Methotrexate 10 mg Tablets *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *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 09 February 2021

File name

DEC202108365_Reg PIL gxME 10_0 10mg IE - clean_1612856946.pdf

Reasons for updating

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

Updated on 28 September 2020

File name

Reg SPC IE gxME 10_1 10mg-clean_1601284385.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 28 September 2020

File name

Reg PIL gxME 9_1 10mg IE-clean_1601284306.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 20 December 2019

File name

DEC201972132_Reg SPC IE gxME 9_2 10mg _clean_1576854322.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 December 2019

File name

DEC201972132_Reg PIL gxME 8_2 10mg IE_clean_1576854260.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision

Updated on 01 November 2018

File name

Reg PIL gxME 7_0 10mg IE_clean_1541060495.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects

Updated on 01 November 2018

File name

Reg SPC gxME 8_0 10mg IE_clean_1541060571.pdf

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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Please update eMC / medicines.ie

The SPC has been updated as per the PRAC recommendations. The following sections have been updated: 4.2, 4.3, 4.4, 4.5, 4.6, 4.8 and 4.9

 

Updated on 01 October 2018

File name

Reg SPC gxME 7_1 10mg IE_clean_1538141110_1538391507.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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 7 has been updated from Current MAH 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 28 September 2018

File name

Reg PIL gxME 6_1 10mg IE_clean_1538141835.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 28 September 2018

File name

Reg SPC gxME 7_1 10mg IE_clean_1538141110.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 7 has been updated from Current MAH 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 09 August 2018

File name

Reg SPC gxME 6_0 10mg IE_clean_1533803277.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC impacted only.

Section 4.4 – updated to include reference to Thoracic pain.

Updated on 01 May 2018

File name

Reg_SPC_gxME_4_0_10mg_IE_clean.docx

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Please update eMC / medicines.ie

Section 4.4 and 4.8 updates with details of pulmonary alveolar haemorrhage

Section 10-  update date of revision of text to 04/2018 to reflect submission date and internal reference number updated.

 

Updated on 23 April 2018

File name

Reg PIL gxME 4_0 10mg IE_clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 07 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 07 December 2017

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 4.8 - Undesirable effects
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated to align with Orion CSI. The following sections are updated:

Sections 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 6.6 and  10

Updated on 05 December 2017

Reasons for updating

  • 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 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation holder

Updated on 05 December 2017

File name

PIL_17034_675.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 July 2017

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The change to the MAH address from Leamington to Hurley and the change of address for the batch release site have been implemented, that is the artwork has been signed off for production.

Updated on 26 July 2017

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - marketing authorisation holder

Updated on 04 July 2017

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

HPRA on 17 May 2017 was approved for Methotrexate 2.5mg and 10mg tablets.

This submission included modifications to the SPC and consequently PIL to include details of methotrexate and nitrous oxide interaction. This was approved with

no deficiencies.

Updated on 29 June 2017

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision

Updated on 05 January 2017

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 04 January 2017

Reasons for updating

  • New PIL for medicines.ie