OxyNorm 5mg capsules

*
Pharmacy Only: Prescription

Updated on 14 December 2023

File name

OxyNorm 5 mg Capsules SPC IE- clean.pdf

Reasons for updating

  • 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 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updated to implement the outcome of an Article 45 procedure FR/W/0010/pdWS/01.

Amendments made to include the text concerning the addition of the paediatric indication in the paediatric subset 12 to 18 years of age.

Updated on 14 December 2023

File name

OxyNorm Capsules PIL - Ireland_clean.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

Updated to implement the outcome of an Article 45 procedure FR/W/0010/pdWS/01.

Amendments made to include the text concerning the addition of the paediatric indication in the paediatric subset 12 to 18 years of age.

Updated on 08 August 2023

File name

OxyNorm 5 mg Capsules SPC - IE-clean.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
  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

section 4

Updated on 08 August 2023

File name

OxyNorm Capsules PIL -IE-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose

Updated on 30 March 2023

File name

OxyNorm 5 mg Capsules SPC-IE-clean.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to IE MAH address

Updated on 30 March 2023

File name

OxyNorm Capsules PIL-IE-clean.pdf

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Change to IE MAH address