Lixiana Film-Coated Tablets
*Company:
Daiichi Sankyo Ireland LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
File name
lixiana-ie-prescriber-guide-V08-(IE-EDX-10-23-0001)clean_231204.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
updated to add clarithromycin in the table for patients receiving concomitant treatment
Updated on 05 December 2023
File name
lixiana-smpc-ie-v11-231129-(Paediatric update).pdf
Reasons for updating
- 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
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 December 2023
File name
lixiana-pil-ie-v09-231129-(Paediatric update).pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Children and adolescents
Lixiana is not recommended in children and adolescents under 18 years of age.
How to take the tablet
Swallow the tablet, preferably with water.
Lixiana can be taken with or without food.
If you have difficulty swallowing the tablet whole, talk to your doctor about other ways to take Lixiana. The tablet may be crushed and mixed with water or apple puree immediately before you take it. If necessary, your doctor may also give you the crushed Lixiana tablet through a tube via the nose (nasogastric tube) or a tube in the stomach (gastric feeding tube).
Updated on 15 August 2023
File name
lixiana-smpc-ie-v10-230726-(ARN and clarithromycin).pdf
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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 15 August 2023
File name
lixiana-pil-ie-v8-230726-(ARN and clarithromycin).pdf
Reasons for updating
- 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
File name
Lixiana prescriber guide (MDK8814)-V07a-printable version-(tab crushing-PRAC-DUS)-280921.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Printable version
File name
Lixiana prescribing guide -V07-(tab crushing-PRAC DUS)-clean-120521.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Updated following variation addition of tablet crishing and also update following PRAC-DUS
File name
Lixiana Prescriber Guide-V06-(removal blk triangle-renal func NVAF)-010421.pdf
Reasons for updating
- Add New Doc
Free text change information supplied by the pharmaceutical company
Removal of black triangle
updated statement for Special Patient Populations: Renal function in NVAF to exactly reflect the wording as per the relevant SPC section
Updated on 07 December 2020
File name
SmPC-Lixiana-combined-V09-(Tab crushing & bottle)-261120-clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated for advise tablet crushing
Addition of pack size: bottle x 90
Updated on 07 December 2020
File name
Lixiana-PIL-combined-V07-(Tab crushing & bottle)-261120-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
Addition of advise on tablet curshing and addition of pack size: bottle x 90
File name
PAC-Lixiana~V04-(Removal Blk Triangle)-291020.clean.pdf
Reasons for updating
- Replace File
Free text change information supplied by the pharmaceutical company
Removal of Black Triangle
Updated on 17 November 2020
File name
SmPC-Lixiana-combined-V08-(removal blk triangle)-291020-clean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Removal of Black Triangle dated: 29/10/2020
Updated on 17 November 2020
File name
Lixiana-PIL-combined~V06-(Removal Blk Triangle)-291020-clean.pdf
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
File name
SmPC-Lixiana-combined~V07-(PAM E314-)-250620-clean.pdf
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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update following approval variation PAM E314
Updated on 08 April 2020
File name
Lixiana-PIL-combined~V05-(Renewal)-240220-clean.pdf
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
File name
Patient-Alert-Card~V03-(Renewal)-240220-clean.pdf
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 08 April 2020
File name
SmPC-Lixiana-combined~V06-(Renewal)-240220-clean.pdf
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
Legal category:Product subject to medical prescription which may be renewed (B)
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 02 July 2019
File name
SmPC-Lixiana-combined~V05-(IA APS update & combine)-250619-clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)