Targin 5/2.5mg, 10mg/5mg, 20mg/10mg and 40/20mg prolonged release tablets

  • Name:

    Targin 5/2.5mg, 10mg/5mg, 20mg/10mg and 40/20mg prolonged release tablets

  • Company:
    info
  • Active Ingredients:

    Naloxone Hydrochloride dihydrate, Oxycodone Hydrochloride

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/07/18

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Summary of Product Characteristics last updated on medicines.ie: 19/6/2019

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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Medicine Name OxyNorm Concentrate Active Ingredients Oxycodone Hydrochloride
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Medicine Name Targin 15 mg/7.5 mg and 30 mg/15 mg prolonged-release tablets Active Ingredients Naloxone Hydrochloride dihydrate, Oxycodone Hydrochloride
1 - 0 of 31 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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 19 June 2019 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 17 July 2018 SmPC

Reasons for 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4

The text in bold has been added to the section below:

‘Caution is advised in patients taking MAO inhibitors or CNS depressants.

Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs:

Concomitant use of opioids, including oxycodone hydrochloride and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Targin concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be aware of these symptoms (see section 4.5).’

The text below has also been added to section 4.4:

‘Opioids such as oxycodone 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 manifest from these hormonal changes.’

total lactase deficiency’ has been added to replace ‘Lapp lactase deficiency’

 

Section 4.5

The text in bold has been added to the first paragraph of section 4.5 and text in strikethrough has been removed:

‘The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4).

Substances having a Drugs which depress the CNS depressant effect include but are not limited to:(e.g. other opioids, anxiolytics, hypnotics and sedatives (including benzodiazepines), hypnotics, antidepressants, antipsychotics, antihistamines and antiemetics.) may enhance the CNS depressant effect (e.g. respiratory depression) of Targin.

 

 Section 4.8

Rare:                    Drug dependence’ added underneath the subheading ‘Psychiatric disorders’

Aggression’ added to ‘Not known’ section beneath ‘Psychiatric disorders’

‘Drug dependence’ and ‘aggression’ removed from the Psychiatric disorders’ subheading within the section ‘For the active substance oxycodone hydrochloride….’

‘Drug dependence’ and Aggression’ added to ‘Not known’ section beneath ‘Psychiatric disorders’ under ‘Undesirable effects in the treatment of restless legs syndrome’

 

 

Section 5.1

‘Opioids such as oxycodone 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 manifest from these hormonal changes.’

The text above has been replaced with this text: ‘For effects of opioids upon the endocrine system, see section 4.4’

Section 10

The date of revision was updated to ‘June 2018’

Updated on 17 July 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 28 March 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 March 2017 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 31 January 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 31 January 2017 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 March 2016 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

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 October 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

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 9 October 2015 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 24 April 2015 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 16 April 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration

Updated on 8 August 2014 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 7 June 2013 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 29 May 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions
  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 7 February 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

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 January 2012 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

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 9 January 2012 PIL

Reasons for updating

  • Change of licence holder
  • Change to date of revision

Updated on 19 August 2011 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 15 August 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 3 May 2011 SmPC

Reasons for updating

  • Introduction of new strength

Legal category: Product subject to medical prescription which may not be renewed (A)

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 3 May 2011 PIL

Reasons for updating

  • Introduction of new strength

Updated on 5 July 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 14 May 2010 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to ATC code in section 5.1

Updated on 7 April 2010 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

There are extensive changes throughout the sections listed.

Updated on 24 March 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to further information section

Updated on 15 March 2010 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 28 August 2009 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 21 August 2009 PIL

Reasons for updating

  • New PIL for new product