OxyNorm 5mg capsules
*Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp LaboratoriesStatus:
UpdatedLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 21 March 2025
File name
SmPC-IE-OxyNorm 5mg capsules-clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
4.4 Special warnings and precautions for use
Hepatobiliary disorders
Oxycodone may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis. Therefore, oxycodone has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
10. Date of (partial) revision of the text
Updated on 21 March 2025
File name
PIL-IE-OxyNorm 5, 10, 20 mg capsules-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
2. What you need to know before you take OxyNorm
Tolerance, dependence and addiction
-This medicine contains oxycodone, which is an opioid. It can cause dependence and/or addiction.
3.How to take OxyNorm
If you take more OxyNorm than you should or if someone accidentally swallows your capsules
Call your doctor or hospital straight away.
An overdose may result in:
· a reduction in size of pupils in the eye
· breathing more slowly or weakly than expected (respiratory depression)
· drowsiness or loss of consciousness
· low muscle tone (hypotonia)
· reduced pulse rate
· a fall in blood pressure
· difficulty in breathing due to fluid on the lungs (pulmonary oedema).
· a brain disorder (known as toxic leukoencephaltopathy)
This leaflet was last revised in February 2025.
® OxyNorm, MUNDIPHARMA and the ‘mundipharma’ logo are Registered Trade Marks.
© 2010-2025 Napp Pharmaceuticals Limited
Updated on 23 May 2024
File name
Proposed_IE_SmPC_OxyNorm_Capsules_5mg_PSUSA-00002254-202304_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 23 May 2024
File name
Proposed_IE_PIL_OxyNorm_Capsules_5-10-20mg_PSUSA-00002254-202304_clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
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
Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
Address:
United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, IrelandMedical Information E-mail:
medicalinformation@mundipharma.ieTelephone:
Medical Information Direct Line:
+44 174 882 8867