Istin 5mg Tablets
- Name:
Istin 5mg 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: 05/10/20
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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 5 October 2020 SPC
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 SPC has been updated as follows : Sections 4.4 insertion: Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’ & Section 4.8: Insertion of ‘not known’ undesirable effect ‘Extrapyramidal disorder’.
Updated on 5 October 2020 PIL
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Change to other sources of information section
Updated on 2 August 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - date of revision
Updated on 2 August 2018 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
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 7 has been updated from Current MAH Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK to Pfizer Healthcare Ireland, 9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24, Ireland. Subsequently section 8 has also been updated with the HPRA newly appointed Marketing Authorisation number.
Updated on 21 March 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 24 January 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 24 January 2018 SPC
Reasons for updating
- 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
• The wording regarding co-administration of amlodipine and strong CYP3A4 inducers has been revised in Section 4.5 of the SmPCs. The wording in Section 2 of the PILs is already in compliance with the PRAC wording and therefore no further updates are required.
• An update to Section 4.6 of the SmPCs to include the proportion of maternal dose received by infant during lactation with a consequential update to Section 2 of the PILs.
• The adverse event, Toxic epidermal necrolysis (TEN) has been added to Section 4.8 of the SmPCs with a frequency of “not known” with a consequential update to Section 4 of the PILs.
Updated on 24 January 2018 PIL
Reasons for updating
- 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
Free text change information supplied by the pharmaceutical company
• The wording regarding co-administration of amlodipine and strong CYP3A4 inducers has been revised in Section 4.5 of the SmPCs. The wording in Section 2 of the PILs is already in compliance with the PRAC wording and therefore no further updates are required.
• An update to Section 4.6 of the SmPCs to include the proportion of maternal dose received by infant during lactation with a consequential update to Section 2 of the PILs.
• The adverse event, Toxic epidermal necrolysis (TEN) has been added to Section 4.8 of the SmPCs with a frequency of “not known” with a consequential update to Section 4 of the PILs.
Updated on 2 January 2018 SPC
Reasons for updating
- 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
“Mechanistic Target of Rapamycin (mTOR) Inhibitors
mTOR inhibitors such as sirolimus, temsirolimus, and everolimus are CYP3A substrates. Amlodipine is a weak CYP3A inhibitor. With concomitant use of mTOR inhibitors, amlodipine may increase exposure of mTOR inhibitors.”
Updated on 2 January 2018 PIL
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Free text change information supplied by the pharmaceutical company
“Mechanistic Target of Rapamycin (mTOR) Inhibitors
mTOR inhibitors such as sirolimus, temsirolimus, and everolimus are CYP3A substrates. Amlodipine is a weak CYP3A inhibitor. With concomitant use of mTOR inhibitors, amlodipine may increase exposure of mTOR inhibitors.”
Updated on 21 June 2017 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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 21 June 2017 PIL
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 13 April 2015 SPC
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
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
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. Update section 4.5 to include interaction with tacrolimus and minor administrative/typographical corrections including minimal updates following QRDv. 9 section 4.4, 4.8, 5.2.6.4
Updated on 13 April 2015 PIL
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
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.4 - Special precautions for storage
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows. Update section 4.5 to include interaction with tacrolimus and minor administrative/typographical corrections including minimal updates following QRDv. 9 section 4.4, 4.8, 5.2.6.4
Updated on 11 February 2015 SPC
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
The SPC has been updated as follows.
UK/H/xxx/WS48 to update section 4.5 (interactions) of the SPC, in line with the CDS to include the findings of a literature review for interaction with cyclosporine. The SPC has also been updated in line with the QRD template sections 2,4.2,4.3,4.4,4,6,4.9, 5.1, 5.2,5.3. As a consequence, the PIL has been updated, cartons have also been updated to reflect spc change to “keep out of the sight and reach of children.
UK/H/xxx/WS61 to update section 4.8 (undesirable effects) of the SPC to reflect a review of the clinical trial data used to assess the estimated frequencies of ADRs reported.Updated on 11 February 2015 PIL
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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
The SPC has been updated as follows.
UK/H/xxx/WS48 to update section 4.5 (interactions) of the SPC, in line with the CDS to include the findings of a literature review for interaction with cyclosporine. The SPC has also been updated in line with the QRD template sections 2,4.2,4.3,4.4,4,6,4.9, 5.1, 5.2,5.3. As a consequence, the PIL has been updated, cartons have also been updated to reflect spc change to “keep out of the sight and reach of children.
UK/H/xxx/WS61 to update section 4.8 (undesirable effects) of the SPC to reflect a review of the clinical trial data used to assess the estimated frequencies of ADRs reported.Updated on 10 September 2013 PIL
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Free text change information supplied by the pharmaceutical company
Updated on 10 September 2013 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 August 2013 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Improved electronic presentation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 16 August 2013 PIL
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Improved electronic presentation
Free text change information supplied by the pharmaceutical company
Updated on 7 May 2013 PIL
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Free text change information supplied by the pharmaceutical company
Updated on 7 May 2013 SPC
Reasons for updating
- 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
Updated on 15 February 2013 SPC
Reasons for updating
- Change to section 6.1 - List of excipients
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 15 February 2013 PIL
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Updated on 10 September 2012 SPC
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
Update to sections 3 (Pharmaceutical form) and 4.2 (Posology and method of administration) providing breakability data for amlodipine 5 mg tablets to support the SmPC and Patient Leaflet claim that the 5 mg scored tablet can be divided into equal halves allowing a 2.5 mg dose. This application fulfils a Letter of Undertaking provided to CHMP during the Norvasc and associated names Article 30 Referral procedure EMA/H/A-30/1288 and with the agreement of the RMS.
Updated on 10 September 2012 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
Update to sections 3 (Pharmaceutical form) and 4.2 (Posology and method of administration) providing breakability data for amlodipine 5 mg tablets to support the SmPC and Patient Leaflet claim that the 5 mg scored tablet can be divided into equal halves allowing a 2.5 mg dose. This application fulfils a Letter of Undertaking provided to CHMP during the Norvasc and associated names Article 30 Referral procedure EMA/H/A-30/1288 and with the agreement of the RMS.