Solu-Medrone 500 mg

  • Name:

    Solu-Medrone 500 mg

  • Company:
    info
  • Active Ingredients:

    Methylprednisolone sodium succinate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/06/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 23/6/2020

Click on this link to Download PDF directly

Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 231 items.Total: Infinity pages

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 26 June 2020 PIL

Reasons for updating

  • Change to information for healthcare professionals

Updated on 23 June 2020 SmPC

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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.2 Indication
Dosing for the indication Multiple sclerosis unresponsive to standard therapy (or during exacerbation episodes) updated to
"Administer for 3 or 5 days a dose of either 500 mg/day or 1 g/day as IV pulse dosing over at least 30 minutes."

Updated on 23 June 2020 PIL

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 12 December 2019 PIL

Reasons for updating

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

Updated on 13 September 2019 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Free text change information supplied by the pharmaceutical company

The PIL and HCP Section has been updated to reflect the SPC changes. See PIL tick list for sections updated.

Updated on 13 September 2019 SmPC

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • 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 as follows:

Section 6.4 – revised to state This medicinal product does not require any special storage conditions.

Section 10 – date of revision of text updated

Updated on 28 November 2018 SmPC

Reasons for updating

  • Improved presentation of SmPC

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 SmPC

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:

Sections 4.4 and 4.8 updated to include “blurred vision” warnings

Updated on 30 May 2018 SmPC

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:

Sections 4.4 and 4.8 updated to include “blurred vision” warnings

Updated on 21 May 2018 PIL

Reasons for updating

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

Updated on 2 May 2018 SmPC

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

The SPC has been updated as follows:

In section 4.4 detail of scleroderma has been added to the section on Renal and urinary disorders

Updated on 26 April 2018 PIL

Reasons for updating

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

Updated on 13 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 March 2017 SmPC

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

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

Free text change information supplied by the pharmaceutical company

Updates to sections 4.4 and 4.5 of the Summary of Product Characteristics (SmPC)

arising from PRAC recommendation 10 November 2016 EMA/PRAC/700146/2016. The updates concern increased risk of systemic side effects when corticosteroids are co-administered with CYP3A inhibitors, including cobicistat containing products.

Updated on 28 March 2017 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 28 March 2017 PIL

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

Free text change information supplied by the pharmaceutical company

Updates to sections 4.4 and 4.5 of the Summary of Product Characteristics (SmPC)

arising from PRAC recommendation 10 November 2016 EMA/PRAC/700146/2016. The updates concern increased risk of systemic side effects when corticosteroids are co-administered with CYP3A inhibitors, including cobicistat containing products.

Updated on 19 January 2017 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: 4.3 Contradictions
•           for use by the epidural route of administration.>

Updated on 19 January 2017 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

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: 4.3 Contradictions
•           for use by the epidural route of administration.>

Updated on 5 December 2016 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: 4.3 Contradictions
•           for use by the epidural route of administration.>

Updated on 5 December 2016 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications

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: 4.3 Contradictions
•           for use by the epidural route of administration.>

Updated on 20 September 2016 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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)

Free text change information supplied by the pharmaceutical company

Updates to sections 4.4, 4.6, 4.8, 5.2 & 5.3 following CDS update.

Updates to section 4.2 to correct Act-o-Vial usage instructions.

Updated on 20 September 2016 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

Updates to sections 4.4, 4.6, 4.8, 5.2 & 5.3 following CDS update.

Updates to section 4.2 to correct Act-o-Vial usage instructions.

Updated on 11 February 2016 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Sections 4.4 and 4.8 have been updated in line with recommended PRAC wording.

Updated on 11 February 2016 SmPC

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:

Sections 4.4 and 4.8 have been updated in line with recommended PRAC wording.

Updated on 20 August 2015 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.8 Undesirable effects

Updated with Thrombosis and Pulmonary embolism

Updated on 20 August 2015 SmPC

Reasons for updating

  • 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 4.8 Undesirable effects

Updated with Thrombosis and Pulmonary embolism

Updated on 2 June 2015 SmPC

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
  • 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 4.2 Posology and method of administration

Updated with paediatric population and benzyl alcohol warning

Section 4.3 Contraindications

Removal of epidural contraindication

Section 4.4 Special warnings and precautions for use: 

Removal of warnings concerning corticosteroids and addition of warning for Pheochromocytoma crisis

Section 4.5 Interaction with other medicinal products and other forms of interaction

Interactions updated

Section 4.6 Fertility, pregnancy and lactation

Benzyl alcohol update

Section 4.7 Effects on ability to drive and use machines

Updated warning

Section 4.8 Undesirable effects:

Table updated

Section 4.9 Overdose:

Updated information

Section 5.1

Update to ATC code and therapeutic group

Section 5.2

Update to pharmacodynamics data

Section 5.3

Update to preclinical data

 

Updated on 2 June 2015 PIL

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
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.2 Posology and method of administration

Updated with paediatric population and benzyl alcohol warning

Section 4.3 Contraindications

Removal of epidural contraindication

Section 4.4 Special warnings and precautions for use: 

Removal of warnings concerning corticosteroids and addition of warning for Pheochromocytoma crisis

Section 4.5 Interaction with other medicinal products and other forms of interaction

Interactions updated

Section 4.6 Fertility, pregnancy and lactation

Benzyl alcohol update

Section 4.7 Effects on ability to drive and use machines

Updated warning

Section 4.8 Undesirable effects:

Table updated

Section 4.9 Overdose:

Updated information

Section 5.1

Update to ATC code and therapeutic group

Section 5.2

Update to pharmacodynamics data

Section 5.3

Update to preclinical data

 

Updated on 26 May 2015 PIL

Reasons for updating

  • Improved electronic presentation

Free text change information supplied by the pharmaceutical company

change version code

Updated on 26 May 2015 SmPC

Reasons for updating

  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

change version code

Updated on 21 May 2015 PIL

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
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows:

Section 4.2 Posology and method of administration

Updated with paediatric population and benzyl alcohol warning

Section 4.3 Contraindications

Removal of epidural contraindication

Section 4.4 Special warnings and precautions for use: 

Removal of warnings concerning corticosteroids and addition of warning for Pheochromocytoma crisis

Section 4.5 Interaction with other medicinal products and other forms of interaction

Interactions updated

Section 4.6 Fertility, pregnancy and lactation

Benzyl alcohol update

Section 4.7 Effects on ability to drive and use machines

Updated warning

Section 4.8 Undesirable effects:

Table updated

Section 4.9 Overdose:

 

Section 5.1

Update to ATC code and therapeutic group

Section 5.2

Update to pharmacodynamics data

Section 5.3

Update to preclinical data

Updated on 21 May 2015 SmPC

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
  • 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 4.2 Posology and method of administration

Updated with paediatric population and benzyl alcohol warning

Section 4.3 Contraindications

Removal of epidural contraindication

Section 4.4 Special warnings and precautions for use: 

Removal of warnings concerning corticosteroids and addition of warning for Pheochromocytoma crisis

Section 4.5 Interaction with other medicinal products and other forms of interaction

Interactions updated

Section 4.6 Fertility, pregnancy and lactation

Benzyl alcohol update

Section 4.7 Effects on ability to drive and use machines

Updated warning

Section 4.8 Undesirable effects:

Table updated

Section 4.9 Overdose:

 

Section 5.1

Update to ATC code and therapeutic group

Section 5.2

Update to pharmacodynamics data

Section 5.3

Update to preclinical data

Updated on 8 January 2015 PIL

Reasons for updating

  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Please note that the only differences are the version numbers and revision dates.

Updated on 8 January 2015 SmPC

Reasons for updating

  • 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 note that the only differences are the version numbers and revision dates.

Updated on 6 November 2014 SmPC

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

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

Free text change information supplied by the pharmaceutical company

Addition of statement to section 4.4 regarding discouraging the use of high doses of corticosteroids to treat traumatic brain injury and correction in section 4.2 from Pneumocystis carinii to Pneumocystis jiroveci

Updated on 6 November 2014 PIL

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Free text change information supplied by the pharmaceutical company

Addition of statement to section 4.4 regarding discouraging the use of high doses of corticosteroids to treat traumatic brain injury and correction in section 4.2 from Pneumocystis carinii to Pneumocystis jiroveci