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Folinic Acid (as Calcium Folinate) 15 mg Tablets

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Pharmacy Only: Prescription
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Updated on 05 December 2024

File name

Reg SPC gxFO 8_0 15mg tabs IE v16 04 Dec 24 Clean.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 3 Pharmaceutical Form – Tablet colour is described as ‘light yellow’.

Section 5.2 Pharmacokinetic properties – Minor typo.

SPC has also been consolidated with updates from IE gxFO 084, IE BV 082 (Grouped IAIN variation to change the MAH name and address [2024-0093088])


Updated on 17 October 2024

File name

Reg PIL gxFO 10_0 15mg tabs IE Clean.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

The PIL has been updated to reflect the SPC change for the MAH name and address.

Updated on 17 October 2024

File name

Reg SPC gxFO 7_0 15mg tabs IE Clean.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 Change of MAH name and address


Updated on 03 November 2023

File name

Reg SPC gx FO 50 15 mg tabs IE clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

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

Updated on 03 November 2023

File name

Reg PIL gx FO 90 15 mg tabs IE clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - driving and using machines
  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 03 November 2023

File name

Reg PIL gx FO 90 15 mg tabs IE clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - driving and using machines
  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 03 November 2023

File name

Reg PIL gx FO 90 15 mg tabs IE clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - driving and using machines
  • Change to section 6 - what the product contains
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to name of medicinal product

Updated on 22 August 2022

File name

Reg SPC gxFO 4_1 15mg tabs IE clean.pdf

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data

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

Updated on 03 March 2021

File name

DEC202114558_Reg PIL gxFO 8_0 15mg tabs IE - clean.pdf

Reasons for updating

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

Updated on 27 March 2020

File name

Reg SPC gxFO 3_2 15mg tabs IE-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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 and including QRD updates as follows:

Tabs: sections 2, 4.1, 4.2 (amended posology for megaloblastic anaemia), 4.3 (amended Pernicious anaemia or other anaemias contraindication and cross reference for use with methotrexate during pregnancy), 4.4 (added cytotoxic medicines, epileptic medicines, methotrexate and lactose warning), 4.5 (added folic acid antagonists, anti-epileptic substances, chloramphenicol), 4.6 (amended pregancy and breast-feeding and added fertility), 4.7, 4.8 (added neurological disorders), 4.9, 6.1, 6.3, 6.6, 10.

Updated on 27 March 2020

File name

Reg SPC gxFO 3_2 15mg tabs IE-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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

Tabs: sections 2, 4.1, 4.2 (amended posology for megaloblastic anaemia), 4.3 (amended Pernicious anaemia or other anaemias contraindication and cross reference for use with methotrexate during pregnancy), 4.4 (added cytotoxic medicines, epileptic medicines, methotrexate and lactose warning), 4.5 (added folic acid antagonists, anti-epileptic substances, chloramphenicol), 4.6 (amended pregancy and breast-feeding and added fertility), 4.7, 4.8 (added neurological disorders), 4.9, 6.1, 6.3, 6.6, 10.

Updated on 25 March 2020

File name

DEC202019081_Reg SPC gxFO 3_2 15mg tabs IE-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • 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 and including QRD updates as follows:

Tabs: sections 2, 4.1, 4.2 (amended posology for megaloblastic anaemia), 4.3 (amended Pernicious anaemia or other anaemias contraindication and cross reference for use with methotrexate during pregnancy), 4.4 (added cytotoxic medicines, epileptic medicines, methotrexate and lactose warning), 4.5 (added folic acid antagonists, anti-epileptic substances, chloramphenicol), 4.6 (amended pregancy and breast-feeding and added fertility), 4.7, 4.8 (added neurological disorders), 4.9, 6.1, 6.3, 6.6, 10.

Updated on 25 March 2020

File name

DEC202019081_Reg PIL gxFO 7_1 15mg tabs IE-clean.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 - 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 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 22 May 2019

File name

DEC201926542_Reg PIL gxFO 6_0 15mg tabs IE - clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 05 October 2018

File name

Reg PIL gxFO 4_0 15mg tabs IE - clean.pdf

Reasons for updating

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

Updated on 05 October 2018

File name

Reg SPC gxFO 2_0 15mg tabs IE - 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 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 14 September 2018

File name

Reg PIL gxFO 3_0 15mg tabs IE - clean.pdf

Reasons for updating

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

Updated on 18 August 2017

Reasons for updating

  • New SPC for new product

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

Updated on 17 August 2017

File name

PIL_17261_308.pdf

Reasons for updating

  • New PIL for new product

Pfizer Healthcare Ireland Unlimited Company

Pfizer Healthcare Ireland Unlimited Company