OxyNorm liquid 1 mg/ml oral solution

  • Name:

    OxyNorm liquid 1 mg/ml oral solution

  • 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

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 3/4/2019

Click on this link to Download PDF directly

Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

mundi_logo

Company Products

Medicine NameActive Ingredients
Medicine Name Adizem-SR Capsules Active Ingredients Diltiazem Hydrochloride
Medicine Name ADIZEM-XL Capsules Active Ingredients Diltiazem Hydrochloride
Medicine Name BuTrans 15 microgram/hour transdermal patches Active Ingredients Buprenorphine
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
Medicine Name Herzuma 150 mg and 420 mg powder for concentrate for solution for infusion Active Ingredients Trastuzumab
Medicine Name Invokana 100 mg and 300 mg film-coated tablets Active Ingredients Canagliflozin hemihydrate
Medicine Name Levact 25mg and 100 mg powder for concentrate for solution for infusion Active Ingredients Bendamustine Hydrochloride
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
  • 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 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-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 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

  • 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 ‘Seesection 4.4’ $0$0 $0$0Section 10$0$0The date of revision has been updated to read ‘November 2017’$0

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 31 October 2016 PIL

Reasons for updating

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

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 4.6 - 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 PIL

Reasons for updating

  • 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
  • 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
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation

Updated on 8 March 2012 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

Section 7 Marketing Authorisation Holder

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 8 February 2012 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 7 June 2011 SmPC

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

Section 4.4

 '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 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 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 4.3 Contra-indications
"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 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 14 May 2010 SmPC

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

None provided

Updated on 22 April 2010 PIL

Reasons for updating

  • New PIL for medicines.ie