Istin 10mg Tablets
- Name:
Istin 10mg 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
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 5/10/2020
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Pfizer Healthcare Ireland
Company Products
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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
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
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
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
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 21 March 2018 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 24 January 2018
Reasons for updating
- New SmPC 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 SPC has been updated as follows: The following amendments have been made to the SmPCs in line with PRAC wording endorsed by the CMDh:
• 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.
• 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 23 January 2018 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
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
The SPC wording in section 4.5 has been updated as follows;
“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.”
“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 December 2017 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to other sources of information section
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
The SPC has been updated following a new publication about amlodipine excretion into human breast-milk.
Updated on 20 June 2017 PIL
Reasons for updating
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 6 - date of revision
Updated on 12 February 2016 PIL
Reasons for updating
- Change to packaging
- Change to side-effects
- Change to date of revision
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 9 April 2015 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
- Change of distributor details
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 10 February 2015 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to further information section
- Change to date of revision
- Change of special precautions for disposal
Updated on 28 October 2014 PIL
Reasons for updating
- Change to product name
- Removal/change of distributor
Updated on 2 October 2014 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
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
Update to sections 6.1 and 6.5 of SPC due to Renewal Application
Updated on 5 September 2013 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
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
Sections 6.1 and 6.5
Updated on 13 August 2013 PIL
Reasons for updating
- Improved electronic presentation
Updated on 3 July 2013 PIL
Reasons for updating
- Improved electronic presentation
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
Change to Section 5.2
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
Update to section 6 to amend excipients names as per CMS comments
Updated on 15 February 2013 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 7 January 2013 SPC
Reasons for updating
- Change to separate SPCs covering individual presentations
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Change to seperate SPC covering individual presentations
Updated on 7 September 2012 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
- Change to dosage and administration
Updated on 18 July 2012 SPC
Reasons for updating
- SPC Product / presentation discontinued
- 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
Updates to section 4.5 (interactions) of the SPC
Updated on 12 July 2012 PIL
Reasons for updating
- Change of contraindications
- Change to date of revision
Updated on 19 December 2011 PIL
Reasons for updating
- Improved electronic presentation
Updated on 25 November 2011 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 14 November 2011 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- 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 4.7 - Effects on ability to drive and use machines
- 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
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Updates to sections 2 (Qualitative
and quantitative composition); 3 ( Pharmaceutical form) ; 4.2( Posology and
method of administration) ; 4.3 (Contraindications), 4.4 (Special
warnings and precautions for use), 4.5 (Interaction with other medicinal
products and other forms of interaction), 4.6 ( Fertility, Pregnancy and
lactation) 4.7 ( effects on ability to drive and use machines) 4;.8
(Undesirable effects) 4.9 (Overdose) 5.1 Pharmacodynamics 5.2 Pharmacokinetic
properties ; 5.3 (preclinical safety data ) 6.1 (List of excipients) 6.5 (
nature and contents of container ) 6.6 (instructions for use and handling ) 10
(date of revision of the text ).
Updated on 10 November 2011 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about missed dose
- Change to instructions about overdose
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to further information section
- Change to date of revision
- Change to dosage and administration
Updated on 8 July 2011 SPC
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
- 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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 4.2 (Posology and method of administration); 4.3 (Contraindications); 4.4 (Special warnings and precautions for use); 4.5 (Interactions with other medicinal products and other forms of interaction); 4.6 (Fertility, pregnancy and lactation); 4.7 (Effects on ability to drive and use machines); 4.8 (Undesirable effects); 4.9 (Overdose); 5.1 (pharmacodynamic properties); 5.2 (Pharmacokinetic properties)
Updated on 7 July 2011 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
- Change to dosage and administration
- Change to MA holder contact details
- Changes to therapeutic indications
Updated on 4 July 2011 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- Change to section 6.2 - Incompatibilities
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SmPC Updates to section 2 (Qualitative and Quantitative composition); section 3 (Pharmaceutical form); section 6.1 (List of excipients); section 6.2 (Incompatibilities)
Updated on 23 February 2010 PIL
Reasons for updating
- Change of inactive ingredient
- Change to date of revision
Updated on 10 June 2009 PIL
Reasons for updating
- Correction of spelling/typing errors
Updated on 27 May 2009 PIL
Reasons for updating
- Change due to user-testing of patient information
Updated on 27 November 2008 PIL
Reasons for updating
- Correction of spelling/typing errors
- Change to name of manufacturer
Updated on 7 July 2008 SPC
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
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
updates to sections 4.3 (Contra-indications), 4.4 (Special warnings) and 4.6 (pregnancy and lactation)
Updated on 25 September 2007 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
Section 4.5 - change BAN, 'cylosporin' to INN 'ciclosporin'
Updated on 19 December 2005 PIL
Reasons for updating
- Change of active ingredient
- Change to appearance of the medicine
- Change of manufacturer
- Change to side-effects
- Change to further information section
Updated on 12 December 2005 SPC
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 6.1 - List of excipients
- 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 April 2005 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 1 February 2005 PIL
Reasons for updating
- Change to storage instructions
Updated on 31 January 2005 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 25 January 2005 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to drug interactions
- Change to storage instructions
Updated on 24 January 2005 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 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 21 December 2004 PIL
Reasons for updating
- Change to storage instructions
Updated on 9 December 2004 SPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 16 September 2004 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 1 September 2004 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.2 - Incompatibilities
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 16 August 2004 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 27 June 2003 SPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)