Procysbi 25mg / 75mg gastro-resistant hard capsules
- Name:
Procysbi 25mg / 75mg gastro-resistant hard capsules
- Company:
Chiesi Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 16/12/20

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Chiesi Limited

Company Products
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 16 December 2020 PIL
Reasons for updating
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Following the below approval to change the local representative in IT, we have now been advised to update the PIL revision date in line with Italy (10/2020) – please note all other content remains the same.
The new PIL code is CP0062-6 superseding CP0062-5.
Updated on 17 September 2019 SPC
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 SPC
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 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
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Educational Materials for Medicines
Educational Materials for Medicines