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Istin 10mg Tablets

*
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Amlodipine Besilate

    *Additional information is available within the SPC or upon request to the company

Updated on 09 May 2024

File name

Patient Information Leaflet Istin - 002906631 - clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 26 October 2023

File name

Patient Information Leaflet - IE - Istin tabs - tradedress tablet marking.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to appearance of the medicine

Updated on 26 October 2023

File name

Patient Information Leaflet - IE - Istin tabs - tradedress tablet marking.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to appearance of the medicine

Updated on 26 October 2023

File name

SmPC - IE - Istin 10mg tablets - tradedress tablet marking.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

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

Updated on 26 October 2023

File name

SmPC - IE - Istin 10mg tablets - tradedress tablet marking.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

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

Updated on 26 October 2023

File name

SmPC - IE - Istin 10mg tablets - tradedress tablet marking.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

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

Updated on 26 October 2023

File name

SmPC - IE - Istin 10mg tablets - tradedress tablet marking.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 - Date of revision of the text

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

Updated on 23 January 2023

File name

Patient Information Leaflet - Istin tabs IE - UK IE IS 212.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 15 July 2022

File name

Reg SPC 10mg tablets IS 33_1 - clean.pdf

Reasons for updating

  • Change to section 4.9 - Overdose

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 4.9 Overdose – PRAC update

Updated on 04 July 2022

File name

DEC202207844-V_Reg SPC 10mg tablets IS 33_0 -clean.pdf

Reasons for updating

  • Change to section 4.9 - Overdose

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 4.9 Overdose – PRAC update

Updated on 04 July 2022

File name

DEC202207844-V_Reg PIL 5mg 10mg tablets IS 40_0- clean.pdf

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 31 August 2021

File name

DEC202111336-V_Reg PIL 5mg & 10mg tablets IS 39_2 - clean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 13 July 2021

File name

DEC202109397-V_Reg SPC 10mg tablets IS 32_1 - clean.pdf

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)

Updated on 13 July 2021

File name

DEC202109397-V_Reg PIL 5mg & 10mg tablets IS 37_1 - clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 05 October 2020

File name

DEC202047738-V_Reg SPC 10mg tablets IS 31_2.Clean.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 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 05 October 2020

File name

DEC202047738-V_Reg PIL 5mg & 10mg tablets IS 36_2.Clean.pdf

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 02 August 2018

File name

Reg PIL 5mg & 10mg tablets IS 35_0_1.Clean.pdf

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 02 August 2018

File name

Reg SPC 10mg tablets IS 30_0.Clean.pdf

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

File name

PIL_8756_430.pdf

Reasons for updating

  • New PIL for new product

Updated on 21 March 2018

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 24 January 2018

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

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.

Updated on 23 January 2018

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Updated on 02 January 2018

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.”

Updated on 21 December 2017

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

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

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 12 February 2016

Reasons for updating

  • Change to packaging
  • Change to side-effects
  • Change to date of revision

Updated on 13 April 2015

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 09 April 2015

Reasons for updating

  • Change to drug interactions
  • Change to date of revision
  • Change of distributor details

Updated on 11 February 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 4.6 - 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

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

Reasons for updating

  • Change to product name
  • Removal/change of distributor

Updated on 02 October 2014

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 10 September 2013

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 05 September 2013

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 16 August 2013

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

Reasons for updating

  • Improved electronic presentation

Updated on 03 July 2013

Reasons for updating

  • Improved electronic presentation

Updated on 07 May 2013

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

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

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 07 January 2013

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 07 September 2012

Reasons for updating

  • Change to further information section
  • Change to date of revision
  • Change to dosage and administration

Updated on 18 July 2012

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

Reasons for updating

  • Change of contraindications
  • Change to date of revision

Updated on 19 December 2011

Reasons for updating

  • Improved electronic presentation

Updated on 25 November 2011

Reasons for updating

  • Correction of spelling/typing errors

Updated on 14 November 2011

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

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 08 July 2011

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 07 July 2011

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 04 July 2011

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

Reasons for updating

  • Change of inactive ingredient
  • Change to date of revision

Updated on 10 June 2009

Reasons for updating

  • Correction of spelling/typing errors

Updated on 27 May 2009

Reasons for updating

  • Change due to user-testing of patient information

Updated on 27 November 2008

Reasons for updating

  • Correction of spelling/typing errors
  • Change to name of manufacturer

Updated on 07 July 2008

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

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

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

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

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

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

Updated on 01 February 2005

Reasons for updating

  • Change to storage instructions

Updated on 31 January 2005

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

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

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

Reasons for updating

  • Change to storage instructions

Updated on 09 December 2004

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

Reasons for updating

  • New PIL for medicines.ie

Updated on 01 September 2004

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

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

Reasons for updating

  • New SPC for medicines.ie

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