Cuprior 150mg Film-coated tablets
*Company:
OrphalanStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 22 December 2023
File name
IRE PIL.pdf
Reasons for updating
- 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 - excipient warnings
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- 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 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
Updated on 22 December 2023
File name
IRE SmPC.pdf
Reasons for updating
- 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 - how to report a side effect
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- 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 4.2
Wording for posology has been amended to add clarity:
Adult
The recommended dose is between 450 mg and 975 mg (3 to 6 and a half film-coated tablets) per day in 2 to 4 divided doses.
Paediatric population
The starting dose in paediatrics is lower than for adults and depends on age and may be calculated using body weight. The dose should subsequently be adapted according to the child’s clinical response (see section 4.4)
Children and adolescents (≥ 5 years to 18 years)
The dose is usually between 225 mg and 600 mg per day (1 and a half to 4 film-coated tablets) in 2 to 4 divided doses.
Section 4.4.
Wording on sodium added.
Section 4.8
HPRA reporting details expanded upon. MHRA reporting details removed.
Section 6.1
Titanium dioxyde changed to Titanium dioxide
Section 6.5
OPA/Alu/PVC-Alu blisters changed to oPA/Alu/PVC//Alu blisters
Section 8
MA number updated
Section 9 + 10
Dates updated in line with renewal.
Updated on 30 October 2020
File name
PIL Cuprior rev 07_2020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 30 October 2020
File name
SMPC Cuprior rev 07_2020.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 11 May 2020
File name
2020_01_en_PIL.pdf
Reasons for updating
- New PIL for new product
Updated on 11 May 2020
File name
2020_01_en_SmPC.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)