Cuprior 150mg Film-coated tablets

*
Pharmacy Only: Prescription
  • Company:

    Orphalan
  • Status:

    No Recent Update
  • Legal 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 30 April 2024

File name

Ireland ema 2024 v1.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may be renewed (B)

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)