OxyNorm 10 mg/ml solution for Injection or Infusion
*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 10 mgml Injection 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 5.3 - 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
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 10 mgml Injection 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
- 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 10 mgml Injection SPC - Ireland-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 10 mgml Injection PIL - Ireland-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 10 mgml Injection 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 10 mgml Injection PIL-IE-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 16 March 2022
File name
pil 10 mgml.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Section 2 - Addition of warning regarding constipation. Addition of warning regarding sleep apnoea. Update to excipient warnings. Minor editorial updates.
Section 4 - Addition of sleep apnoea as a possible side effect.
Updated on 16 March 2022
File name
spc 10 mgml.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 concomitant use of MAOIs. Update to warnings regarding sodium content. Editorial updates.
Section 4.6 - Update to 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 10mgml.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
- Change to section 6 - manufacturer
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.
Section 6 - Manufacturer - Deletion of UK manufacturer following Brexit.
Updated on 24 June 2021
File name
spc 10mgml.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 conversion from morphine.
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.
Section 5.3 - Addition of preclinical data from company core datasheet.
Updated on 03 April 2019
File name
Approved_package_leaflet_clean_Solution_for_Injection_or_Infusion_OxyNorm_10_mg_ml_serotonergic_med_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_Solution_for_Injection_or_Infusion_English_OxyNorm_10mg_ml_serotonergic_medicines_ie.pdf
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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
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-cleanoxynorm10mgmlsfoen_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 in relation to use of opiods with 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, phenothiazines, 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_11924_159.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 20 July 2016
Reasons for updating
- Change to MA holder contact details
- Change to name of manufacturer
Updated on 14 August 2015
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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
The following headings has been deleted/moved
Route of administration
Subcutaneous injection or infusion
Intravenous injection or infusion
Children under 18 years has been deleted and Paediatric population has been added
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
Text in red with strike through has been deleted:
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 4.8
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 4.9
Text in red has been added
Acute overdose with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, hypotonia, miosis, bradycardia, hypotension, pulmonary oedema and death.
Section 5.1
Text in red 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
- Change to name of manufacturer
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
- 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
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
Updated on 06 March 2013
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
3 years upopened has been changed to 5 years unopened
Updated on 05 April 2012
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.1 - Therapeutic indications
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.2 - Incompatibilities
- Change to section 6.5 - Nature and contents of container
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 9 - Date of renewal of authorisation
- 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 2
Oxycodone hydrochloride 10 mg/ml (equivalent to 9 mg of oxycodone base). "base" has been added.
Section 4.1
"OxyNorm injection is indicated in adults only" has been added.
Section 4.2
Prescribers should consider concomitant treatment with antiemetics and laxatives for the prevention of nausea, vomiting and constipation.
The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication.
Discontinuation of treatment:
When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
Adults and elderly:
The following starting doses are recommended for opioid-naïve patients. The initial dose should be adjusted to previous or concurrent medication (especially if the patient has been treated with other opioids before), the total condition of the patient, and the severity of pain.
Wording in red has been added.
Section 4.3
Any situation where opioids are contraindicated: Severe respiratory depression with hypoxia, head injury, paralytic ileus, acute abdomen, delayed gastric emptying, severe obstructive airways disease, severe bronchial asthma, cor pulmonale, hypercarbia, known sensitivity to oxycodone, morphine or other opioids, hypersensitivity to any of the excipients, acute hepatic disease, concurrent administration of monoamine oxidase inhibitors (see section 4.5) or within 2 weeks of discontinuation of their use. or in any situation where opioids are contraindicated.
Changes marked in red.
Section 4.4
Has been re-written
Section 4.5
Has been re-written
Section 4.6
Has been re-written
Section 4.8
Has been re-written/formatted
Section 4.9
Overdosage has been changed to Overdose
Section 5.1
Has been re-written
Section 5.3
Has been re-written
Section 6.2
Has been re-written
Section 6.5
Has been re-written
Section 6.6
The following has been added
No evidence of incompatibility was observed between OxyNorm injection and representative brands of injectable forms of the following drugs, when stored in high and low dose combinations in polypropylene syringes over a 24 hour period at ambient temperature.
Hyoscine butylbromide
Hyoscine hydrobromide
Dexamethasone sodium phosphate
Haloperidol
Midazolam hydrochloride
Metoclopramide hydrochloride
Levomepromazine hydrochloride
Glycopyrronium bromide
Ketamine hydrochloride
Updated on 01 June 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
Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland
MA Number has been changed to
PA 1688/006/001
Updated on 04 March 2011
Reasons for updating
- Change to MA holder contact details
Updated on 07 April 2010
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.4 - Special precautions for storage
- Change to section 6.6 - Special precautions for disposal and other handling
- 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
Oxycodone hydrochloride 10 mg/ml (equivalent to 9 mg of oxycodone).
Each 1 ml ampoule contains 10 mg of Oxycodone hydrochloride.
Each 2 ml ampoule contains 20 mg of Oxycodone hydrochloride (10 mg/ml).
This medicinal product contains 0.121 mmol sodium (2.78 mg) per ml.
For a full list of excipients, see section 6.1.
Section 4.4 last paragraph has been changed to read
This medicinal product contains 0.121 mmol sodium (2.78 mg) per ml. To be taken into consideration by patients on a controlled sodium diet.
Section 6.4 has been changed to read
This medicinal product does not require any special temperature storageconditions. Store in the original package in order to protect from light. For further information on use after opening see section 6.6.
Section 6.6 First new paragraph now reads:
Each ampoule is for single use in a single patient. The injection should be given immediately after opening the ampoule, andany unused portion should be discarded. Chemical and physical in-use stability has been demonstrated for 24 hours at 15 – 25°C room temperature.
Updated on 08 December 2009
Reasons for updating
- Change due to user-testing of patient information
Updated on 01 July 2009
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
Updated on 02 April 2007
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 02 April 2007
Reasons for updating
- New PIL for new product