Multaq 400mg Film-coated Tablets
*Company:
SANOFIStatus:
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
Ireland Multaq RMM - Prescriber Guide - January 2023 (1) (1).pdf
Reasons for updating
- Replace File
File name
Ireland Multaq RMM - Prescriber Guide - January 2023 (1).pdf
Reasons for updating
- Replace File
File name
Ireland Multaq RMM - Prescriber Guide - January 2023.pdf
Reasons for updating
- Replace File
Updated on 13 December 2022
File name
1.3.2.1 Mock-up - Package Leaflet (PIL)- Multaq (2).pdf
Reasons for updating
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
- Change to section 6 - manufacturer
Updated on 01 December 2022
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Multaq (4).pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 07 April 2022
File name
1.3.2.1 Mock-up - Package Leaflet (PIL)- Multaq (1).pdf
Reasons for updating
- Improved presentation of PIL
Updated on 07 April 2022
File name
1.3.1.1 Summary of Product Characteristics (SmPC) Multaq.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 05 January 2022
File name
1.3.2.1 Mock-up - Package Leaflet (PIL)- Multaq.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 17 December 2021
File name
SPC.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 17 December 2021
File name
185968 (1).pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - what the product contains
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - marketing authorisation holder
File name
Multaq+prescriber+guide - MAT-IE-2001044 - Final.pdf
Reasons for updating
- Add New Doc
Updated on 01 February 2021
File name
1.3.2.1 Mock-up - Package Leaflet (PIL)- Multaq (IE & MT).pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 03 August 2020
File name
1.3.2 IE Mock-up PIL - 779782 - PSUSA201907 [SA2027].pdf
Reasons for updating
- XPIL Removed
Updated on 03 August 2020
File name
1.3.2 IE Mock-up PIL - 779782 - PSUSA201907 [SA2027].pdf
Reasons for updating
- XPIL Removed
Updated on 11 June 2020
File name
1.3.1 SPC IE PSUSA201907 [SA2027].pdf
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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 4.5 and 10 of the SPC to add the drug interaction with rivaroxaban:
Interaction with medicinal products metabolised by CYP 3A4 and P-gp
Rivaroxaban
Dronedarone is likely to increase the exposure of rivaroxaban (a CYP3A4 and P-gp substrate) and consequently concomitant use may increase the risk of bleedings. Concomitant use of rivaroxaban and dronedarone is not recommended.
Apixaban
Dronedarone may increase the exposure of apixaban (a CYP3A4 and P-gp substrate). However, no dose adjustment for apixaban is required when co-administered with agents that are not strong inhibitors of both CYP3A4 and P-gp, such as dronedarone.
Edoxaban
In in vivo studies edoxaban (a CYP3A4 and P-gp substrate) exposure was increased when administered with dronedarone. The edoxaban dose should be reduced according to the edoxaban label recommendations.
Updated on 11 June 2020
File name
1.3.2 IE Mock-up PIL - 779782 - PSUSA201907 [SA2027].pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 09 December 2019
File name
Multaq PIL.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 3 - dose and frequency
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation number
Updated on 26 September 2019
File name
SPC IE.pdf
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 25 September 2019
File name
PIL.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 25 September 2019
File name
1.3.2 Mock-up PIL-[001][003] 745447 Ireland CP split - SA1028.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 28 March 2018
File name
PIL_14597_870.pdf
Reasons for updating
- New PIL for new product
Updated on 28 March 2018
Reasons for updating
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 22 December 2014
Reasons for updating
- Change to, or new use for medicine
- Change to warnings or special precautions for use
- Change of contraindications
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to information about driving or using machinery
- Change to date of revision
Updated on 03 October 2014
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 03 October 2014
Reasons for updating
- 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 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 10 December 2013
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 10 September 2013
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 11 June 2013
Reasons for updating
- Change to side-effects
Updated on 05 February 2013
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 03 December 2012
Reasons for updating
- 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.5 has been updated following safety signals to include an update on the above and also the concommitant use of dronedarone and statins, and to update tht text regarding immunosuppresants.
Updated on 23 November 2012
Reasons for updating
- 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 4.8 - 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 29 August 2012
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 24 August 2012
Reasons for updating
- Improved electronic presentation
Updated on 24 October 2011
Reasons for updating
- 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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
All listed sections have been modified to include restrictions on use, contraindications and warnings
Updated on 16 February 2011
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 08 February 2011
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 4.5 - 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 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 03 March 2010
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 02 March 2010
Reasons for updating
- New PIL for new product