OxyNorm concentrate 10mg/ml oral solution
*Company:
Mundipharma Pharmaceuticals Limited - Formerly Napp LaboratoriesStatus:
No Recent UpdateLegal 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 14 December 2023
File name
OxyNorm Concentrate 10 mgml 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 Concentrate 10 mgml PIL - Ireland_v1.0-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 08 August 2023
File name
OxyNorm Concentrate 10 mgml 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)
Updated on 08 August 2023
File name
OxyNorm Concentrate 10 mgml 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)
Updated on 08 August 2023
File name
OxyNorm Concentrate 10 mgml PIL - Ireland_v1.0-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 Concentrate 10 mgml SPC-IE-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 30 March 2023
File name
OxyNorm Concentrate 10 mgml PIL-IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 16 March 2022
File name
spc conc.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 2 - Editorial updates to the expression of the composition and sodium warning.
Section 4.3 - Contraindications reorganised into bullet point format and aligned with company core data sheet.
Section 4.4 - Warnings reorganised into bullet point format and aligned with company core data sheet. Addition of warning regarding sleep apnoea. Addition of warning regarding concommitant use of MAOIs. Addition of warnings regarding sodium content. Editorial updates.
Section 4.6 - Addition of statement regarding human data on fertility.
Section 4.8 - Addition of sleep apnoea as a possible side effect.
Updated on 24 June 2021
File name
pil conc.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
Free text change information supplied by the pharmaceutical company
Section 2 - Warnings and Precautions - Addition of paragraph regarding use in chronic non-malignant pain.
Section 2 - Interactions - Addition of gabapentinoids as potential interacting medicines.
Updated on 24 June 2021
File name
spc conc.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2 - Clarification that the dose should be adjusted based on the individual patient requirements, and that the lowest effective dose should be used. Addition of paragraph on transfer between oral and parenteral oxycodone.
Section 4.4 - Addition of paragraph regarding use in chronic non-malignant pain.
Section 4.5 - Addition of gabapentinoids as potential interacting medicines, and administrative updates.
Section 5.2 - Reorganisation of section into ADME format and addition of paragraphs on patients with hepatic and renal dysfunction.
Section 5.3 - Addition of preclinical data from company core datasheet.
Updated on 03 April 2019
File name
Approved_package_leaflet_clean_Oral_Solution_OxyNorm_Concentrate_10_mg_ml_serotonergic_medicines_ie.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 03 April 2019
File name
Approved_SPC_Clean_Oral_Solution_English_OxyNorm_Concentrate_10_mg_ml_serotonergic_medicines_ie.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to section 4.5 of the SPC to include concomitant administration of oxycodone with serotonin agents.
Updated on 05 November 2018
File name
ie-pl-cleanoxynormconcentrate10mgmlosoen_medicines_ie.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
Updated on 05 November 2018
File name
ie-spc-cleanoxynormconcentrate10mgmlosoen_medicines_ie.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
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Update to sections 4.4 and 4.5 to include information regarding concomitant use of opioids and sedative medicines such as benzodiazepines:
Section 4.4:
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs:
Concomitant use of opioids, including oxycodone hydrochloride and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma, and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe oxycodone hydrochloride concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).
Section 4.5:
The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4). Drugs which affect the CNS include, but are not limited to: alcohol, other opioids, non-benzodiazepine sedatives, hypnotics, antidepressants, anaesthetics, muscle relaxants, neuroleptic drugs, antihypertensives and SSRIs. Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.
Updated on 07 February 2018
File name
PIL_8298_405.pdf
Reasons for updating
- New PIL for new product
Updated on 07 February 2018
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 06 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 06 February 2018
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 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 on 31 October 2016
Reasons for updating
- Change to section 6 - date of revision
- Change to section 6 - manufacturer
Updated on 14 August 2015
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 4.5 - 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
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2
Added the following heading:
Conversion from oral morphine
Text in red has been added:
Adults under 20 years and paediatric population (children has been deleted)
The headings Method of administration: Oral use has been moved.
Section 4.4 text in red and with strike through has been deleted
Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur, particularly in high doses. An oxycodone dose reduction or change to an alternative opioid may be required.
Section 4.5
There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect the CNS such as phenothiazines, tricyclic antidepressants, anaesthetics, hypnotics, sedatives, muscle relaxants, other opioids, neuroleptic drugs, antihypertensives and SSRIs.
The following text has been added
Concomitant administration of oxycodone with anticholinergics or medicines with anticholinergic activity (e.g. tricyclic anti-depressants, antihistamines, antipsychotics, muscle relaxants, anti-Parkinson drugs) may result in increased anticholinergic adverse effects. Oxycodone should be used with caution and the dosage may need to be reduced in patients using these medications.
Section 4.6 heading has been amended to include Fertility.
Section 4.8
Frequency unknown has been changed to frequency not known.
Lethargy has been added to common side effects.
Hypogonadism has been added to uncommon side effects.
Fatigue has been added to common side effects.
Drug withdrawal syndrome neonatal has been added to frequency not known side effects.
The following has been added:
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie
Section 5.1
The following has been added:
Gastrointestinal System
Opioids may induce spasm of the sphincter of Oddi.
Updated on 10 August 2015
Reasons for updating
- Change of contraindications
- Change to instructions about overdose
- Change to side-effects
Updated on 30 July 2014
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- 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 4.7 - Effects on ability to drive and use machines
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warning and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
Updated on 03 June 2014
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to instructions about overdose
- Change to side-effects
Updated on 12 August 2011
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - MA number
- 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
Changed to Mundipharma Pharamceuticals Ltd
Millbank House
Arkle Road
Sandyford
Dublin 18
8. Marketing Authorisation Number now PA 1688/6/3
Updated on 08 August 2011
Reasons for updating
- Change to marketing authorisation holder
Updated on 01 June 2011
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 4.8 - 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
Section 4.4
‘acute’ has been removed before the word alcoholism.
‘Due to an increased perioperative risk of ileus and respiratory depression OxyNorm concentrate should be used with caution pre-operatively and within the first 24 hours post-operatively.’ Has been added
Section 4.5
Words in bold have been added
‘Concurrent administration of quinidine, an inhibitor of cytochrome P450-2D6, resulted in an increase in oxycodone Cmax by 11%, AUC by 13% and t½ elim by 14%; also an increase in the metabolite noroxycodone level was observed. The pharmacodynamic effects of oxycodone were not altered. This interaction may be observed for other potent inhibitors of the cytochrome P450-2D6 enzyme such as paroxetine and fluoxetine. Cimetidine and inhibitors or substrates of cytochrome P450-3A4 such as ketoconazole, voriconazole and erythromycin may inhibit the metabolism of oxycodone.
Section 4.8
(≥ 1/1,000 to <1/100) the word to has been added throughout the section.
Immune system disorders
Frequency unknown symptoms of anaphylactic or analphylatctoid reaction has been changed to read ‘ anaphylactic responses.
Psychiatric disorders:
Uncommon: emotional lability has been changed to read ‘affect lability. Mood altered has been removed.
Nervous system disorders
Common: ‘faintness’ has been removed.
Uncommon: ‘vertigo’ has been removed, dysgeusi, syncope has been added
Ear and labyrinth disorders
‘Vertigo’ has been added
Cardiac disorders
‘syncope’ has been deleted
Gastrointestinal disorders
Uncommon: ‘taste perversion’ has been removed.
Skin and subcutaneous tissue disorders
Common: sweating has been removed and ‘hyperhidrosis ‘ has been added
Reproductive system and breast disorders
Uncommon: ‘impotence’ has been removed and replaced with ‘ erectile dysfunction’
General disorders and administration site conditions
Common: asthenic has been replaced with ‘asthenic conditions’
Section 5.1
The therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative (antiussive has been added).
Updated on 04 May 2011
Reasons for updating
- Change due to user-testing of patient information
Updated on 01 July 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.3 - Contraindications
- 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
- Change to section 5 - Pharmacological properties
- Change to section 5.3 - Preclinical safety data
- 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
"Excipients: Each ml of oral solution contains 0.1 mg sunset yellow (E110)" has been added.
Section 4.3 Contra-indications
"Any situation where opioids are contraindicated" has been added. "Cor pulmonale" has been added. "hypersensitivity to any of the excipients"
Section 4.4 Special warnings and precautions for use
"The major risk of opioid excess is respiratory depression" has been added.
Section has been re-written.
Section 4.5 Interactions with other medicinal products and other forms of interaction
"There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect the CNS such as" has been added.
Section 4.6 Pregnancy and lactation
"OxyNorm concentrate should not be used in pregnancy of the breast feeding mother" has been added.
"Oxycodone penetrates the placenta." has been added.
"Infants born to mothers who have received opioids during pregnancy should be monitored for respiratory depression" has been added.
Section 4.8 Undesirable effects
Section has been re-written.
5.1 Pharmacodynamic properties
Section has been re-written.
5.3 Pre-clinical safety data
Now reads " There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC".
Updated on 11 June 2010
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
Updated on 10 August 2007
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 October 2005
Reasons for updating
- Change to date of revision
- Change of active ingredient
Updated on 16 May 2005
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - 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
- Change to section 4.9 - Overdose
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 May 2005
Reasons for updating
- Change to warnings or special precautions for use
- Change of contraindications
- Change to side-effects
- Change to date of revision
Updated on 27 August 2004
Reasons for updating
- New PIL for medicines.ie
Updated on 03 March 2004
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)