« Back to Medicines list

Abstral Sublingual Tablets

  • Name:

    Abstral Sublingual Tablets

  • Company:
    info
  • Active Ingredients:

    fentanyl citrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/12/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 12/1/2021

Click on this link to Download PDF directly

Kyowa Kirin International plc

KyowaKirin_BrandLogo_color_1604596269

Company Products

Medicine NameActive Ingredients
Medicine Name Abstral Sublingual Tablets Active Ingredients fentanyl citrate
Medicine Name Chlorphenamine 10mg/ml solution for injection Active Ingredients Chlorphenamine Maleate
Medicine Name Crysvita solution for subcutaneous injection Active Ingredients Burosumab
Medicine Name Moventig 12.5 mg and 25 mg film-coated tablets Active Ingredients Naloxegol oxalate
Medicine Name Pabrinex Intravenous High Potency, Concentrate for Solution for Infusion Active Ingredients Ascorbic acid, Glucose Monohydrate, Nicotinamide, Pyridoxine Hydrochloride (Vitamin B6), Riboflavin sodium phosphate (Vitamin B2), Thiamine Hydrochloride (Vitamin B1)
Medicine Name POTELIGEO 4 mg/mL concentrate for solution for infusion Active Ingredients Mogamulizumab
Medicine Name Rectogesic 4 mg/g Rectal Ointment Active Ingredients Glyceryl Trinitrate
Medicine Name Thiopental Sodium 500 mg Powder for Solution for Injection Active Ingredients Thiopental Sodium
Medicine Name Tostran 2% Gel Active Ingredients Testosterone
Medicine Name Xomolix 2.5mg/ml solution for injection Active Ingredients Droperidol
1 - 0 of 10 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 12 January 2021 SPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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 Special warnings and precautions for use

Following wording added:

Abstral contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Section 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Changed From:

Date of first authorisation: 2008-02-29

Date of latest renewal: 2013-02-28

To:

 Date of first authorisation: 19/09/2008
Date of latest renewal: 28/02/2013

 

Section 10. DATE OF REVISION OF THE TEXT

Changed From:

May 2019

To:

11 January 2021

Updated on 10 December 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 13 August 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 17 February 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 4 November 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 29 August 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 29 August 2019 SPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

In section 4.8. The term "delirium" has been added.

​

In section 10 the date of revision of the text has been updated to August 2019.

Updated on 1 May 2019 PIL

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 1 May 2019 SPC

Reasons for updating

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

In section 4.8 the following has been added to the column "Not known":

Depressed level of consciousness

 Loss of consciousness

Urticaria

In section 4.9 the following sateen has been added:

Coma is also known to occur.

 

In section 10, the date of revision of the text has been updated to March 2019.

Updated on 16 October 2018 Ed-Ptnt

Reasons for updating

  • Add New Doc

Updated on 16 October 2018 Ed-HCP

Reasons for updating

  • Add New Doc

Updated on 3 September 2018 PIL

Reasons for updating

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

Updated on 3 September 2018 SPC

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 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)

Updated on 4 April 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 4 April 2018 SPC

Reasons for updating

  • 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

In section 5.5 the addiction of text regarding CYP3A4 inducers.
In section 10 the date of revision of the text

Updated on 28 March 2018 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 28 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 18 July 2016 SPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 7 - Marketing authorisation holder
  • 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 6.3  - Shelf life has been changed from 3 years to 2 years.
Section 7 - MAH has changed from PoStrakan to Kyowa Kirin.
Section 10 - Date of revision of the text to May 2016.

Updated on 18 July 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 18 July 2016 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 18 February 2016 SPC

Reasons for updating

  • New SPC for medicines.ie

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 December 2015 PIL

Reasons for updating

  • New PIL for medicines.ie