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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 15 mg, 30 mg, 60 mg, 120mg prolonged release 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 02/03/2011 and displayed until 26/05/2011
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  oxycodone hydrochloride