Targin 15 mg/7.5 mg and 30 mg/15 mg prolonged-release tablets

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/05/20

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Summary of Product Characteristics last updated on medicines.ie: 15/5/2020

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Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

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Company Products

Medicine NameActive Ingredients
Medicine Name Adizem-SR Capsules Active Ingredients Diltiazem Hydrochloride
Medicine Name ADIZEM-XL Capsules Active Ingredients Diltiazem Hydrochloride
Medicine Name BuTrans 15 microgram/hour transdermal patches Active Ingredients Buprenorphine
Medicine Name BuTrans transdermal patches Active Ingredients Buprenorphine
Medicine Name Flutiform 50 microgram/5 microgram, 125 microgram/5 microgram and 250 micorgram/10 microgram per metered dose pressurised inhalation, suspension. Active Ingredients Fluticasone Propionate, Formoterol fumarate dihydrate
Medicine Name Flutiform K-haler 50 microgram /5 microgram, 125 microgram /5 microgram per actuation pressurised inhalation, suspension. Active Ingredients Fluticasone Propionate, Formoterol fumarate dihydrate
Medicine Name Herzuma 150 mg and 420 mg powder for concentrate for solution for infusion Active Ingredients Trastuzumab
Medicine Name Invokana 100 mg and 300 mg film-coated tablets Active Ingredients Canagliflozin hemihydrate
Medicine Name MST Continus Suspension Active Ingredients Morphine sulfate
Medicine Name MST Continus Tablets Active Ingredients Morphine sulfate
Medicine Name Nyxoid 1.8 mg nasal spray Active Ingredients Naloxone Hydrochloride dihydrate
Medicine Name OxyContin prolonged release tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 10 mg/ml solution for Injection or Infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm 50 mg/ml, solution for injection or infusion Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Capsules Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Concentrate Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm Dispersa 5, 10, 20 mg orodispersible tablets Active Ingredients Oxycodone Hydrochloride
Medicine Name OxyNorm liquid 1 mg/ml oral solution Active Ingredients Oxycodone Hydrochloride
Medicine Name PALLADONE Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Palladone SR Capsules Active Ingredients Hydromorphone Hydrochloride
Medicine Name Pelmeg 6 mg solution for injection in pre-filled syringe Active Ingredients Pegfilgrastim
Medicine Name PHYLLOCONTIN CONTINUS Tablets Active Ingredients Aminophylline Hydrate
Medicine Name SEVREDOL Tablets Active Ingredients Morphine sulfate
Medicine Name Targin 15 mg/7.5 mg and 30 mg/15 mg prolonged-release tablets Active Ingredients Naloxone Hydrochloride dihydrate, Oxycodone Hydrochloride
Medicine Name Targin 5/2.5mg, 10mg/5mg, 20mg/10mg and 40/20mg prolonged release tablets Active Ingredients Naloxone Hydrochloride dihydrate, Oxycodone Hydrochloride
1 - 0 of 30 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 15 May 2020 PIL

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 SmPC

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 7 August 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

Updated on 7 August 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….’

 

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 SmPC

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 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 4 May 2016 SmPC

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 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 March 2016 PIL

Reasons for updating

  • New PIL for new product