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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: 21/09/2010
SPC ACCURETIC 20/12.5MG 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 21/09/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01-Sep-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company
SmPC

Updates to sections 3 (Pharmaceutical form), 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 (Pregnancy and lactation), 4.7 (Effects on ability to drive and use machines),4.8 (Undesirable effects) , 5.2 (Pharmacokinetic properties), 6.1 (List of excipients) and 6.6 of the SPC.
Updated on 14/06/2007 and displayed until 21/09/2010
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • 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
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 

SECTIONS:

  1. Updated to include strength of each active and full Ph. Eur pharmaceutical form
  2. Updated to include excipients present in quantities exceeding threshold stated in EU guidance documents.
  3. Standard short term “tablet” added after EDQM recognised standard term and visual description and visual description of the product has been added.

6.1 Excipients have been updated in accordance with their Ph. Eur titles.

6.2 Text revised to standard sentence.

6.5 Standard sentence included

6.6 Amended to standard statement.
Updated on 01/07/2005 and displayed until 14/06/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder
Updated on 08/10/2003 and displayed until 01/07/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 27/06/2003 and displayed until 08/10/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Hydrochlorothiazide
  Quinapril hydrochloride