OxyNorm Dispersa 20 mg orodispersible tablets
*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 24 March 2025
File name
IE-PIL-OxyNorm Dispersa 5, 10, 20 mg-PSUSA 202404-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- 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 Dispersa tablets
Warnings and precautions
Tolerance, dependence and addiction
This medicine contains oxycodone, which is an opioid. It can cause dependence and/or addiction.
Updated on 24 March 2025
File name
IE-SmPC-OxyNorm Dispersa 20 mg-PSUSA 202404-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.
Updated on 06 March 2024
File name
OxyNorm Dispersa 20 mg- SPC-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 06 March 2024
File name
OxyNorm Dispersa 5-10-20 mg-PIL-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 14 December 2023
File name
OxyNorm Dispersa 20 mg- SPC-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 Dispersa 5-10-20 mg-PIL-clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - use in children/adolescents
- Change to section 6 - date of revision
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 09 May 2023
File name
OxyNorm Dispersa 20 mg- SPC-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)
Updated on 09 May 2023
File name
OxyNorm Dispersa 5-10-20 mg-PIL-clean.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
Updated on 30 March 2023
File name
oxynorm dispersa-20mg-spc-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
IE MAH Address Change
Updated on 30 March 2023
File name
oxynorm dispersa-5-10-20mg-pil-clean.pdf
Reasons for updating
- New PIL for new product
Free text change information supplied by the pharmaceutical company
IE MAH Address Change
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