Procysbi 25mg / 75mg gastro-resistant hard capsules

  • Name:

    Procysbi 25mg / 75mg gastro-resistant hard capsules

  • Company:
    info
  • Active Ingredients:

    Cysteamine (as mercaptamine bitartrate)

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/07/19

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Summary of Product Characteristics last updated on medicines.ie: 17/9/2019

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Chiesi Limited

Chiesi Limited

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Medicine Name CUROSURF 240mg Active Ingredients phospholipid fraction from porcine lung (poractant alfa)
Medicine Name Envarsus 0.75mg; 1mg; 4mg prolonged-release tablet Active Ingredients Tacrolimus Monohydrate
Medicine Name Peyona (caffeine citrate) 20 mg/ml solution for infusion and oral solution Active Ingredients Caffeine citrate
Medicine Name Procysbi 25mg / 75mg gastro-resistant hard capsules Active Ingredients Cysteamine (as mercaptamine bitartrate)
Medicine Name Quinsair 240 mg nebuliser solution Active Ingredients Levofloxacin hemihydrate
Medicine Name Zileze 3.75mg Film Coated Tablets Active Ingredients Zopiclone
Medicine Name Zileze 7.5mg Film Coated Tablets Active Ingredients Zopiclone
1 - 0 of 9 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 17 September 2019 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Reasons for adding or updating:

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SmPC:01-09-2019

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

 

Shelf life now changed from 18 months to 24 months:

 

6.3 Shelf life

 

24 months

 In-use shelf life: 30 days

 

Date of revision of text changed to  

09/2018

Updated on 4 September 2019 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Admin error on last entry identified

The national reporting adverse event reporting information was missing from bottom of section 4.8.

This was changed from

Reporting of suspected adverse reactions

 Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

  

This was changed to

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

United Kingdom: Yellow Card Scheme at www.mhra.gov.uk/yellowcard  

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie

 

No other changes have been made

Updated on 25 July 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 25 July 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 25 July 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 25 July 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 25 July 2019 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 1 July 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 July 2019 SmPC

Reasons for updating

  • New SmPC for new product

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

  • PROCYSBI - AE Follow Up Form for Ehlers-Danlos-like SyndromeRisk Minimisation Materials

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  • PROCYSBI - Safety Checklist for Prescribing PhysiciansRisk Minimisation Materials

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  • PROCYSBI - AE Follow Up Form for EncephalopathyRisk Minimisation Materials

    files-icon(Click to Download)
  • PROCYSBI - AE Follow Up Form for Fibrosing ColonopathyRisk Minimisation Materials

    files-icon(Click to Download)
  • PROCYSBI - AE Follow Up Form for PregnancyRisk Minimisation Materials

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