Updated on 18 December 2023
File name
1.3.2 Mock-up PIL - Rilutek IE & UK(NI).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 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 08 December 2023
File name
1.3.1.1 SmPC - Rilutek IE & UK(NI).pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 31 July 2023
File name
1.3.2 Mock-up PIL IENI.pdf
Reasons for updating
- Improved presentation of PIL
Updated on 31 January 2023
File name
1.3.1 SPC IENI - clean.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 not be renewed (A)
Updated on 31 January 2023
File name
1.3.1 IE_NI PIL Rilutek - clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 18 January 2022
File name
1.3.1 IE_NI PIL Rilutek.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
- Change to section 6 - date of revision
Updated on 20 November 2020
File name
1.3.1 SPC IE.pdf
Reasons for updating
- 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 not be renewed (A)
Updated on 20 November 2020
File name
1.3.2 Mock-up PIL IE.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 - use in children and adolescents
- 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 2 - excipient warnings
- 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
- Change to section 6 - date of revision
Updated on 06 July 2020
File name
Rilutek PIL.pdf
Reasons for updating
- XPIL Removed
Updated on 16 October 2019
File name
Rilutek SPC.pdf
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)
Updated on 08 October 2019
File name
Rilutek PIL.pdf
Reasons for updating
- New PIL for medicines.ie
Updated on 18 June 2019
File name
1.3.1 SPC IE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
For variation:
MAH transfer to:
Sanofi Mature IP
54 Rue de la Boétie
75008 Paris
France
Updated on 18 June 2019
File name
1.3.1 SPC IE.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
MAH transfer to:
Sanofi Mature IP
54 Rue de la Boétie
75008 Paris
France
Updated on 11 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 11 December 2017
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
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie
Updated on 19 February 2015
File name
PIL_9684_837.pdf
Reasons for updating
- New PIL for new product
Updated on 19 February 2015
Reasons for updating
- Change to further information section
Updated on 06 January 2014
Reasons for updating
- Change to section 3 - Pharmaceutical form
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- 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 6.5 - Nature and contents of container
- Change to section 2 - Qualitative and quantitative composition
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 15 January 2013
Reasons for updating
- Change of distributor details
Updated on 23 February 2011
Reasons for updating
- Change to name of manufacturer
Updated on 14 July 2009
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them were severe (see section 4.8). If respiratory symptoms develop such as dry cough and/or dyspnea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately. In the majority of the reported cases, symptoms resolved after drug discontinuation and symptomatic treatment."
Section 4.8 addition of: "Respiratory, thoracic and mediastinal disorders, Uncommon: interstitial lung disease (see section 4.4)"
Updated on 08 July 2009
Reasons for updating
- Change to warnings or special precautions for use
Updated on 24 June 2009
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 27 June 2008
Reasons for updating
- Change due to user-testing of patient information
Updated on 02 May 2008
Reasons for updating
- 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
Updated on 19 December 2006
Reasons for updating
- Improved electronic presentation
Updated on 19 October 2006
Reasons for updating
- Improved electronic presentation
Updated on 28 August 2006
Reasons for updating
- 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 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 4.2: Information on use in children updated.
Section 4.3: breast-feeding replaces the word lactating
Section 4.4: Information on use in children deleted
Section 4.6: breast-feeding replaces the word lactating
Section 4.7: The sentence 'No studies on the effects on the ability to drive and use machines have been performed'.
Section 4.8: All section 4.8 has been updated and previous text deleted. The frequency of the occurrence of adverse events are now documented.
Updated on 21 March 2006
Reasons for updating
- Improved electronic presentation
Updated on 18 May 2005
Reasons for updating
- New PIL for medicines.ie
Updated on 17 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)