Cerdelga 84 mg capsules, hard
*Company:
Sanofi GenzymeStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
This medicinal product is subject to additional monitoring.
*Additional information is available within the SPC or upon request to the company
File name
Cerdelga IE - Guide for Prescriber.pdf
Reasons for updating
- Replace File
File name
Cerdelga IE - Patient Card.pdf
Reasons for updating
- Replace File
Updated on 17 December 2024
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Cerdelga.pdf
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 4.1 - Therapeutic indications
- 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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 - Pharmaceutical particulars
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 December 2024
File name
1.3.1.3 Package Leaflet (PIL text) Cerdelga.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- 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 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 3 - duration of treatment
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
File name
Cerdelga IE aRMM - Guide for Prescribers.pdf
Reasons for updating
- Replace File
File name
Cerdelga IE aRMM - Patient Card.pdf
Reasons for updating
- Replace File
Updated on 07 December 2023
File name
1.3.2.1 Mock-up - Package Leaflet (PIL) Cerdelga (1).pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 02 August 2023
File name
1.3.1 SPC IE-UKNI (20).pdf
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)
Updated on 02 August 2023
File name
1.3.1 PIL text IE-UKNI (3).pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 17 July 2023
File name
1.3.2 Mock-up PIL IE-XI (4).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 06 July 2023
File name
1.3.1 SPC IE-UKNI (19).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 06 July 2023
File name
1.3.1 PIL text IE-UKNI (2).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 29 March 2023
File name
1.3.2 Mock-up PIL IE-XI (2).pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 14 March 2023
File name
Aldurazyme.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 14 March 2023
File name
1.3.2 Mock-up PIL IE-XI.pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 03 December 2021
File name
1.3.1 PIL text IE-UKNI (1).pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 04 December 2020
File name
1.3.1 PIL (10).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 09 November 2020
File name
1.3.1 PIL (7).pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 06 July 2020
File name
IE.pdf
Reasons for updating
- XPIL Removed
File name
Cerdelga Risk Minimisation Patient Card Ireland_IRE_ GZUK.CERD.17.03.0132c(1).pdf
Reasons for updating
- Replace File
Updated on 18 February 2020
File name
IE.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 18 February 2020
File name
1.3.2 Mock-up PIL UK.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 24 December 2019
File name
Cerdelga SPC.pdf
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 3 - Pharmaceutical form
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 24 December 2019
File name
Cerdelga PIL.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
File name
Patient Alert care.pdf
Reasons for updating
- Add New Doc
Updated on 16 September 2019
File name
PIL (IE).pdf
Reasons for updating
- New PIL for medicines.ie
File name
IE Prescriber Guide.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
To avoid any misinterpretation and to ensure the terms contained within the prescriber guide are aligned with HSE Code of Practice requirements, Sanofi Genzyme have amended the prescriber guide to remove reference to “QD” throughout and replace this with the wording “Once daily”.
Updated on 02 May 2019
File name
SPC Cerdelga 84mg capsules SA1434.pdf
Reasons for updating
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
5.2 Pharmacokinetic properties
Absorption
Median time to reach maximum plasma concentrations occurs between 1.5 to 36 hours after dosing, with low oral bioavailability (<5%) due to significant first-pass metabolism. Eliglustat is a substrate of the efflux transporter P-gp. Food does not have a clinically relevant effect on eliglustat pharmacokinetics. Following repeated dosing of eliglustat 84 mg twice daily in non-PMs and once daily in PMs, steady state was reached by 4 days, with an accumulation ratio of 3-fold or less. Oral dosing of 84 mg eliglustat once daily has not been studied in CYP2D6 poor metabolisers (PMs).
Characteristics in specific groups
CYP2D 6 phenotype
Updated on 07 January 2019
File name
PIL Cerdelga 84mg capsules, hard.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - marketing authorisation holder
Updated on 07 January 2019
File name
SPC Cerdelga 84mg capsules, hard.pdf
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
4.9 Overdose
The highest eliglustat plasma concentration observed to date occurred in a Phase 1 single-dose dose escalation study in healthy subjects, in a subject taking a dose equivalent to approximately 21 times the recommended dose for GD1 patients. At the time of the highest plasma concentration (59-fold higher than normal therapeutic conditions), the subject experienced dizziness marked by disequilibrium, hypotension, bradycardia, nausea, and vomiting.
In the event of acute overdose, the patient should be carefully observed and given symptomatic treatment and supportive care.
7. MARKETING AUTHORISATION HOLDER
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands
Updated on 21 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 14 December 2017
File name
PIL_17158_657.pdf
Reasons for updating
- New PIL for new product
Updated on 14 December 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 16 May 2017
Reasons for updating
- New PIL for medicines.ie
- Retired from medicines.ie
Sanofi Genzyme
Address:
CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELANDMedical Information E-mail:
iemedinfo@sanofi.comTelephone:
+353 1 4035600