Lixiana Film-Coated Tablets

  • Name:

    Lixiana Film-Coated Tablets

  • Company:
    info
  • Active Ingredients:

    Edoxaban tosilate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/11/20

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Summary of Product Characteristics last updated on medicines.ie: 17/11/2020
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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Daiichi Sankyo Ireland Ltd

Daiichi Sankyo Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name BENETOR 10mg, 20 mg and 40 mg film-coated tablets Active Ingredients olmesartan medoxomil
Medicine Name BENETOR PLUS 20mg/12.5mg and 20mg/25mg film-coated tablets Active Ingredients Hydrochlorothiazide, olmesartan medoxomil
Medicine Name Efient 5mg & 10mg film-coated tablets (Eli Lilly and Company Ltd Daiichi Sankyo UK Ltd) Active Ingredients prasugrel hydrochloride
Medicine Name Evista Active Ingredients Raloxifene
Medicine Name Lixiana Film-Coated Tablets Active Ingredients Edoxaban tosilate
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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 17 November 2020 Ed-Ptnt

Reasons for updating

  • Replace document

Free text change information supplied by the pharmaceutical company

Removal of Black Triangle

Updated on 17 November 2020

Reasons for updating

  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Removal of Black Triangle dated: 29/10/2020

Updated on 17 November 2020 PIL

Reasons for updating

  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Removal of Black Triangle approved:29/10/2020

Updated on 10 July 2020

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data

Free text change information supplied by the pharmaceutical company

Update following approval variation PAM E314

Updated on 8 April 2020 PIL

Reasons for updating

  • New PIL for new product

Free text change information supplied by the pharmaceutical company

Updated during Renewal porcedure.

Update to sections:

  • 1. What Lixiana is and what it is used for
  • 2. Do not take Lixiana
  • 2. Warning s and precautions
  • 2. Other medicines and Lixiana 
  • 4. Possible Side Effects
  • 6. Contents of the pack and other information
  • other sources of information

Updated on 8 April 2020 Ed-Ptnt

Reasons for updating

  • Add New Doc

Free text change information supplied by the pharmaceutical company

Updated following approval of renewal procedure.

Update to sections:

  • Treatment information
  • Information for Healthcare Professionals
  • About your treatment

Updated on 8 April 2020

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Free text change information supplied by the pharmaceutical company

SmPC updated following Renewal procedure including several text revisions, including the QRD 10.1 update and further stylistic and content changes

Updated on 2 July 2019

Reasons for updating

  • New SmPC for new product