BuTrans 15 microgram/hour transdermal patches

  • Name:

    BuTrans 15 microgram/hour transdermal patches

  • Company:
    info
  • Active Ingredients:

    Buprenorphine

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/02/19

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 11/2/2019

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 11 February 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents

Updated on 11 February 2019 SmPC

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)

Free text change information supplied by the pharmaceutical company

Addition of details of child resistant packaging

Updated on 2 February 2017 SmPC

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

Section 4.5

The following has been replaced with (added text in red)

Benzodiazepines: This combination can potentiate respiratory depression of central origin, with risk of death in case of overdose (see section 4.4).


Benzodiazepines: This combination can potentiate respiratory depression of central origin(see section 4.4).

Section 4.6

The following has been changed (text in red has been added)

Prolonged use Long term administration  of buprenorphine during the last three months of pregnancy can result in neonatal opioid may cause a withdrawal syndrome. in the neonate.

Section 4.8

 (Psychiartic disorders) Affect lability has been changed from liability. Libido decreased has been changed from Decreased Libido.

(Nervous system disorders)  Seizures has been added. Abnormal co-ordination has been changed to Co-ordination abnormal.

Renal and urinary disorders - Urinary incontinence has been added.  Urinary hesitation has been added. Micturtion disorder has been removed.

General disorders and administration site conditions - Drug withdrawal syndrome neonatal has been added.

Updated on 2 February 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 26 January 2017 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 4 - possible side effects

Updated on 26 January 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 May 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 18 April 2016 PIL

Reasons for updating

  • New PIL for new product