Home | About the eMC | Help | Mobile
eMC - trusted, up to date and comprehensive information about medicines
Link to eMC medicine guides website
eMC homepage
Advanced search
Get Medicines Compendium UK app here

Napp Pharmaceuticals Limited
Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW
Telephone: +44 (0)1223 424 444
Fax: +44 (0)1223 424 441
WWW: http://www.napp.co.uk
Medical Information Fax: +44 (0)1223 424 912

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 26/05/2011
SPC OxyContin tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 26/05/2011 and displayed until Current
Reasons for adding or 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 5.3 - Preclinical Safety Data
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-May-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2
    "OxyContin tablets should not be taken with alcoholic drinks." has been removed.

    Section 4.4
    "Intake of OxyContin tablets with alcoholic drinks should be avoided because this may lead to more frequent undesirable effects such as somnolence and respiratory depression (See Section    
    4.5) has been removed.

    "In vitro data have demonstrated that the release rate of oxycodone from the OxyContin formulation is maintained in varying concentrations of ethanol.  Therefore, patients already established
    on an alcohol resistant prolonged release formulation of oxycodone should not be switched to an alternative alcohol susceptible formulation of oxycodone." has been removed.

    

"Concomitant use of alcohol and OxyContin may increase the undesirable effects of OxyContin; concomitant use should be avoided." has been added. 

 

 Section 4.5

  "alcohol" has been removed from the first sentence.

   "Alcohol may enhance the pharmacodynamic effects of OxyContin; concomitant use should be avoided." has been added.


    Section 5.3

    "In vitro dissolution data generated using the standard dissolution method, show that in the presence of ethanol, at concentrations up to 40%, the prolonged release characteristics of 
    the OxyContin formulation were maintained and no breakdown of the prolonged release mechanism was observed." has been removed.

Updated on 12/11/2010 and displayed until 26/05/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic 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-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 1
‘film coated’ has been deleted
Section 3
‘film coated’ has been deleted
Section 4.2
‘OxyContin tablets should not be taken with alcoholic drinks.’ Has been added.

OxyContin tablets must be swallowed whole, and not broken, chewed or crushed.  Underlined words have been added.

‘There were no studies in patients below 18 years of age, therefore’ has been deleted.

Section 4.3

‘chronic bronchial asthma’ has been changed to read ‘ severe bronchial asthma’.
Section 4.4

Intake of OxyContin tablets with alcoholic drinks should be avoided because this may lead to more frequent undesirable effects such as somnolence and respiratory depression (see Section 4.5).

‘OxyContin tablets, like all opioids, should be used with particular care’ now reads’

‘OxyContin tablets, like all opioids should be avoided’

Section 4.5

‘voriconazole’ has been added

Section 4.8

‘Thinking disturbances’ now reads Thinking abnormal.  ‘Visual disturbance’ now reads ‘Vision abnormal’

‘Dental caries’ and ‘Cholestasis’ has been added.  ‘Asthenia’ now reads ‘ Asthenic conditions’.

Section 4.9

‘hallucinations’ has been added.

‘The effects of overdosage will be potentiated by the simultaneous ingestion of alcohol or other psychotropic drugs.’ has been added.

‘The patient should be observed for at least 6 hours after the last dose of naloxone.’ has been added.

Section 5.1
‘anititussive’ has been added to second paragraph.

‘Endocrine system

Opioids may influence the hypothalamic-pituitary-adrenal or – gonadal axes.  Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone.  Clinical symptoms may be manifest from these hormonal changes.

Other pharmacological effects

In- vitro and animal studies indicate various effects of natural opioids, such as morphine, on components of the immune system; the clinical significance of these findings is unknown.  Whether oxycodone, a semisynthetic opioid, has immunological effects similar to morphine is unknown.’ has been added.

Section 5.3

Has been rewritten.

 
Updated on 04/12/2008 and displayed until 12/11/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.3 - Preclinical Safety Data
Date of revision of text on the SPC:   01-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4  additional paragraph has been added:

In-vitro data have demonstrated that the release rate of oxycodone from the OxyContin formulation is maintained in varying concentrations of ethanol. Therefore, patients already established on an alcohol-resistant prolonged release formulation of oxycodone should not be switched to an alternative alcohol-susceptible formulation of oxycodone. As with all opioids, concomitant administration of alcohol is not recommended due to the increased CNS depressant effects (see also section 4.5 and 5.3).


Section 5.3 additional paragraph has been added:

In vitro dissolution data generated using the standard dissolution method, show that in the presence of ethanol, at concentrations up to 40%, the prolonged release characteristics of the OxyContin formulation were maintained and no breakdown of the prolonged release mechanism was observed.

 
Updated on 30/10/2008 and displayed until 04/12/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 4.4 and 4.8 have been re-written
Updated on 05/06/2007 and displayed until 30/10/2008
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   04/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
5.1  Pharmacodynamic Properties:
 
Clinical studies (paragraph has been changed to read:)
 
 The efficacy of OxyContin tablets has been demonstrated in cancer pain, post-operative pain and severe non-malignant pain such as diabetic neuropathy, postherpetic neuralgia, low back pain and osteoarthritis. In the latter indication, treatment was continued for up to 18 months and proved effective in many patients for whom NSAIDs alone provided inadequate relief. The efficacy of OxyContin tablets in neuropathic pain was confirmed by three placebo-controlled studies.

In patients with chronic non-malignant pain, maintenance of analgesia with stable dosing was demonstrated for up to three years.
Updated on 07/12/2006 and displayed until 05/06/2007
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   03/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Removal of the black triangle
Updated on 15/07/2005 and displayed until 07/12/2006
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 9 - Date of Renewal of Authorisation
  • Change to section 10 (date of (partial) revision of the text
Updated on 21/05/2004 and displayed until 15/07/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
  • Addition of Black Triangle
Updated on 12/05/2003 and displayed until 21/05/2004
Reasons for adding or updating:
  • Removal of Black Triangle
Updated on 25/09/2002 and displayed until 12/05/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Correction of spelling/typing errors
Updated on 10/06/2002 and displayed until 25/09/2002
Reasons for adding or updating:
  • Addition of new strength
Updated on 01/02/2002 and displayed until 10/06/2002
Reasons for adding or 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 10 (date of (partial) revision of the text
Updated on 28/08/2001 and displayed until 01/02/2002
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 24/03/2000 and displayed until 28/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  oxycodone hydrochloride