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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories
Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland
Telephone: +353 1 206 3800
Fax: +353 1 294 5104
Medical Information e-mail: info@mundipharma.ie
Summary of Product Characteristics last updated on medicines.ie: 12/08/2011
SPC OxyNorm Concentrate

When a pharmaceutical company changes an SPC or PIL, 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 12/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2011
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 01/06/2011 and displayed until 12/08/2011
Reasons for adding or 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
Date of revision of text on the SPC:   01-Apr-2011
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 01/07/2010 and displayed until 01/06/2011
Reasons for adding or 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
Date of revision of text on the SPC:   01-Feb-2010
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 10/08/2007 and displayed until 01/07/2010
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 16/05/2005 and displayed until 10/08/2007
Reasons for adding or 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
Updated on 03/03/2004 and displayed until 16/05/2005
Reasons for adding or 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
Updated on 26/06/2003 and displayed until 03/03/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Oxycodone Hydrochloride