Accupro 10 mg Film - Coated tablets *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, 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 28 August 2018

File name

Reg PIL AC 27_2 IE cl_1535463689.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 28 August 2018

File name

Reg SPC AC 10mg 21_2 IE cl_1535466150.pdf

Reasons for 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 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text

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:

QRD update  SPC sections: 1/2/3/4.1/4.2/4.3/4.4/4.5/4.6/4.8/5.1/6.1/6.2/6.4/6.6/9/10.

Updated on 13 September 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 13 September 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 & 4.8 have been updated to add warning about hyponatraemia and Syndrome of Inappropriate Anti-diuretic Hormone (SIADH).

Updated on 11 September 2017

File name

PIL_8902_750.pdf

Reasons for updating

  • New PIL for new product

Updated on 11 September 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 22 August 2017

Reasons for 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

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:

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 18 August 2017

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 17 November 2015

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 17 November 2015

Reasons for 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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:

·         Updating the text related to the existing warning concerning hyperkalaemia under Section 4.4, Special warnings and precautions for use.

·         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 04 August 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

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:

Section 2 - formatting update

Section 3 - formatting update

Section 4.3 - updated to include “Accupro is contraindicated in patients with hypersensitivity to the active substance or any of the excipients listed in section 6.1.”

Section 4.4 - updated to include warning to exercise caution when starting an mTOR inhibitor or a DPP-IV inhibitor in a patient already taking an ACE inhibitor.

Section 4.5 - updated in line with warning in  section 4.4 (above) and additionally with warning not to co-administer aliskiren with quinapril in patients with diabetes or in patients with renal impairment.

Updated on 31 July 2015

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 02 April 2015

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 08 January 2015

Reasons for 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

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:

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 05 January 2015

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to date of revision

Updated on 02 July 2013

Reasons for 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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.5 : NSAID-ACE inhibitor interaction wording has been added  
Section 10 Date of revision

Updated on 06 June 2013

Reasons for 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
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.3 : Contraindications; Section 4.4 Special warnings ; Section 4.5 Interactions ; Section 4,8 Undesirable effects ; Section 10 Date of revision

Updated on 04 June 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration

Updated on 27 February 2013

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 09 March 2010

Reasons for updating

  • Change to information about pregnancy or lactation

Updated on 07 October 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 19 June 2009

Reasons for updating

  • Change to date of revision
  • Change of manufacturer

Updated on 26 February 2008

Reasons for updating

  • Change to name of manufacturer

Updated on 13 April 2007

Reasons for updating

  • Change to date of revision

Updated on 31 August 2006

Reasons for updating

  • Change to appearance of the medicine

Updated on 04 July 2005

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to marketing authorisation holder

Updated on 16 March 2005

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 17 September 2004

Reasons for updating

  • New PIL for medicines.ie