Targin 15 mg/7.5 mg prolonged-release tablets

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Pharmacy Only: Prescription

Updated on 07 June 2024

File name

PIL Targin Prolonged Release Tablets 15-7.5-30-15mg - clean - UPDATED [PLX Error Sec.6].pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 09 May 2024

File name

PIL Targin Prolonged Release Tablets 15-7.5-30-15mg - clean- sept 2023.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 09 May 2024

File name

Targin Prolonged Release Tablets-15-7.5mg-clean-sept 2023.pdf

Reasons for 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Updated on 07 June 2023

File name

Patient Leaflet-PIL English Targin Prolonged Release Tablets 15-7.5-30-15mg - clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 07 June 2023

File name

Targin Prolonged Release Tablets-SmPC-15-7.5mg-clean.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Updated on 06 April 2023

File name

Targin Prolonged Release Tablets 15-7.5mg-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Updated on 06 April 2023

File name

Patient Leaflet-PIL English Targin Prolonged Release Tablets 15-7.5-30-15mg - clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 April 2021

File name

pil 15-7.5, 30-15.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Section 2 - Update to warning on use of MAOIs to include 2 week period. Addition of warning regarding sleep apnoea. Addition of warning on increased sensitivity to pain.

Section 4 - Addition of sleep apnoea as a possible side effect.

Section 6 - Deletion of UK manufacturer following Brexit.

Updated on 21 April 2021

File name

spc-15-7.5, 30-15.pdf

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

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 - Reorganisation of warnings into bullet point format. Addition of warnings on respiratory depression and sleep-related breathing disorders. Addition of warning advising caution in use for patients taking MAOIs or who have received MAOIs within the previous two weeks. Addition of warning regarding hyperalgesia.

Section 4.5 - Clarification of warning advising caution in use for patients taking MAOIs or who have received MAOIs within the previous two weeks.

Section 4.8 - Addition of sleep apnoea as a potential undesirable effect. Correction of anaphylactic responses to anaphylactic reaction.

Updated on 15 May 2020

File name

pil-15-7.5-30-15.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Free text change information supplied by the pharmaceutical company

Addition of warnings in section 2 regarding concomitant use of serotonin agents and gabapentinoids with Targin

Updated on 15 May 2020

File name

spc-15-7.5, 30-15.pdf

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

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

Free text change information supplied by the pharmaceutical company

Addition of warnings in section 4.5 regarding concomitant use of serotonin agents and gabapentinoids with Targin

Updated on 07 August 2018

File name

Package_leaflet_highlighted_Prolonged_Release_Tablets_English_Targin 15_7.5 30_15 correction.pdf

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

Updated on 07 August 2018

File name

IPHA_SPC_clean_Prolonged_Release_Tablets_English_Targin_15_75_30_15_mg.pdf

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….’

 

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 31 January 2017

Reasons for updating

  • New SPC for new product

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

Updated on 31 January 2017

Reasons for updating

  • 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 4.7 - 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 6.5 - 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 the SPC: in italics
Added text: in the colour red
Removed text: crossed through

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

Targin 15/7.5 mg:
Each prolonged-release tablet contains 15 mg of oxycodone hydrochloride equivalent to 13.5 mg oxycodone and 7.5 mg naloxone hydrochloride as 8.24 mg of naloxone hydrochloride dihydrate equivalent to 7.5 mg naloxone hydrochloride and 6.75 mg naloxone.

Targin 30/15 mg:
Each prolonged-release tablet contains 30 mg of oxycodone hydrochloride equivalent to 27 mg oxycodone and 15 mg naloxone hydrochloride as 16.48 mg of naloxone hydrochloride dihydrate equivalent to 15 mg naloxone hydrochloride and 13.5 mg naloxone.

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

Targin 15/7.5 mg: Each prolonged-release tablet contains 52.97 53.0 mg lactose anhydrous.

Section 4.2:
The wording has been amended: the trade name 'Targin' has been replaced by 'these tablets' or by 'these prolonged-release tablets'.

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

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.

During long-term administration, the patient may develop tolerance to the medicinal product and require higher doses to maintain the desired analgesic effect.

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:
The spelling of 'Povidone K30' has been corrected from 'Providone'.

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
Not all pack sizes may be marketed

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

Updated on 04 May 2016

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

Section 3 Targin 15/30 should read Targin 15/7.5

Updated on 22 March 2016

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 March 2016

File name

PIL_16669_297.pdf

Reasons for updating

  • New PIL for new product