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Salazopyrin EN Tablets

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Sulfasalazine

    *Additional information is available within the SPC or upon request to the company

Updated on 21 June 2023

File name

Reg SPC SZ 162 En Tabs IE clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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 be renewed (B)

Updated on 21 June 2023

File name

Reg PIL Z 205 En Tabs IE clean.pdf

Reasons for updating

  • 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 - excipient warnings
  • 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 looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 14 February 2023

File name

Reg SPC SZ 15_3 En-Tabs IE - clean.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 15 October 2021

File name

Reg SPC SZ 15_3 En-Tabs IE - clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 6.1 - List of excipients
  • Change to section 11 - Dosimetry

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 15 October 2021

File name

Reg PIL SZ 19_3 En-Tabs 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

Updated on 10 September 2019

File name

DEC201948330_Reg SPC SZ 14_0 En-Tabs IE - clean.pdf

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 be renewed (B)

Updated on 10 September 2019

File name

DEC201948330_Reg PIL SZ 18_0 En-Tabs IE - clean.pdf

Reasons for updating

  • 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 6 - date of revision

Updated on 29 January 2019

File name

DEC201904106_Reg PIL SZ 17_0 En-Tabs IE clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 02 August 2018

File name

Reg PIL SZ 16_0 En-Tabs IE - clean.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 SZ 13_0 En-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 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 09 March 2017

File name

PIL_12079_31.pdf

Reasons for updating

  • New PIL for new product

Updated on 09 March 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains

Updated on 27 October 2015

Reasons for updating

  • Change to packaging
  • Change to side-effects
  • Change to date of revision

Updated on 02 July 2015

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 02 July 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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 4.8 Reporting of side effects.  Replaced IMB contact details with new HPRA contact details.

Updated on 25 March 2014

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 4.4 - 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

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 2:         Typographical changes

Section 4.1:      Indications changed to indications

Section 4.2:      Posology and method of Administration changed to Posology and method of administration, Elderly to elderly, Sub-heading “Paediatric populations” added and typographical changes to address inconsistencies in the way that “sections” are cross referenced

Section 4.4       additions of exfoliative dermatitis to skin conditions, text relating to DRESS

Section 4.5       Typographical changes including to address inconsistencies in the way that “sections” are cross referenced, update on the interaction of sulfonamides with folic-acid antagonists or hypoglycaemics, update on interference with measurements with liquid chromatography

Section 4.6       Typographical changes including to address inconsistencies in the way that “sections” are cross referenced, update on reports of babies with neural tube defects born to mothers

Section 4.7       Typographical changes including to address inconsistencies in the way that “sections” are cross referenced

Section 4.8       Updated in line with QRD; minor typographical changes, addition of anaphylaxis, angioedema, pseudomononucleosis, myocarditis, oropharyngeal pain,jaundice,cholestasis, nephrolithiasis

 

Updated on 18 March 2014

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 09 December 2013

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 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

section 4.5, section 4.5, section  4.8 and section  10

Updated on 03 December 2013

Reasons for updating

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

Updated on 25 February 2013

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 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

sections 4.4 and 4.6  

Updated on 20 February 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to date of revision

Updated on 30 October 2012

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 4.8 to implement PhVWP wording regarding the Stevens-Johnson-Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

Updated on 23 October 2012

Reasons for updating

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

Updated on 18 April 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

SPC change of MA holder from Pharmacia to Pfizer Limited and PA number.

Updated on 17 April 2012

Reasons for updating

  • Change of licence holder

Updated on 09 February 2010

Reasons for updating

  • Change due to user-testing of patient information

Updated on 16 September 2009

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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Updated Section 4.3 of the SPC to include:
hypersensitivity warnings regarding metabolites or excipients of product

Updated Section 4.4 of the SPC to include:
warnings on use in children with systemic onset juvenile rheumatoid arthritis and caution in use with patients with severe allergy or bronchial asthma

Updated Section 4.5 of the SPC to include:
interactions with azathioprine and methotrexate

UpdatedSection 4.6 of the SPC to include:
information regarding sulfapyridine being found in low levels in breast milk

Updated Section 4.7 of the SPC to:
state that the effect of sulfasalazine on the ability to drive and use machinery has not been systematically evaluated.

Updated Section 4.8 of the SPC to include:
DRESS, hepatic failure, hepatitis fulminant, diarrhoea, vomiting, and interstitial lung disease and add frequencies to the existing AE’s where known

Updated Section 4.9 of the SPC to include:
common symptoms of overdose and treatment is symptomatic and should be supportive

Updated on 15 September 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions

Updated on 15 December 2008

Reasons for updating

  • 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 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.6 has been updated to change Sulphapyridine to Sulfapyridine

Section 4.8 has been updated to change Sulphapyridine to Sulfapyridine

Section 5.1 has been updated to change Sulphapyridine to Sulfapyridine

Section 5.2 has been updated to change Sulphapyridine to Sulfapyridine

Updated on 08 December 2008

Reasons for updating

  • Change of trade or active ingredient name
  • Change of inactive ingredient
  • Change to storage instructions

Updated on 04 December 2008

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 6.1 - List of excipients
  • Change to section 9 - Date of renewal of authorisation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1 has been updated to include the full Ph. Eur. pharmaceutical form (gastro-resistant tablets)

Section 6.1 has been updated to include propylene glycol

Section 9 has been updated to include the new renewal date

Updated on 29 August 2007

Reasons for updating

  • Change to marketing authorisation holder address

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7 - Change to MAH address

Updated on 27 June 2007

Reasons for updating

  • Change of manufacturer

Updated on 14 June 2007

Reasons for updating

  • New PIL for medicines.ie

Updated on 24 May 2005

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 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 July 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)