We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

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: 07/06/2013
SPC Targin 5/2.5mg, 10mg/5mg, 20mg/10mg and 40/20mg prolonged release tablets

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 07/06/2013 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   01-Apr-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

1.  Black triangle has been removed.

2.  Qualiative and Quantitative Composition

     5 mg/2.5 mg  - dihydrate equivalent changed from to 2.5mg, naloxone hydrochloride and 2.5 mg naloxone.

4.2  Posology and method of administration

       For patients requiring higher doses of Targinact, administration of supplemental prolonged‑release oxycodone hydrochloride at the same time intervals should be considered, taking into account the maximum daily dose of 400 mg prolonged-release oxycodone hydrochloride.  (text in red has been added)

Children and adolescents (under 18 years) Paediatric population

The safety and efficacy of Targinact in children below 18 years has not been established.  No data are available.

Targinact is not recommended for use in children and adolescents below the age of 18 years due to a lack of data on safety and efficacy.

Text with strike-through has been deleted, text in red has been added.

4.3  Contraindications

excipients
listed in section 6.1 (text in red has been added)

4.4  Special warnings and precautions for use

The major risk from of  opioids
excess is respiratory depression.

Section 4.5  Interaction with other medicinical products and other forms of interaction

This section has been re-written.

4.6    Fertility, Pregnancy and lactation

The heading lactation has been replaced with Breastfeeding.

Fertility

There are no data with respect to fertility.

Text in red has been added.

4.8  Undesirable
effects

There have been many changes and additions throughout this section.

5.2  Pharmacokinetic
properties

The heading Metabolism has been replaced with Biotransformation.

In vitro studies suggest that therapeutic doses of cimetidine are not likely to significantly influence the production of noroxycodone. has been removed

The heading Metabolism and elimination has been replaced with Biotransformation and elimination.



Updated on 07/02/2013 and displayed until 07/06/2013
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   01-Jan-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 6.3 Shelf Life

Polyvinylchloride/aluminium foil blisters: 3years
HDPE bottles: 2 years

has been added.

"3 years" has been deleted
Updated on 19/01/2012 and displayed until 07/02/2013
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-Dec-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 7

MA Holder changed to Mundipharma Pharmaceuticals Limited
                                 Millbank House
                                  Arkle Road
                                  Sandyford
                                  Dublin 18
                                  Ireland

Section 8

New MA Number PA 1688/10/2
Updated on 19/08/2011 and displayed until 19/01/2012
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 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 be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.4

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

Section 4.5

"Alcohol may enhance the pharmacodynamic effects of Targin; concomitant use should be avoided". has been added.
Updated on 03/05/2011 and displayed until 19/08/2011
Reasons for adding or updating:
  • Introduction of new strength
Date of revision of text on the SPC:   26-Apr-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

New strengths of 5/2.5mg and 40/20mg have now been launched in Ireland. Title of document updated to include all 4 strengths
Updated on 14/05/2010 and displayed until 03/05/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Apr-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Change to ATC code in section 5.1
Updated on 07/04/2010 and displayed until 14/05/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Mar-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

There are extensive changes throughout the sections listed.
Updated on 28/08/2009 and displayed until 07/04/2010
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

None provided

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share