OxyNorm Concentrate

  • Name:

    OxyNorm Concentrate

  • Company:
    info
  • Active Ingredients:

    Oxycodone Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/04/19

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Summary of Product Characteristics last updated on medicines.ie: 3/4/2019

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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Company Products

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Medicine Name ADIZEM-XL Capsules Active Ingredients Diltiazem Hydrochloride
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Medicine Name BuTrans transdermal patches Active Ingredients Buprenorphine
Medicine Name Flutiform 50 microgram/5 microgram, 125 microgram/5 microgram and 250 micorgram/10 microgram per metered dose pressurised inhalation, suspension. Active Ingredients Fluticasone Propionate, Formoterol fumarate dihydrate
Medicine Name Flutiform K-haler 50 microgram /5 microgram, 125 microgram /5 microgram per actuation pressurised inhalation, suspension. Active Ingredients Fluticasone Propionate, Formoterol fumarate dihydrate
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Medicine Name Invokana 100 mg and 300 mg film-coated tablets Active Ingredients Canagliflozin hemihydrate
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Medicine Name MST Continus Suspension Active Ingredients Morphine sulfate
Medicine Name MST Continus Tablets Active Ingredients Morphine sulfate
Medicine Name Nyxoid 1.8 mg nasal spray Active Ingredients Naloxone Hydrochloride dihydrate
Medicine Name OxyContin prolonged release tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 10 mg/ml solution for Injection or Infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 50 mg/ml, solution for injection or infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Capsules Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Concentrate Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Dispersa 5, 10, 20 mg orodispersible tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm liquid 1 mg/ml oral solution Active Ingredients Oxycodone Hydrochloride
Medicine Name PALLADONE Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Palladone SR Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Pelmeg 6 mg solution for injection in pre-filled syringe Active Ingredients Pegfilgrastim
Medicine Name PHYLLOCONTIN CONTINUS Tablets Active Ingredients Aminophylline Hydrate
Medicine Name SEVREDOL Tablets Active Ingredients Morphine sulfate
Medicine Name Targin 15 mg/7.5 mg and 30 mg/15 mg prolonged-release tablets Active Ingredients Naloxone Hydrochloride dihydrate, Oxycodone Hydrochloride
1 - 0 of 31 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 3 April 2019 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 3 April 2019 SmPC

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 5 November 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 5 November 2018 SmPC

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 7 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 February 2018 PIL

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 6 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 6 February 2018 SmPC

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 31 October 2016 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to section 6 - manufacturer

Updated on 14 August 2015 SmPC

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 PIL

Reasons for updating

  • Change of contraindications
  • Change to instructions about overdose
  • Change to side-effects

Updated on 30 July 2014 SmPC

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

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 3 June 2014 PIL

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 SmPC

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

7.  Marketing Authorisation Holder

Changed to Mundipharma Pharamceuticals Ltd
Millbank House
Arkle Road
Sandyford
Dublin 18

8.  Marketing Authorisation Number now PA 1688/6/3

Updated on 8 August 2011 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 1 June 2011 SmPC

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 4 May 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 1 July 2010 SmPC

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

Section 2 Qualative and Quantative Composition
"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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications

Updated on 10 August 2007 SmPC

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 PIL

Reasons for updating

  • Change to date of revision
  • Change of active ingredient

Updated on 16 May 2005 SmPC

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 PIL

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 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 3 March 2004 SmPC

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 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)