Inovelon Tablets
*Company:
Eisai LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may not be renewed (A)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 14 December 2023
File name
ROI Inovelon Tablets PIL Nov 2023.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - what the product contains
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 14 December 2023
File name
ROI Inovelon Tablets SmPC Nov 2023.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 March 2023
File name
ROI Inovelon tabs PIL Feb 2023.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 January 2023
File name
ROI Inovelon tabs SmPC_Mar 2021.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 July 2021
File name
Inovelon tablets PIL_ROI July 2021.pdf
Reasons for updating
- Change to other sources of information section
Free text change information supplied by the pharmaceutical company
5. How to store Inovelon
Updated on 30 March 2021
File name
ROI Inovelon tabs PIL_Mar 2021.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 15 July 2020
File name
ROI Inovelon tablets SmPC_26 05 2020.pdf
Reasons for updating
- Improved presentation of SPC
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Minor formatting changes
Updated on 15 July 2020
File name
ROI Inovelon tablets PIL_05 2020.pdf
Reasons for updating
- Improved presentation of PIL
Free text change information supplied by the pharmaceutical company
Minor formatting changes
Updated on 02 July 2020
File name
Inovelon tablets ROI SmPC clean 00112020.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- 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
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SPC Section affected |
Change |
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Section 7 Marketing Authorisation Holder |
Change of MAH address details:
From :
Eisai GmbH Lyoner Straße 36 60528 Frankfurt am Main Germany
Amended to:
Eisai GmbH Edmund-Rumpler-Straße 3 60549 Frankfurt am Main Germany
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Section 10 Date of Revision of the Text |
Amended to 26 May 2020 |
Updated on 02 July 2020
File name
Inovelon tablets ROI PIL clean 00112020.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 16 August 2019
File name
ROI Inovelon tablets PIL_07 2019.pdf
Reasons for updating
- Change to section 6 - date of revision
- Correction of spelling/typing errors
- Change to improve clarity and readability
Updated on 15 August 2019
File name
ROI Inovelon tablets SmPC_07 2019.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- 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 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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SmPC Section |
Changes |
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4.1 Therapeutic indications |
The acronym (LGS) has been added after Lennox Gastaut syndrome.
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4.2 Posology and method of administration |
Under Posology The following headings have been amended in this section:
Use in children from 1 year to less than 4 years of age (numerals 1 and 4 replace the words ‘one’ and ‘four’ respectively)
Use in children 4 years of age or older and less than 30 kg (numeral 4 replaces the word ‘four’)
Use in adults, adolescents and children 4 years of age or older of 30 kg or over (numeral 4 replaces the word ‘four’)
‘ml’ replaces ‘mL’ throughout Use in children from 1 year to less than 4 years of age
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4.4 Special warnings and precautions for use |
Under Hypersensitivity reactions The acronym (AED) has been added after ‘antiepileptic drug’
The word ‘As’ has replaced ‘Because’ in the following sentence: “As the disorder is variable in its expression, other organ system signs and symptoms not noted here may occur.”
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4.5 Interaction with other medicinal products and other forms of interaction |
Several mentions of ‘b.i.d.’ amended to ‘twice daily’ |
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5.1 Pharmacodynamic properties |
Under Clinical experience The word ‘As’ has replaced ‘Because’ in the following sentence: “As it is difficult for caregivers to precisely separate tonic and atonic seizures, the international expert panel of child neurologists agreed to group these seizure types and call them tonic–atonic seizures or “drop attacks”” |
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10. DATE OF REVISION OF THE TEXT
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Updated to 07/2019 |
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Updated on 22 January 2019
File name
ROI PIL tablets_Nov2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
Updated on 18 January 2019
File name
ROI Inovelon SmPC Tablets November 2018.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 January 2019
File name
ROI PIL tablets_Nov2018.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 12 September 2018
File name
ROI PIL tablets_Aug2018.pdf
Reasons for updating
- XPIL Created
Updated on 13 August 2018
File name
ROI PIL tablets_Aug2018.pdf
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 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 6 - date of revision
Updated on 13 August 2018
File name
ROI Inovelon SmPC Tablets August 2018.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- 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 6.6 - Special precautions for disposal and other handling
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Extension of indication to include the treatment of seizures associated with Lennox Gastaut syndrome in patients 1 year of age and older as adjunctive therapy. As a consequence sections 4.1, 4.2, 4.5, 5.1 and 5.2 are updated accordingly.
Updated on 04 December 2017
File name
PIL_12666_296.pdf
Reasons for updating
- New PIL for new product
Updated on 04 December 2017
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
- Improved presentation of PIL
Updated on 25 January 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 25 January 2017
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 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Change to section 10 - Date of revision of the text
- Correction of spelling/typing errors
- Change from joint to individual SPCs
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
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Documented changes |
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Sections of the SPC |
Changes/updates |
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Section 4.2 Posology and method of administration |
Change of subheading from “Older people”. To “Elderly”
Under the subheading ‘paediatric population’, removal of: “No data are available.” Addition of new information: “Currently available data are described in section 4.8 and 5.1 but no recommendation on a posology can be made.”
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Section 4.6 Fertility, pregnancy and lactation
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Change of wording including the addition of the sentence: “AED treatment during pregnancy should be carefully discussed with the treating physician.”
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Section 4.8 Undesirable effects
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Additional information on special populations: Paediatric Population (age 1 to less than 4 years).
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Section 5.1 Pharmacodynamic properties
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Addition of new information in subsection Clinical experience.
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Section 5.2 Pharmacokinetic properties
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Subheading “Older people” moved and changed to “Elderly”
The following statement has changed from: “Studies in new-born infants
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Section 5.3 Preclinical safety data |
Addition of new information: “The toxicity profile of rufinamide in juvenile animals was similar to that in adult animals. Decreased body weight gain was observed in both juvenile and adult rats and dogs. Mild toxicity in the liver was observed in juvenile as well as in adult animals at exposure levels lower than or similar to those reached in patients. Reversibility of all findings was demonstrated after stopping treatment.”
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Section 7. Marketing Authorisation Holder |
“European Knowledge Centre” was added to the address details.
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Section 9. Date Of First Authorisation/Renewal Of The Authorisation
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Date of latest renewal, changed from 16 of January 2012 to 09 of January 2012. |
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Section 10 Date of Revision of the text
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The date of revision has been updated to January 2017.
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Updated on 24 January 2017
Reasons for updating
- 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 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Correction of spelling/typing errors
Updated on 17 September 2013
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
Updated on 02 August 2013
Reasons for updating
- Addition of information on reporting a side effect.
Updated on 24 July 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.3 - Shelf life
- Change to section 9 - Date of renewal of authorisation
- 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
Section 6.3:
Shelf life for suspension has changed from 2 to 3 years
Section 9:
Date of latest renewal is now 16 January 2012
Section 10:
Date of revision of text is 29 June 2013
Updated on 24 July 2013
Reasons for updating
- Change to MA holder contact details
Updated on 12 December 2012
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
- 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
DRESS & SJS have been added to the hypersensitivity reactions in Section 4.4
Clarification that there is no rufinamide-phenytoin interaction added in Section 4.5.
Updated on 10 December 2012
Reasons for updating
- Change to MA holder contact details
Updated on 23 May 2012
Reasons for updating
- Change to section 3 - Pharmaceutical form
- Change to section 4.2 - Posology and method of administration
- Change to section 6.1 - List of excipients
- Change to section 6.3 - Shelf life
- Change to section 6.4 - Special precautions for storage
- Change to section 6.5 - Nature and contents of container
- 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 24 January 2012
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 9 - Date of renewal of authorisation
- 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
Addition of the following text to section 4.4:
Suicidal ideation
Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications. A meta-analysis of randomised placebo-controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Inovelon.
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge.
Updated date in sections 9 and 10
Updated on 20 January 2012
Reasons for updating
- Change to side-effects
- Change to drug interactions
Updated on 05 December 2011
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 9 - Date of renewal of authorisation
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Section 9 - change to date of revision of text
Updated on 02 December 2011
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 29 March 2011
Reasons for updating
- Change to MA holder contact details
Updated on 15 December 2009
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
Shelf life updated from 3 years to 4 years
Date of revision of text updated to: 23rd October 2009
Updated on 15 December 2009
Reasons for updating
- Change to MA holder contact details
Updated on 02 September 2009
Reasons for updating
- Change to further information section
Updated on 30 March 2009
Reasons for updating
- Change to MA holder contact details
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 27 March 2009
Reasons for updating
- Addition of marketing authorisation holder
Updated on 09 July 2008
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 08 July 2008
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
Inovelon SmPC changes – April 2008
4.2 Posology and method of administration
Patients <30 kg also receiving valproate medication:
Change to maximum recommended daily dose of Inovelon in patients <30 kg also receiving valproate medication:
Patients <30 kg also receiving valproate medication:
Treatment should be initiated at a daily dose of 200 mg. According to clinical response and tolerability, after a minimum of 2 days the dose may be increased by 200 mg/day, to the maximum recommended dose of 600 mg/day.
10. DATE OF REVISION OF THE TEXT
The date of revision of text has been updated:
08 April 2008
Updated on 22 February 2008
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- 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
The statement below has been added to this section
In a thorough QT study, rufinamide produced a decrease in QTc interval proportional to concentration. Although the underlying mechanism and safety relevance of this finding is not known, clinicians should use clinical judgment when assessing whether to prescribe rufinamide to patients at risk from further shortening their QTc duration (eg. Congenital Short QT Syndrome or patients with a family history of such a syndrome).
Section 10: Date of revision of the text
This has changed to the 23rd August 2007
Updated on 22 February 2008
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 31 January 2008
Reasons for updating
- New PIL for new product
Updated on 27 November 2007
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)