Accupro 5 mg Film - Coated tablets * Pharmacy Only: Prescription
Company:
Pfizer Healthcare IrelandStatus:
UpdatedLegal 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
Updated on 26 July 2022
File name
62e00fc7bddb2.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to Section 4.8 – Undesirable effects - how to report a side effect
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 3 of the SPCs for 5 mg, 10 mg and 20 mg tablets updated to state that the tablet can be divided into equal doses. Section 3 of the SPC for 40 mg tablets was updated to delete the statement that the score line is only to facilitate breaking for ease of swallowing and not to divide into equal halves, this is because the 40 mg tablet does not have a score line. Section 4.8 of the SPCs has been updated with latest details for reporting adverse events.
Updated on 26 July 2022
File name
62e00f6f1fc16.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 04 April 2022
File name
RegSPCAC5mg230IEclean_1649091463.pdf
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
The SPCs have been updated as follows:
Information on Syndrome of inappropriate hormone secretion (SIADH), and hyponatremia in sections 4.4 and 4.8 and the information on Psoriasis has been updated in section 4.8.
Updated on 04 April 2022
File name
RegPILAC290IEclean_1649091377.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 28 August 2018
File name
Reg PIL AC 27_2 IE cl_1535464084.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 5mg 21_2 IE cl_1535466478.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
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
Updated on 11 September 2017
File name
PIL_8902_750.pdf
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
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 inhibitorsUpdated 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 inhibitorsUpdated 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
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 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 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 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 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 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
Free text change information supplied by the pharmaceutical company
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
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
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 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 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 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 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 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 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
Updated on 31 August 2006
Reasons for updating
- Change to section 3 - Pharmaceutical form
Free text change information supplied by the pharmaceutical company
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
Legal category:Product subject to medical prescription which may be renewed (B)
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 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