Accupro 5 mg Film - Coated tablets

Product Information *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Active Ingredients * :

    *Additional information is available upon request

  • Legal Category:

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

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

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

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 13 September 2017

Reasons for updating

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

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

Reasons for updating

  • New PIL for new product

Updated on 18 August 2017

Reasons for 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

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 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 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 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

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 03 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

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 03 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 12 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 5.1 - Pharmacodynamic properties

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 12 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 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 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

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 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

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 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 28 February 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

Section 4.2 (Information on the posology of paediatric patients).

Section 5.1 (additional information on clinical trial studies)

Section 5.2 (information on pharmacokinetic studies in children)

Updated on 28 February 2013

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

Section 4.2 (Information on the posology of paediatric patients).

Section 5.1 (additional information on clinical trial studies)

Section 5.2 (information on pharmacokinetic studies in children)

Updated on 04 May 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form

Free text change information supplied by the pharmaceutical company

Section 2 –Wording updated to include information on the quantities of the excipients   and to also include the wording “For a full list of excipients see section, 6.1.”

Section 3-To change the descriptive wording of the Film-Coated Tablets, and to also include the wording    “The scoreline is to allow breaking for ease of swallowing and not to divide into equal halves.”

Updated on 04 May 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Section 2 –Wording updated to include information on the quantities of the excipients   and to also include the wording “For a full list of excipients see section, 6.1.”

Section 3-To change the descriptive wording of the Film-Coated Tablets, and to also include the wording    “The scoreline is to allow breaking for ease of swallowing and not to divide into equal halves.”

Updated on 18 March 2010

Reasons for 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
  • Change to section 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company

Update to sections 4.3, 4.4, 4.6 and 5.2 of the SPC with the Pharmacovgilance Working Party wording relating to the use of ACE inhibitors during pregnancy and lactation.

Updated on 18 March 2010

Reasons for 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
  • 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

Update to sections 4.3, 4.4, 4.6 and 5.2 of the SPC with the Pharmacovgilance Working Party wording relating to the use of ACE inhibitors during pregnancy and lactation.

Updated on 31 August 2006

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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

Free text change information supplied by the pharmaceutical company

Section 3
 
appearance of tablet changed from: 'brown film coated elliptical tablets imprinted with the dosage strength 40 mg' 
 
TO 'reddish-brown, oval biconvex film-coated tablet with debossing '40' on one side and 'PD 535' on the other side.'

Updated on 31 August 2006

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Free text change information supplied by the pharmaceutical company

Section 3
 
appearance of tablet changed from: 'brown film coated elliptical tablets imprinted with the dosage strength 40 mg' 
 
TO 'reddish-brown, oval biconvex film-coated tablet with debossing '40' on one side and 'PD 535' on the other side.'

Updated on 01 July 2005

Reasons for 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

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

Updated on 01 July 2005

Reasons for 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 15 March 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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

Updated on 15 March 2005

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Updated on 06 October 2003

Reasons for 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 06 October 2003

Reasons for 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

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

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

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

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie