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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: 31/08/2011
SPC OxyNorm Capsules

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 31/08/2011 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-Aug-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company
            7.  MA holder is now

     

Mundipharma Pharmaceuticals Limited

Millbank House

Arkle Road

Sandyford

Dublin 18

8.  Marketing Authorisation numbers are now

PA 1688/6/4-6
Updated on 11/05/2011 and displayed until 31/08/2011
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 11/05/2011
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 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
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 " Excipients: Each 5 mg capsule contains 0.019 mg sunset yellow (E110)" has been added.
Section 4.3 "Any situation where opioids are contraindicated:" has been added.
"Chronic has been replaced with "severe"
"cor pulmonale" has been added
"hypersensitivity to any of the excipients" has been added.
Section 4.4
"The major risk of opioid excess is respiratory depression" has been added
"severely impaired pulmonary function" has been added
Paragraph 3 has been rewritten
Paragraph 5 onwards has been re-written.
Section 4.5
"There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect the CNS such as" has been added.
other opioids, neuroleping drugs" has been added
"CYP2D6 and CYP3A4 have been added.
Section 4.6
"OxyNorm capsules should not be used in pregnancy or the breast feeding mother" has been added (changed from not recommended)
Section 4.8
 Has been re-written
Section 5.1 and 5.3 has been rewritten
Section 6
Sodium dodecylsulphate has been changed to Sodium laurilsulfate
Updated on 31/07/2007 and displayed until 01/07/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   07/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Section 6.1 capsule ink excipients updated
Section 10  revision date updated
Updated on 26/10/2005 and displayed until 31/07/2007
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.4 - Special precautions for storage
  • 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
Updated on 17/05/2005 and displayed until 26/10/2005
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 17/05/2005
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 23/06/2003 and displayed until 03/03/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Oxycodone Hydrochloride