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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: 17/08/2011
SPC Targinact 5 mg/2.5 mg, 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg 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 17/08/2011 and displayed until Current
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 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Aug-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.4

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

Section 4.5

"alcohol" has been deleted from " Substances having a CNS-depressant effect (e.g. alcohol, other opiods, sedatives .........

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

Section 4.7

"alcohol" has been deleted from  "This is particularly likely at the beginning of treatment with Targinact, after dose increase or product rotation and if Targinact is combined with alcohol or other CNS depressant agents.
Updated on 18/01/2011 and displayed until 17/08/2011
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The shelf life of the 5/2.5mg has changed from 2 tears to 3 years.
Updated on 01/07/2010 and displayed until 18/01/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The following sentence has been deleted " For doses not realisable/practicable with this strength other strengths of this medicincal product are available"

This was removed as the sentence does not make sense for a combined SPC including all the strengths.
Updated on 06/04/2010 and displayed until 01/07/2010
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   YES

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

Active Ingredients/Generics

 
  oxycodone hydrochloride
  naloxone hydrochloride dihydrate