updated on 09/12/2004 and displayed until 24/01/2005
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
Updated on 01/09/2004 and displayed until 09/12/2004
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 16/08/2004 and displayed until 01/09/2004
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Updated on 27/06/2003 and displayed until 16/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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