Briviact film-coated tablets

  • Name:

    Briviact film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Brivaracetam

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/08/18

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Summary of Product Characteristics last updated on medicines.ie: 24/7/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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UCB (Pharma) Ireland Limited

UCB (Pharma) Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Briviact 10 mg/ml solution for injection/infusion Active Ingredients Brivaracetam
Medicine Name Briviact 10mg/ml oral solution Active Ingredients Brivaracetam
Medicine Name Briviact film-coated tablets Active Ingredients Brivaracetam
Medicine Name Cimzia 200 mg solution for injection in pre-filled pen Active Ingredients Certolizumab Pegol
Medicine Name Cimzia 200 mg solution for injection in pre-filled syringe Active Ingredients Certolizumab Pegol
Medicine Name Keppra 100 mg/ml oral solution Active Ingredients Levetiracetam
Medicine Name Keppra 1000 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 100mg/ml concentrate for solution for infusion Active Ingredients Levetiracetam
Medicine Name Keppra 250 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 500 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 750 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Neupro 1mg/24hr and 3 mg/24 hTransdermal Patch Active Ingredients Rotigotine
Medicine Name Neupro 2mg/24hr Transdermal Patch Active Ingredients Rotigotine
Medicine Name Neupro 4 mg/24hr, 6 mg/24hr, 8 mg/24hr Transdermal Patch Active Ingredients Rotigotine
Medicine Name Tylex 30mg/500mg Hard Capsules Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Vimpat 10 mg/ml solution for infusion Active Ingredients lacosamide
Medicine Name Vimpat 10 mg/ml syrup Active Ingredients lacosamide
Medicine Name Vimpat 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets Active Ingredients lacosamide
Medicine Name Xyrem 500mg/ml oral solution Active Ingredients Sodium oxybate
Medicine Name Xyzal 0.5mg/ml oral solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg Tablets Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg/ml Oral Drops, Solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Zirtek Allergy Relief 10 mg film-coated tablets (OTC) Active Ingredients Cetirizine Dihydrochloride
Medicine Name Zirtek Oral Solution Active Ingredients Cetirizine Dihydrochloride
Medicine Name Zirtek Plus Decongestant 5mg/120mg Prolonged Release Tablets Active Ingredients Cetirizine Dihydrochloride, Pseudoephedrine Hydrochloride
1 - 0 of 26 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 24 July 2019 SmPC

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

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

Updated on 1 August 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • 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 6 - date of revision

Updated on 1 August 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 5.2 - Pharmacokinetic 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

Changes concerning the approval of Briviact in paediatric patients (>=4 years old)

 Sections:

 4.1. Therapeutic indications;4.4 Special warnings and precautions for use;4.8 Undesirable effects;5.1 Pharmacodynamic properties;5.2 Pharmacokinetic properties;10 Date of revision of the text

Updated on 18 July 2018 PIL

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 18 July 2018 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

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

Free text change information supplied by the pharmaceutical company

paediatric indication update to section 4.1, 4.2, 4.8, 5.1, 5.2

Updated on 26 April 2017 SmPC

Reasons for updating

  • 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 5.2 - Pharmacokinetic 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

4.5       Interaction with other medicinal products and other forms of interaction
Editorial change

​​

4.8      Undesirable effects

​​

Type I hypersensitivity (Immune system disorders -Uncommon)

​​

Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.

​​

5.2      Pharmacokinetic properties

​​

Biotransformation

​​

[…] Both metabolites, are further metabolised forming a common hydroxylated acid formed predominantly by hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9). […]

Updated on 26 April 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 24 April 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 24 April 2017 PIL

Reasons for updating

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

Updated on 27 March 2017 SmPC

Reasons for updating

  • Previous version of SPC reinstated

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

Free text change information supplied by the pharmaceutical company

Previous version of SPC reinstated

Updated on 23 March 2017 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 28 February 2017 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic 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

In section 4.8 (undesirable effects), Type I hypersensitivity has been added with uncommon frequency

And the description of the above mentioned adverse reaction has been added as follow “Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of brivaracetam patients (9/3022) during clinical development.”

In section 5.2 (Biotransformation): “[…] Both metabolites, are further metabolised forming a common hydroxylated acid formed predominantly by hydroxylation of the propyl side chain on the carboxylic acid metabolite (mainly by CYP2C9).”

Updated on 27 February 2017 PIL

Reasons for updating

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

Updated on 22 December 2016 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

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 (how to report undesirable effects), has been updated the reporting system for Ireland

Updated on 19 December 2016 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • 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

Shlef life was changed from 3 years to 4 years

Updated on 16 December 2016 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 24 June 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 24 June 2016 PIL

Reasons for updating

  • New PIL for new product