Inovelon Tablets

  • Name:

    Inovelon Tablets

  • Company:
    info
  • Active Ingredients:

    Rufinamide

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/07/20

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Summary of Product Characteristics last updated on medicines.ie: 15/7/2020

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Eisai Ltd

Eisai Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Fycompa 0.5 mg/ml oral suspension Active Ingredients Perampanel
Medicine Name Fycompa tablets Active Ingredients Perampanel
Medicine Name Gliadel Active Ingredients Carmustine
Medicine Name Halaven 0.44 mg/ml solution for injection Active Ingredients Eribulin mesylate
Medicine Name Inovelon Oral Suspension Active Ingredients Rufinamide
Medicine Name Inovelon Tablets Active Ingredients Rufinamide
Medicine Name Lenvima (lenvatinib) Active Ingredients Lenvatinib mesilate
Medicine Name Targretin Capsules Active Ingredients Bexarotene
Medicine Name Zebinix 200mg tablets Active Ingredients eslicarbazepine acetate
Medicine Name Zebinix 50 mg/ml Oral Suspension Active Ingredients eslicarbazepine acetate
Medicine Name Zebinix 800mg tablets Active Ingredients eslicarbazepine acetate
Medicine Name Zonegran 100 mg hard capsules Active Ingredients Zonisamide
Medicine Name Zonegran 25 mg hard capsules Active Ingredients Zonisamide
Medicine Name Zonegran 50 mg hard capsules Active Ingredients Zonisamide
1 - 0 of 14 items.Total: Infinity pages

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 15 July 2020

Reasons for updating

  • Improved presentation of SmPC

Free text change information supplied by the pharmaceutical company

Minor formatting changes

Updated on 15 July 2020 PIL

Reasons for updating

  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Minor formatting changes

Updated on 2 July 2020

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

SPC Section affected

Change

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

 

 

Section 10 Date of Revision of the Text

Amended to 26 May 2020

Updated on 2 July 2020 PIL

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 PIL

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

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

Free text change information supplied by the pharmaceutical company

SmPC Section

Changes

4.1          Therapeutic indications

The acronym (LGS) has been added after Lennox Gastaut syndrome.

 

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

 

 

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.”

 

4.5          Interaction with other medicinal products and other forms of interaction

Several mentions of ‘b.i.d.’ amended to ‘twice daily’

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””

10.          DATE OF REVISION OF THE TEXT

 

 

Updated to 07/2019

 

 

Updated on 22 January 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer

Updated on 18 January 2019

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Updated on 18 January 2019 PIL

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 PIL

Reasons for updating

  • XPIL Created

Updated on 13 August 2018 PIL

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

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

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 4 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 December 2017 PIL

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 SPC

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

Removal of Inovelon Oral suspension.

Documented changes

Sections of the SPC

Changes/updates

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.”

 

Section 4.6 Fertility, pregnancy and lactation

 

 

Change of wording including the addition of the sentence: “AED treatment during pregnancy should be carefully discussed with the treating physician.”

 

Section 4.8 Undesirable effects

 

 

Additional information on special populations:

Paediatric Population (age 1 to less than 4 years).

 

Section 5.1 Pharmacodynamic properties

 

 

Addition of new information in subsection Clinical experience.

 

Section 5.2 Pharmacokinetic properties

 

Subheading “Older people” moved and changed to “Elderly”

 

The following statement has changed from: “Studies in new-born infants or infants and toddlers under 2 year of age have not been conducted.” to “Studies in new-born infants or infants and toddlers under 1 year of age have not been conducted.”

 

 

 

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.”

 

Section 7. Marketing Authorisation Holder 

“European Knowledge Centre” was added to the address details.

 

Section 9. Date Of First Authorisation/Renewal Of The Authorisation

 

 

Date of latest renewal, changed from 16 of January 2012 to 09 of January 2012.

Section 10 Date of Revision of the text

 

The date of revision has been updated to January 2017.

 


Updated on 25 January 2017

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 24 January 2017 PIL

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 SPC

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

Addition of details for reporting AEs

Updated on 2 August 2013 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 24 July 2013 SPC

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

"Elderly" has been changed to "older people" throughout the SPC
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 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 12 December 2012 SPC

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 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 23 May 2012 SPC

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

Addition of Oral Suspension Information

Updated on 24 January 2012 SPC

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 5 December 2011 SPC

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 4.5 - removal of itneractions with carbamazepine, phenobarbital, phenytoin, vigabatrin, primidone
Section 9 - change to date of revision of text

Updated on 2 December 2011 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 29 March 2011 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 15 December 2009 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 15 December 2009 SPC

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

Section 6.3:
Shelf life updated from 3 years to 4 years

Date of revision of text updated to: 23rd October 2009

Updated on 2 September 2009 PIL

Reasons for updating

  • Change to further information section

Updated on 30 March 2009 SPC

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

Section 7: Change to MA holder address
 
Section 10: Date of revision of text updated to 10th March 2009

Updated on 27 March 2009 PIL

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 9 July 2008 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 8 July 2008 SPC

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 SPC

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

 Section 4.4 - Special warnings and precautions for use

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 PIL

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 31 January 2008 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 November 2007 SPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)