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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: 23/08/2017
SPC Accuretic 20 mg/12.5 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 23/08/2017 and displayed until Current
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 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-Aug-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.3, 4.4 and 4.5 have been updated in relation to the risk of angioedema when ACE inhibitors are used in combination with NEP inhibitors.
Updated on 19/11/2015 and displayed until 23/08/2017
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 - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   01-Nov-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:

·         Addition of text related to a drug interaction between the class of angiotensin converting enzyme inhibitors (ACEis) and co-trimoxazole under Section 4.5, Interaction with other medicinal products and other forms of interaction.

·         In addition a number of minor formatting and grammatical amendments were made to sections 2, 4.2, 4.3, 4.4, 4.5, 4.6, 4.9, 5.1 and 5.2 of the SPC.

Updated on 11/02/2015 and displayed until 19/11/2015
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 4.3 - 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
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



Section 4.1  Therapeutic indications updated with cross reference to “see sections 4.3, 4.4, 4.5 and 5.1”.

Section 4.2  Posology and method of administration updated with cross reference to “see sections 4.3, 4.4, 4.5 and 5.1”.

Section 4.3  Contraindication updated to include concomitant use of Accupro with aliskiren-containing products in patients with diabetes mellitus or renal impairment.

Section 4.4  Special warnings and precautions updated to include warning that Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is not recommended

Section 4.5 Interaction with other medicinal products and other forms of interaction updated to include information that dual blockade of the RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events.

Section 4.8 Updated to include information on Reporting of suspected ADRs

Section 5.1  Pharmacodynamic properties updated to include clinical trial data showing no significant beneficial effect of the combination of an ACE-inhibitor with an angiotensin II receptor blocker
Updated on 15/01/2014 and displayed until 11/02/2015
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 4.7 - 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 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01-Jan-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update to Section 2, 4.2, 4.3, 4.4,4.5, 4.6, 4.7,4.8, 4.9, 5.1, 5.2 & 6.6
Updated on 28/08/2013 and displayed until 15/01/2014
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 10 - Date of revision of the text
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



section 4.4 of the CDS, information in relation to ‘Acute Myopia and Secondary Angle-Closure Glaucoma’ has been updated.

sections  4.5 and 4.6 - update to title
Updated on 21/09/2010 and displayed until 28/08/2013
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