OxyNorm 10 mg/ml solution for Injection or Infusion *
Pharmacy Only: Prescription

Updated on 16 March 2022

File name

pil 10 mgml_1647438364.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_1647438264.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_1624545629.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_1624545554.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_1554304631.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_1554304566.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_1541426111.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_1541424902.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

$0Section 4.4$0$0Addition of ‘benzodiazepines,other CNS depressants (including alcohol) or ‘ $0$0Textregarding opioids has been added to section 4.4 – $0$0‘Opioids, such as oxycodone hydrochloride,may influence the hypothalamic-pituitary-adrenal or –gonadal axes. Some changesthat can be seen include an increase in serum prolactin, and decreases inplasma cortisol and testosterone. Clinical symptoms may manifest from thesehormonal changes.’ $0$0 $0$0Section 4.5$0$0The words inbold have been added to or moved within this part of section 4.5.$0$0‘There can be an enhanced CNS depressanteffect, which can result in profoundsedation, respiratory depression, coma and death, during concomitanttherapy with benzodiazepines or otherdrugs which affect the CNS such as alcohol,other opioids, non-benzodiazepine sedatives, hypnotics, antidepressants, phenothiazines, anaesthetics, musclesrelaxants, neuroleptic drugs, antihypertensives and SSRIs.’ $0$0 $0$0Section 5.1$0$0The text below ‘EndocrineSystem’ has been replaced with ‘See section4.4’ $0$0 $0$0Section 10$0$0The date of revision has been updated to read ‘November 2017’$0

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

The following sections have been re-written

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

6.3 Shelf Life

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

MA Holder has been changed to

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

            Section 2.2 now reads

              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

TSection 4.4 additional text : his medicine contains less than 1mmol sodium (23 mg) per 1 ml, so it is essentially sodium-free

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