Reagila 4.5 mg hard capsules

*
Pharmacy Only: Prescription
  • Company:

    Recordati Ireland Limited
  • 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 19 April 2024

File name

ie-reagila-spc-Feb2022.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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

Updated on 17 February 2023

File name

ie-spc-reagila-february2022.pdf

Reasons for updating

  • Document format updated

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

Updated on 20 April 2022

File name

Reagila SmPC.pdf

Reasons for updating

  • 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 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Removal of Black Inverted Triangle

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

Updated on 20 April 2022

File name

pil_REAGILA_caps_UK-IE.pdf

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Removal of black triangle for intensive monitoring, update to contraceptive advice, minor update to side effects

Updated on 07 January 2022

File name

reaglia - IE SmPC.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

additional pack size for 4.5 mg and 6 mg capsules

Updated on 07 January 2022

File name

pil_REAGILA_caps_UK-IE_K27681-15_29431320-cropped.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

add pack size for 4.5 mg and 6 mg capsules

Updated on 21 October 2020

File name

reagila-PIL.pdf

Reasons for updating

  • Removal/change of distributor

Updated on 27 June 2019

File name

reagila-PIL.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 June 2019

File name

reagila-SmPC.pdf

Reasons for updating

  • New SPC for new product

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