Inspra 25mg Film-Coated Tablets

  • Name:

    Inspra 25mg Film-Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Eplerenone

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/11/20

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Summary of Product Characteristics last updated on medicines.ie: 28/3/2017
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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 231 items.Total: Infinity pages

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 13 November 2020 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision
  • Joint PIL superseded by individual PILs

Updated on 26 April 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 6 November 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 March 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 28 March 2017 SPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

Approved changes are in line with Work sharing NL/H/xxxx/WS/189

The following changes to the labelling have been approved. Please refer to attached copies of labelling documentation for full details.

The SPC is updated in sections 4.2, 4.3, 4.5, 5.1, 5.2, 5.3 and editorial.

The PIL has been updated in section 2 and 4. See PIL tick list for sections updated.

The PI is affected.

The packaging (label/carton) are not affected

Implementation Responsibilities – Brand Marketing

SPC     Ireland Brand Marketing

Please implement in line with REG08-WI-IRL02 Generation and update of promotional material with regulatory license change

Affected

 

PI     Ireland Brand Marketing

Please implement in line with REG08-WI-IRL02 Generation and update of promotional material with regulatory license change

Affected

Updated on 28 March 2017 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

Approved changes are in line with Work sharing NL/H/xxxx/WS/189

The following changes to the labelling have been approved. Please refer to attached copies of labelling documentation for full details.

The SPC is updated in sections 4.2, 4.3, 4.5, 5.1, 5.2, 5.3 and editorial.

The PIL has been updated in section 2 and 4. See PIL tick list for sections updated.

The PI is affected.

The packaging (label/carton) are not affected

Implementation Responsibilities – Brand Marketing

SPC     Ireland Brand Marketing

Please implement in line with REG08-WI-IRL02 Generation and update of promotional material with regulatory license change

Affected

 

PI     Ireland Brand Marketing

Please implement in line with REG08-WI-IRL02 Generation and update of promotional material with regulatory license change

Affected

Updated on 3 November 2015 SPC

Reasons for updating

  • 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 SPC has been updated as Follow:

The SPC has been updated in section 4.8 to delete myocardial infarction

Updated on 3 November 2015 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

The SPC has been updated as Follow:

The SPC has been updated in section 4.8 to delete myocardial infarction

Updated on 27 January 2015 SPC

Reasons for updating

  • 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

Update to section 4.8, change of frequency of some side effects within the SOC and reporting information.

Updated on 27 January 2015 PIL

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Free text change information supplied by the pharmaceutical company

Update to section 4.8, change of frequency of some side effects within the SOC and reporting information.

Updated on 4 September 2013 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 5.2 - Pharmacokinetic properties

Free text change information supplied by the pharmaceutical company



section 4.2 to include statement on paediatric population

Section 4.3 ,4.5, 4.6, 4.8 update in line with QRD

Section 5.1 and 5.2 update on studies in paediatric population

Updated on 4 September 2013 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 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 to include statement on paediatric population

Section 4.3 ,4.5, 4.6, 4.8 update in line with QRD

Section 5.1 and 5.2 update on studies in paediatric population

Updated on 13 April 2012 PIL

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 4.7 - Effects on ability to drive and use machines
  • Change to section 5.1 - Pharmacodynamic properties

Free text change information supplied by the pharmaceutical company

Section 4.1 Therapeutic indications
Section 4.2 Posology and method of administration
Section 4.3 Contraindications
Section 4.4 Special warnings and precautions for use
Section 4.5 Interaction with other medicinal products and other forms of interaction
Section 4.7 Undesirable effects
Section 5.1 Pharmacodynamic properties

Updated on 13 April 2012 SPC

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 4.7 - Effects on ability to drive and use machines
  • 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

Section 4.1 Therapeutic indications
Section 4.2 Posology and method of administration
Section 4.3 Contraindications
Section 4.4 Special warnings and precautions for use
Section 4.5 Interaction with other medicinal products and other forms of interaction
Section 4.7 Undesirable effects
Section 5.1 Pharmacodynamic properties

Updated on 1 April 2010 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

Free text change information supplied by the pharmaceutical company

Section 2 was updated to include information about lactose

Updated on 1 April 2010 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

Section 2 was updated to include information about lactose

Updated on 28 February 2008 SPC

Reasons for updating

  • 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

 

4.8 –    Addition of a paragraph to provide further explanation as to the genesis of adverse events (i.e., from EPHESUS or from post marketing surveillance).

 

Reordering of some of the undesirable effects including with NO change to the information:

i)                    Infections and infestations

ii)                  Metabolism and nutrition disorders

iii)                Cardiac disorders

iv)                Vascular disorders

v)                  Gastrointestinal disorders

Updated on 28 February 2008 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

 

4.8 –    Addition of a paragraph to provide further explanation as to the genesis of adverse events (i.e., from EPHESUS or from post marketing surveillance).

 

Reordering of some of the undesirable effects including with NO change to the information:

i)                    Infections and infestations

ii)                  Metabolism and nutrition disorders

iii)                Cardiac disorders

iv)                Vascular disorders

v)                  Gastrointestinal disorders

Updated on 31 August 2006 PIL

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Free text change information supplied by the pharmaceutical company

Section 6.1 Excipients, 7 and 8 (Marketing authorisation holder and number

Updated on 31 August 2006 SPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

Section 6.1 Excipients, 7 and 8 (Marketing authorisation holder and number

Updated on 14 September 2005 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 14 September 2005 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Updated on 24 March 2005 SPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 24 March 2005 PIL

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Updated on 1 November 2004 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 1 November 2004 PIL

Reasons for updating

  • New SPC for new product