Targin 60 mg/30 mg and 80 mg/40 mg prolonged-release tablets

  • Name:

    Targin 60 mg/30 mg and 80 mg/40 mg prolonged-release tablets

  • Company:
    info
  • Active Ingredients:

    Naloxone Hydrochloride, 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

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 19/6/2019

Click on this link to Download PDF directly

Mundipharma Pharmaceuticals Limited - Formerly Napp Laboratories

mundi_logo

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 Levact 25mg and 100 mg powder for concentrate for solution for infusion Active Ingredients Bendamustine Hydrochloride
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
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….’

 

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 - date of revision

Updated on 15 March 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 28 February 2017 PIL

Reasons for updating

  • New PIL for new product