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Solu-Cortef Powder for Solution for Injection or Infusion 100 mg

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Pharmacy Only: Prescription

Updated on 26 September 2023

File name

RegSPCSC181IEclean.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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.4: Addition of warning on Tumour Lysis Syndrome (TLS)

Section 4.8: Addition of “Hypothalamic pituitary adrenal axis suppression” as an Endocrine disorder replacing Hypopituitarism.

Updated on 26 September 2023

File name

RegHCPLeafletSC121PILSC182IEclean.pdf

Reasons for updating

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

Updated on 14 February 2023

File name

Reg SPC SC 17_1 IE_clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 22 October 2021

File name

Reg SPC SC 17_1 IE_clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Updated on 22 October 2021

File name

Reg HCP Leaflet SC 12_1 & PIL SC 17_1 IE_clean.docx .pdf

Reasons for updating

  • Change to information for healthcare professionals
  • Change to date of revision

Updated on 20 April 2021

File name

DEC202125870_Reg SPC SC 16_2 IE clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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:

4.4 Special warnings and precautions for use

Added

Excipient information This medicinal product contains 10.1 mg of sodium, equivalent to 0.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Updated
4.8 Reporting of suspected adverse reactions

Updated on 20 April 2021

File name

DEC202125870_Reg HCP Leaflet SC 11_2 & PIL SC 16_2 IE clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 17 November 2020

File name

DEC202076769_Reg SPC SC 15_2 IE clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications

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

Updated on 17 November 2020

File name

DEC202076769_Reg HCP Leaflet SC 11_2 & PIL SC 15_2 IE clean.pdf

Reasons for updating

  • 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 6 - date of revision
  • Change to information for healthcare professionals

Updated on 11 August 2020

File name

DEC202052681_Reg SPC SC 13_1 IE 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 not be renewed (A)

Updated on 11 August 2020

File name

DEC202052681_Reg HCP Leaflet SC 10_0 & PIL SC 13_1 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 28 November 2018

File name

Reg SPC SC 12_1 IE.pdf

Reasons for updating

  • Improved presentation of SPC

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

Free text change information supplied by the pharmaceutical company

Improved presentation of SPC uploaded

Updated on 28 August 2018

File name

Reg_SPC_SC_12_1_IE_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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:
Section 4.4 and 4.8 revised to add warnings concerning “blurred vision”

Updated on 18 May 2018

File name

Reg_SPC_SC_12_1_IE_clean.docx

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:
Section 4.4 and 4.8 revised to add warnings concerning “blurred vision”

Updated on 18 May 2018

File name

Reg HCP Leaflet SC 10_0 & PIL SC 12_1 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 04 April 2018

Reasons for updating

  • New SPC for new product

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

Updated on 04 April 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:
Section 4.5 of the SPC updated regarding oestrogen-induced potentiation of the effects of hydrocortisone.

Updated on 29 March 2018

File name

PIL_10821_836.pdf

Reasons for updating

  • New PIL for new product

Updated on 29 March 2018

Reasons for updating

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

Updated on 04 September 2017

Reasons for updating

  • 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 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 26 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 26 August 2017

Reasons for updating

  • 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 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

SCP sections 4.3, 4.4, 4.5, 4.6, 4.8, 4.9 and 5.3 revised in accordance with the CDS.

Updated on 28 July 2015

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.4 Special warnings and precautions for use: 

Updated information about corticosteroid use with systemic corticosteroids

Addition of thrombosis warning with corticosteroids

 

Section 4.8 Undesirable effects

Updated with Thrombosis and Pulmonary embolism

Updated on 18 December 2014

Reasons for updating

  • 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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

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 4.4 – Special warnings and precautions for use – Warning against using high doses for traumatic brain injury

Section 4.6 - Fertility, pregnancy and lactation – Impaired fertility in animal studies

Section 4.8 – Undesirable effects – Update to HPRA address

Section 5.1 - Pharmacodynamic properties – Add Pharmacotherapeutic group

Section 5.3 – Preclinical safety data – New preclinical data

Updated on 16 December 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 20 May 2014

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 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 4.4 - Addition of two warnings Central Serous Chorioretinopathy & Epidural Lipomatosis.
Section 4.8  - Revision of the tabulation of the side effects & addition of frequencies (all unknown), plus addition of the side effects - Central Serous Chorioretinopathy & Epidural Lipomatosis                Minor changes made to sections: 2, 3, 4.2, 4.3, and  6.5

Updated on 16 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 17 June 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines

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

Free text change information supplied by the pharmaceutical company

Update to sections 2, 4.2, 4.4 and 4.7

Updated on 10 June 2013

Reasons for updating

  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration
  • Changes to therapeutic indications
  • Improved electronic presentation

Updated on 03 January 2012

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

 MAH changed, PA number changed.

Updated on 23 December 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 17 October 2011

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • 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

SmPC changes to sections 7 & 10

Updated on 14 October 2011

Reasons for updating

  • Change to marketing authorisation holder

Updated on 15 June 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 11 April 2011

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 - Warning added concerning potentially severe psychiatric adverse reactions may occur with systemic steroids, normally within a few days or weeks of starting treatment.
Section 4.8 - Inclusion of psychiatric reactions including irritability, depression, psychological dependence and suicidal thoughts.

Updated on 08 April 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to how the medicine works

Updated on 06 September 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 9 - Date of renewal of authorisation

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

Free text change information supplied by the pharmaceutical company

SmPC
Section 1:
Trade name updated to reflect that the solvent is not supplied in the 10 pack vial.

Section 2:
Adding the quantity of sodium present in vial

Section 5.1
Addition of ATC Code

Section 6.1
Information added regarding sodium hydroxide

Section 6.2
Addition of standard statement

Section 9
Latest renewal approval date added

Updated on 06 September 2010

Reasons for updating

  • Change to product name

Updated on 26 April 2006

Reasons for updating

  • New PIL for medicines.ie

Updated on 20 April 2006

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • 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 7 - Marketing authorisation holder
  • 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 not be renewed (A)

Updated on 15 August 2005

Reasons for updating

  • New SPC for medicines.ie

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