Inspra 25mg Film-Coated Tablets
- Name:
Inspra 25mg Film-Coated Tablets
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- 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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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Pfizer Healthcare Ireland
Company Products
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- Joint PIL superseded by individual PILs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 SPC
Reasons for updating
- New SPC 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
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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. |
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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
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
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 4.2 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 4.2 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
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
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
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
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