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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland
Telephone: +353 1 206 3800
Medical Information e-mail: info@mundipharma.ie
Summary of Product Characteristics last updated on medicines.ie: 31/01/2017
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 31/01/2017 and displayed until Current
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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jan-2017
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company



Text from SPC: in italics
Added text: coloured in red
Removed test: crossed through

Section 2:
The order of naloxone hydrochloride strengths depiction has been rearranged to a more logical order.

Targin 5 mg/2.5 mg:
Each prolonged-release tablet contains 5 mg of oxycodone hydrochloride equivalent to 4.5 mg oxycodone and 2.5 mg naloxone hydrochloride as 2.73 mg of naloxone hydrochloride dihydrate equivalent to 2.5 mg naloxone hydrochloride and 2.25 mg naloxone.

Targin 10 mg/5 mg:
Each prolonged-release tablet contains 10 mg of oxycodone hydrochloride equivalent to 9 mg oxycodone and 5 mg naloxone hydrochloride as 5.45 mg of naloxone hydrochloride dihydrate equivalent to 5 mg naloxone hydrochloride and 4.5 mg naloxone.

Targin 20 mg/10 mg:
Each prolonged-release tablet contains 20 mg of oxycodone hydrochloride equivalent to 18 mg oxycodone and 10 mg naloxone hydrochloride as 10.9 mg of naloxone hydrochloride dihydrate equivalent to 10 mg naloxone hydrochloride and 9 mg naloxone.

Targin 40 mg/20 mg:
Each prolonged-release tablet contains 40 mg of oxycodone hydrochloride equivalent to 36 mg oxycodone and 20 mg naloxone hydrochloride as 12.8 mg of naloxone hydrochloride dihydrate equivalent to 20 mg naloxone hydrochloride and 18 mg naloxone.

The lactose content has also been revised to one decimal place.

Targin 5 mg/2.5 mg:    Each prolonged-release tablet contains 68.17 68.2 mg lactose anhydrous.
Targin 10 mg/5 mg:     Each prolonged-release tablet contains 61.04 lactose anhydrous.
Targin 20 mg/10 mg:   Each prolonged-release tablet contains 51.78 51.8 lactose anhydrous.
Targin 40 mg/20 mg:   Each prolonged-release tablet contains 103.55 103.6 lactose anhydrous.

Section 3:
'Prolonged-release tablet' has been added as a description of the pharmaceutical form.

Section 4.2:

The wording has been amended: the trade name 'Targin' has been replaced by 'these tablets' or by 'these prolonged-release tablets'.

Text regarding use of Targin 5 mg/2.5 mg for dose titration has been removed.

Targin 5 mg/2.5 mg is intended for dose titration when initiating opioid therapy and individual dose adjustment.

'of Targin' has been removed when referring to doses in this section.

Text has been added regarding elevated peak plasma concentrations.

Slightly elevated (dose corrected) peak plasma concentrations should be taken into account when the 2.5 mg/1.25 mg tablet is used.

Reference to section 4.4 has been added regarding the method of administration.

Targin These tablets must be swallowed whole, and not broken, chewed or crushed (see section 4.4).

Section 4.3:

'Any situation in which opioids are indicated' has been removed.

Section 4.4:
The wording has been amended: the trade name 'Targin' has been replaced by 'these tablets'.

The reference to higher doses has been removed regarding long-term opioid treatment.

In patients under long-term opioid treatment with higher doses of opioids, the switch to Targin can initially provoke withdrawal symptoms.

A cross reference to section 4.2 has been added to provide clarification regarding the occurrence of withdrawal syndrome.

Other minor editorial changes have been made to ensure harmonization across this product range:

A careful Careful medical monitoring is particularly necessary for patients with severe renal impairment.

Section 4.5:
The wording has been amended: the trade name 'Targin' has been replaced by 'these tablets'.

Section 4.6:
The wording has been amended: the trade name 'Targin' has been replaced by 'these tablets'.

Section 4.7:
'with Targin' has been removed in reference to the beginning of treatment.

The wording has been amended: the trade name 'Targin' has been replaced by 'these tables'.

Section 4.8:
The format of this section has changed from tabular form to text.

'Asthenic conditions' has been updated to 'lethargy, fatigue and asthenia'.

The terms 'decreased libido', 'dysgeusia' and 'thirst' have been moved from the undesirable effects section for the single active substance, oxycodone hydrochloride, to the undesirable effects section for pain for the combination product.

For the undesirable effects section for the single active substance, oxycodone hydrochloride, the following changes have been made:

'Hyperalgesia' has been added with a frequency of not known under the classification 'nervous system disorders'.

'Hypogonadism' has been added with a frequency of uncommon under the classification 'reproductive system and breast disorders'.

'Dental caries' has been added with a frequency of not known under the classification 'gastrointestinal disorders'.

The frequency of 'cholestasis' has been updated from not known to uncommon.

'Drug withdrawal system neonatal' has been added with a frequency of not known under the classification 'general disorders and administration site conditions'.

'Aggression' has been added with a frequency of not known under the classification 'psychiatric disorders'.

Section 4.9:
The term 'skeletal muscle flaccidity' has been replaced by 'hypotonia'.

Symptoms of oxycodone overdose include miosis, respiratory depression, somnolence progressing to stupor, skeletal muscle flaccidity hypotonia, bradycardia as well as hypotension.

Section 6.1:
'Hydroxypropylcellulose' has been added as an ingredient of the 5 mg/2.5 mg tablet only.
The description of Povidone K30 has been updated to state that it is an ingredient of the 10 mg/5 mg, 20 mg/10 mg and 40 mg/20 mg tablets only.
The description of Polyvinyl alcohol has been updated
Several colourants have been added as ingredients of the tablet coat for several strengths.

Tablet core:
Ethylcellulose,
Stearyl alcohol,
Lactose monohydrate,
Talc,
Magnesium stearate
,
Hydroxypropylcellulose, (5 mg/2.5 mg tablets only)
Povidone K30
, (10 mg/5 mg, 20 mg/10 mg, 40 mg/20 mg tablets)

Tablet coat:
Poly(vinylalcohol)
, partially hydrolysed,
Titanium dioxide (E171),
Macrogol 3350,
Talc
,
Brilliant Blue FCF aluminium lake (E133), (5 mg/2.5 mg tablets only)
Iron oxide red (E172), (20 mg/10 mg tablets only)
Iron oxide yellow (E172), (40 mg/20 mg tablets only)


Section 6.3:
The descriptions of the packaging components has been updated.
The shelf life after opening has been added for the bottles.

Polyvinylchloride (PVC)/aluminium foil bBlisters: 3 years
HDPE bBottles: 2 years        Shelf life after first opening: 6 months


Section 6.5:

The description of the packaging components and the pack size has been updated.

Child resistant PVC/aluminium foil blisters containing 56 prolonged release tablets.
Pack sizes: 10, 14, 20, 28, 30, 50, 56, 60, 98
Hospital pack: 100 (10 x 10) tablets
HDPE bottles with a child resistant PP closure:
Pack size: 100 tables

Section 10:
The date of revision of the text has been updated to 'January 2017' from 'December 2015'.

Updated on 18/03/2016 and displayed until 31/01/2017
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Dec-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

4.8  Some formatting changes

Undesirable effects in the treatment of restless leg syndrome - Sedation, Speech disorder, Syncope have been added under the heading not known.
Updated on 20/10/2015 and displayed until 18/03/2016
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   01-Sep-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Section 4.2 Highlighted text has been added.

The maximum daily dose has changed to:

The maximum daily dose of Targin is 160 mg oxycodone hydrochloride and 80 mg naloxone hydrochloride.

The prolonged‑release tablets may be taken with or without food with sufficient liquid. Targin must be swallowed whole, and not broken, chewed or crushed.

Updated on 24/04/2015 and displayed until 20/10/2015
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Apr-2015
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company

Changes throughout the document due to addition of a new indication - Restless Leg Syndrome
Updated on 07/06/2013 and displayed until 24/04/2015
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

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