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Amlodipine Pfizer 5 mg Tablets *
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    Updated

  • 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

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 23 November 2021

File name

DEC202114817-V_Reg SPC 5mg tablets dxAML 14_2 - clean_1637651873.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address

Section 8 - updated with new PA number for Upjohn EESV

In addition IE BV 078 Pfizer Name Change updates are included;

Section 1, 4.2 & 5.1 - 'Amlodipine Pfizer' changed to 'Amlodipine Upjohn'

Section 4.8 - Update to HPRA ADR reporting details

Updated on 17 November 2021

File name

DEC202114817-V_Reg SPC 5mg tablets dxAML 14_2 - clean_1637159830.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 - Pfizer Healthcare Ireland changed to Upjohn EESV as the MAH, with updated address

Section 8 - updated with new PA number for Upjohn EESV

Updated on 17 November 2021

File name

DEC202114817-V_Reg PIL 5mg & 10mg tablets dxAML 21_0 - clean_1637159793.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 02 August 2018

File name

Reg PIL 5mg & 10mg tablets dxAML 17_0_1.Clean_1533193542.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 5mg tablets dxAML 12_0.Clean_1533193578.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_15427_241.pdf

Reasons for updating

  • New PIL for new product

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 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

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 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 02 January 2018

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

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 20 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 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

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 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

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

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 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 4.5 - 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 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

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 4.5 - 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 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

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

An update to sections 6.1 and 6.5 of the SPC in line with Renewal Application

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

Free text change information supplied by the pharmaceutical company

An update to sections 6.1 and 6.5 of the SPC in line with Renewal Application

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

The changes described below to Sections 6.1 and 6.5

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

Free text change information supplied by the pharmaceutical company

The changes described below to Sections 6.1 and 6.5

Updated on 19 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 19 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

Free text change information supplied by the pharmaceutical company

Update to section 6 to amend excipients names as per CMS comments

Updated on 10 September 2012

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.

Updated on 10 September 2012

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.