OxyNorm liquid 1 mg/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 23 May 2024
File name
Proposed_IE_SmPC_OxyNorm_Oral solution_1mg-ml_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_Oral solution_1mg-ml_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 Liquid 1 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 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 08 August 2023
File name
OxyNorm Liquid 1 mgml SPC - Ireland_v1.0-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 Liquid 1 mgml SPC - Ireland_v1.0-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 Liquid 1 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 Liquid 1 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 Liquid 1 mgml PIL-IE-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 16 March 2022
File name
pil liq.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- 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. Addition of excipient warnings. Minor editorial updates.
Section 4 - Addition of sleep apnoea as a possible side effect.
Updated on 16 March 2022
File name
spc liq.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 addition of sodium warnings.
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 - Update to statement regarding human data on fertility. Editorial updates.
Section 4.8 - Addition of sleep apnoea as a possible side effect.
Updated on 24 June 2021
File name
pil liq.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 liq.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_Liquid_1_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_Liquid_1mg_ml_serotonergic_medcines_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-cleanoxynormliquid1mgmlosoen_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-cleanoxynormliquid1mgmlosoen_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-benzodiazepines 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_14662_981.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 - manufacturer
- Change to section 6 - date of revision
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 4.6 - Pregnancy and lactation
- 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
Added the following heading:
Conversion from oral morphine
Text in red has been added:
Adults under 20 years and paediatric population
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.
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 SystemOpioids may induce spasm of the sphincter of Oddi.
Updated on 10 August 2015
Reasons for updating
- 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
- 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
- Change to drug interactions
- Change to information about drinking alcohol
- Change to information about pregnancy or lactation
Updated on 08 March 2012
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
is now:
Mundipharma Pharmaceuticals Limited
Millbank House
Arkle Road
Sandyford
Dublin 18
Ireland
Section 8 Marketing Authorisation Number is
PA 1688/006/002
Updated on 08 February 2012
Reasons for updating
- Change to marketing authorisation holder
Updated on 07 June 2011
Reasons for updating
- 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
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- 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
'acute' has been deleted before 'alcoholism'
"Due to an increased perioperative risk of ileus and respiratory depression OxyNorm liquid should be used with caution pre-operatively and within the first 24 hours post-operatively." has been added.
Section 4.5
'the metabolite' has been added before 'noroxycodone level'
'voriconazole' has been added
Section 4.8
'to' has been added between (≥ 1/1,000 to <1/100)
hperhidrosis' has been added to common under skin and subcutaneous tissue disorders
'erectile disfunction' has been added and impotence deleted under reproductive system and breast disorders uncommon
'conditions' has been added after asthenic under general disorders and administration site conditions common
Section 4.9
Immune system disorders - anaphylactic responses has replaced symptoms of anaphylactoid reaction
Psychiatric disorders - confusional state has replaced confusion
affect lability has been changed, emotional and mood altered has been deleted
Nervous system disorders - Uncommon
dygeusia, syncope has been added, faintness, vertigo has been deleted.
Ear and labyrinth disorders - vertigo has been added.
Gastrointenstinal disorders
taste perversion has been deleted.
Section 5.1
antitussive has been added in the first sentence.
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 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
"Any situation where opioids are contraindicated" has been added. "Cor pulmonale" has been added, "hypersensitivity to any of the excipients" has been added.
Section 4.4 Special warnings and precautions for use
"The major risk of opioid excess is respiratory depression" Section has been re-written
Section 4.5 Interactions with other medicinal products and other forms of interaction
Section has been re-written.
Section 4.6 Pregnancy and lactation
"OxyNorm liquid should not be used in pregnancy or the breast feeding mother" has been added. "Oxycodone penetrates the placents" 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.
Section 5.1 Pharmacodynamic properties
Section has been re-written.
Section 5.3
Has been changed to read " 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 to side-effects
Updated on 14 May 2010
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 22 April 2010
Reasons for updating
- New PIL for medicines.ie