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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
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 20/06/2017
SPC Amlodipine Pfizer 5 mg 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 20/06/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jun-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

The SPC has been updated following a new publication about amlodipine excretion into human breast-milk.
Updated on 13/04/2015 and displayed until 20/06/2017
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 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   01-Apr-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows. Update section 4.5 to include interaction with tacrolimus and minor administrative/typographical corrections including minimal updates following QRDv. 9 section 4.4, 4.8, 5.2.6.4

Updated on 11/02/2015 and displayed until 13/04/2015
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - 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
Date of revision of text on the SPC:   01-Feb-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows.

UK/H/xxx/WS48 to update section 4.5 (interactions) of the SPC, in line with the CDS to include the findings of a literature review for interaction with cyclosporine. The SPC has also been updated in line with the QRD template sections 2,4.2,4.3,4.4,4,6,4.9, 5.1, 5.2,5.3. As a consequence, the PIL has been updated, cartons have also been updated to reflect spc change to “keep out of the sight and reach of children.

UK/H/xxx/WS61 to update section 4.8 (undesirable effects) of the SPC to reflect a review of the clinical trial data used to assess the estimated frequencies of ADRs reported. 
Updated on 10/09/2013 and displayed until 11/02/2015
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Aug-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

An update to sections 6.1 and 6.5 of the SPC in line with Renewal Application
Updated on 16/08/2013 and displayed until 10/09/2013
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Improved electronic presentation
Date of revision of text on the SPC:   01-Jul-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

The changes described below to Sections 6.1 and 6.5
Updated on 19/02/2013 and displayed until 16/08/2013
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Feb-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update to section 6 to amend excipients names as per CMS comments
Updated on 10/09/2012 and displayed until 19/02/2013
Reasons for adding or updating:
  • New individual SPC (was previously included in combined SPC)
Date of revision of text on the SPC:  
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update to sections 3 (Pharmaceutical form) and 4.2 (Posology and method of administration) providing breakability data for amlodipine 5 mg tablets to support the SmPC and Patient Leaflet claim that the 5 mg scored tablet can be divided into equal halves allowing a 2.5 mg dose. This application fulfils a Letter of Undertaking provided to CHMP during the Norvasc and associated names Article 30 Referral procedure EMA/H/A-30/1288 and with the agreement of the RMS.

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Active Ingredients

 
   Amlodipine besilate