Cerdelga 84 mg capsules, hard
- Name:
Cerdelga 84 mg capsules, hard
- Company:
Sanofi Genzyme
- 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: 04/12/20

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Sanofi Genzyme
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 4 December 2020 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 9 November 2020 PIL
Reasons for updating
- Change to section 6 - manufacturer
Updated on 6 July 2020 PIL
Reasons for updating
- XPIL Removed
Updated on 27 March 2020 Ed-Ptnt
Reasons for updating
- Replace document
Updated on 18 February 2020 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 18 February 2020 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 24 December 2019 SPC
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 PIL
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
Updated on 11 October 2019 Ed-Ptnt
Reasons for updating
- Add New Doc
Updated on 16 September 2019 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 22 August 2019 Ed-HCP
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 2 May 2019 SPC
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 7 January 2019 PIL
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 7 January 2019 SPC
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 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 14 December 2017 PIL
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 PIL
Reasons for updating
- New PIL for medicines.ie
- Retired from medicines.ie
Prescriber GuideRisk Minimisation Materials
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Educational Materials for Medicines
Educational Materials for Medicines
Patient Alert cardRisk Minimisation Materials
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Educational Materials for Medicines
Educational Materials for Medicines