Zebinix 200mg tablets

  • Name:

    Zebinix 200mg tablets

  • Company:
    info
  • Active Ingredients:

    eslicarbazepine acetate

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 08/08/19

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Summary of Product Characteristics last updated on medicines.ie: 7/8/2019

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Eisai Ltd

Eisai Ltd

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1 - 12 of 12 items.Total: 1 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 8 August 2019 PIL

Reasons for updating

  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision
  • Change to instructions about overdose
  • Change to side-effects

Updated on 7 August 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • 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

SmPC Section

Change

Section 4.8 (Undesirable effects),

Under System Organ Class Investigations, added ‘weight increased’ with the frequency 'common'

 

Section 4.9 (Overdose)

Text amended from:

Central nervous symptoms such as vertigo, walking instability and hemi-paresis have been observed with accidental eslicarbazepine acetate overdose. There is no known specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Eslicarbazepine acetate metabolites can effectively be cleared by haemodialysis, if necessary (see section 5.2).

 

to the following (new text in red):

 

Symptoms observed after an overdose of eslicarbazepine acetate are primarily associated with central nervous symptoms (e.g. seizures of all types, status epilepticus) and cardiac disorders (e.g. cardiac arrhythmia). There is no known specific antidote. Symptomatic and supportive treatment should be administered as appropriate. Eslicarbazepine acetate metabolites can effectively be cleared by haemodialysis, if necessary (see section 5.2).

 

Section 10 DATE OF REVISION OF THE TEXT

Amended to 06/2019

 

Updated on 20 May 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to MA holder contact details

Updated on 17 May 2019 SmPC

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

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Summary of Product Characteristics Section 4.2 Posology and method of administration Under the heading Method of administration Switching preparations The text below has been deleted: “Since comparative bioavailability data for the tablet and the suspension formulation are not available, switching patients from one formulation to the other should be done with caution.” Previous text has been replaced with the following: “Based on comparative bioavailability data for the tablet and the suspension formulations, switching patients from one formulation to the other can be done.” Section 4.8 Undesirable effects Addition of following text under Paediatric population heading: Long-term safety data in the paediatric population obtained from open label extensions of the phase III study was consistent with the known safety profile of the product with no new findings of concern. Amendment of the following paragraph under Paediatric population heading: “and hyponatraemia” was added to the following sentence “Dizziness; somnolence; vertigo; asthenia; gait disturbance; tremor; ataxia; balance disorder; vision blurred; diarrhoea; and rash and hyponatraemia were less common in children than in adults. The sentence “Hyponatraemia was only reported in adult population.” was removed. Section 5.1Pharmacodynamic properties The following amendments were made to content under the Paediatric population heading: 1st paragraph: “Study 208 included 2 additional subsequent long-term, open-label extensions (1 year in part II and 2 years in part III) and Study 305 included 4 subsequent long-term, open-label extension periods (1 year in Parts II, III and IV and 2 years in Part V).” 2nd and 3rd paragraph: “In the phase II study” was changed to “double-blind period of the phase II study” The following text was added: “In the subsequent 1-year open-label extension (Part II) of the phase III study (ITT set N=225) the total responder rate was 46.7% (steadily increasing from 44.9% (weeks 1-4) to 57.5% (weeks > 40)). The total median standardised seizure frequency was 6.1 (decreasing from 7.0 (weeks 1-4) to 4.0 (weeks > 40), resulting in a median relative change compared to the baseline period of -46.7%). The median relative change was larger in the previous placebo group (-51.4%) than in the previous ESL group (-40.4%). The proportion of patients with exacerbation (increase of ≥25%) compared to the baseline period was 14.2%. In the subsequent 3 open-label extensions (ITT set N=148), the overall responder rate was 26.6% when compared to baseline Parts III–V (i.e. the last 4 weeks in part II). The total median standardised seizure frequency was 2.4 (resulting in a median relative change from Baseline Part III–V of -22.9%). The overall median relative decrease in Part I was greater in patients treated with ESL (-25.8%) than in patients treated with placebo (-16.4%). The overall proportion of patients with exacerbation (increase of ≥25%) compared to Baseline Parts III–V was 25.7%. Of the 183 patients who completed parts I and II of the study, 152 patients were enrolled into part III. Of these, 65 patients had received ESL and 87 patients had received placebo during the double-blind part of the study. 14 patients (9.2%) completed open-label treatment with ESL through Part V. The most common reason for withdrawal during any part of the study was sponsor request (30 patients in part III [19.7% of the patients who entered part III], 9 in part IV [9.6% of the patients who entered part IV], and 43 in part V [64.2% of the patients who entered Part V]). Taking into consideration the limitations of open label uncontrolled data, the long-term response to eslicarbazepine acetate in the open-label parts of the study was overall maintained.”

Updated on 12 July 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 5 July 2018 SmPC

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)

Updated on 5 July 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 3 July 2018 SmPC

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 be renewed (B)

Updated on 3 July 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 29 August 2017 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • 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

Section 6.5 Nature and contents of container

Pack size added, the text has changed from:

 

Aluminium / Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 20, 30, 60 or 90 tablets.

 

To:

 

Aluminium / Aluminium or PVC/Aluminium blisters placed into cardboard boxes containing 20, 30, 60 or 90 tablets and in multi-packs containing 180 (2 packs of 90) tablets.

 

Section 8 Marketing Authorisation Number

Added marketing authorisation number:

EU/1/09/514/025-026

 

Section 10 Date Of Revision Of The Text    

Revision date: 07/2017

Updated on 29 August 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 25 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 25 August 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 8 May 2017 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Introduction of new strength

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1 Name of Medicinal Product

Addition of 200mg tablet formulation

Section 2 Qual. and Quant. Composition

Addition of 200mg tablet composition: “Each tablet contains 200 mg of eslicarbazepine acetate.”

Section 3 Pharmaceutical Form

Addition of 200mg tablet details:

“White oblong tablets, engraved ’ESL 200’ on one side and scored on the other side, with a length of 11 mm. The tablet can be divided into equal doses.”

Section 4.1 Therapeutic indications

Addition of monotherapy indication details:

 “monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;”

 

Section 4.2 Posology and method of admin

Adults :

The following text was added:

“Zebinix may be taken as monotherapy or added to existing anticonvulsant therapy.”

“Some patients on monotherapy regimen may benefit from a dose of 1,600 mg once daily (see section 5.1).”

Elderly: Addition of the following sentence:

Due to very limited data on the 1,600 mg monotherapy regimen in the elderly, this dose is not recommended for this population.

Section 4.4 Special warnings and precautions for use

Other warnings and precautions:  removed the following sentence: “There is no experience regarding the withdrawal of concomitant use of antiepileptic medicinal products during treatment with Zebinix (i.e. switching to monotherapy)”

Cutaneous reactions: amended percentage value to 1.2% (1.1% previously), minor text change

Hyponatraemia: amended percentage value to 1.5% (1.2% previously)

Section 4.8 Undesirable effects

Summary of the safety profile: Amended to reflect updated patient numbers and ADRs inclusive of monotherapy data:

“In clinical studies (adjunctive therapy treatment and monotherapy), 2,434 patients with partial-onset seizures were treated with eslicarbazepine acetate (1,983 adult patients and 451 paediatric patients) and 51% of those patients experienced adverse reactions.”

 Additional text regarding adjunctive and monotherapy studies:

“The most common adverse reactions reported, in placebo controlled adjunctive therapy studies with adult epileptic patients and in an active controlled monotherapy study comparing eslicarbazepine acetate with carbamazepine controlled release, were dizziness, somnolence, headache, and nausea

Tabulated list of adverse reactions: Additional introductory text inserted regarding ADR table. Amendment to Table heading. Anxiety included in table as uncommon treatment emergent adverse reaction under Psychiatric disorders.

Section 5.1 Pharmacodynamic properties

Mechanism of action: minor text amendment

Change of subheading to Clinical efficacy

Adult population: Addition of monotherapy study data. Addition of data on conversion to monotherapy.

Elderly population: limited data in monotherapy added.

 

 

Section 6.3 Shelf life

Shelf life of 4yrs for 200mg tablet formulation has been added

Section 6.5 Nature and contents of container

Added details for 200mg tablet formulation

Section 8 MARKETING AUTHORISATION NUMBER(S)

Added MA number for 200mg tablet formulation

EU/1/09/514/021-023

Section 10 DATE OF REVISION OF THE TEXT

Amended to April 2017

 

Updated on 5 May 2017 PIL

Reasons for updating

  • New PIL for new product
  • New PIL for medicines.ie

Updated on 22 December 2016 SmPC

Reasons for updating

  • 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 4.4 - 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 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

Sections of the SPC

Changes/updates

3 Pharmaceutical form

 Tablet dimension (length of 19mm) added

4.1       Therapeutic indications

 

 Licensed indication has been amended

From:

 “Zebinix is indicated as adjunctive therapy in adults with    partial-onset seizures with or without secondary generalisation.”

To:  “Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years with partial-onset seizures with or without secondary generalisation.”

4.2       Posology and method of administration

 

- Minor text and formatting changes

- Additional guidance on dosing in renal impairment to include  children above 6 years of age.

- Addition of information regarding dosing in children over 6 years of age, and children with a bodyweight >60kg

- Revised wording regarding safety and efficacy in children aged 6yrs and below has been added.

- Addition of information regarding switching preparations

4.4       Special warnings and precautions for use

 

- Paragraph on oral contraceptives has been removed (included in Section 4.5 Interactions)

- Paragraph regarding concomitant use of oxcarbazepine has been removed (included in Section 4.5 Interactions)

- Removal of text and minor formatting changes to subsection: HLA-B* 1502 allele - in Han Chinese, Thai and other Asian populations.

4.5       Interaction with other medicinal products and other forms of interaction

- Paragraph regarding concomitant use of oxcarbazepine has been added (see Section 4.4 amends above)

- minor text change

4.6       Fertility, pregnancy and lactation

 

- New wording regarding effects on fertility.

- Deleted wording regarding effects on animal fertility. Data now available in section 5.3

4.7       Effects on ability to drive and use machines

- Amended wording on the influence of Zebinix on the ability to drive and use machines.

4.8   Undesirable effects

 

- Amendment of patient numbers to include paediatric patients

- Minor text and formatting amends, including removal of first paragraph under heading Tabulated list of adverse reactions

- The convention for the classification of rare adverse reactions (frequency ≥1/10,000 to <1/1,000) has been removed.

- Table 1 heading has been amended

- The following adverse reactions have been reclassified from rare to unknown frequency: thrombocytopenia, leukopenia, pancreatitis.

- Under Psychiatric disorders, Psychotic disorder has been moved to the top of the column (increased seriousness)

- Under Skin and subcutaneous tissue disorders, dermatitis allergic has been added as an uncommon adverse reaction.

- Paediatric safety data has been added under new heading Paediatric Population

5.1       Pharmacodynamic properties

 

 - Paediatric efficacy data has been added under subheading Paediatric population with removal of previously included text.

- Text formatting and layout changes.

5.2         Pharmacokinetic properties

 

- Minor text amends to Absorption and Biotransformation

- Under Renal impairment, addition of wording relating use in paediatrics, including a warning in children from 2 to 6 years of age.

- A new section Paediatric population has been added

5.3   Preclinical safety data

 

- Additional information relating to juvenile animals studies

- Added information on eslicarbazepine effects on animal fertility (see section 4.6 amends above)

Section 10

 Date of Revision of the Text has been updated to:

 8th December 2016

Updated on 26 June 2015 SmPC

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 be renewed (B)

Free text change information supplied by the pharmaceutical company

The update is to section 4.8 of the SmPC which includes additional information on cutaneous adverse reaction, there has also been a revision of the SPC information on atrioventricular block

Updated on 6 November 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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

New information on use in elderly population has been added under section 4.2 (posology and method of administration) and section 5.1 (pharmacodynamic properties)

Updated on 28 May 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Update of sections 4.4 and 4.8 of the SmPC in order to update the safety information based on the results from a newly completed phase III study (Study BIA-2093-304) in adult patients with refractory partial onset seizures as well as an updated integrated safety analysis of available placebo-controlled clinical trials and other cumulative safety data.

Updated on 17 February 2014 SmPC

Reasons for updating

  • 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 be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 9
Date of latest renewal updated
Section 10
Date of revision updated

Updated on 11 February 2014 SmPC

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 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • 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 renewal of authorisation
  • 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

Section 4.2 Posology & Method of Administration
QRD v5 template
clarification that adolescents are included in the paediatric population.

Section 4.4 Special Warning & Precautions for Use
Introduction of class effect wording for suicidal ideation;
introduction of sub headings through the section.

Section 4.5 Interaction with other medicinal products.
Introduction of examples of drugs.

Section 4.8 Undesirable Effects
Eye & nervous system disorders - information added;
reporting of suspected adverse reactions (QRD v5 template)

Section 5.1 Pharmacodynamic Properties
Clarification added for clinical efficacy & safety;
information on paediatric studies added.

Section 5.2 Pharmacokinetic Properties
Clarification added under the biotransformation sub heading.

Section 5.3 Preclinical Safety
Deletion of information related to Environmental Risk Assessment.

Section 9
Sub header for 'Date of latest renewal'included
Date of latest renewal updated

Section 10
Date of text revision

Updated on 30 April 2013 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Type IB shelf life update (Type IB change B. II f.1.b.1) -section 6.3 of the SmPC was updated

36 months to 60 months for the 400mg strength

48 months to 60 months for 800 mg strength

Updated on 31 January 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 updated: Allele HLA-A*3101 has been shown to increase the risk of developing carbamazepine induced cutaneous adverse reactions including Stevens Johnson syndrome (SJS), TEN, Drug rash with eosinophilia (DRESS) or less severe acute generalised exanthematous pustulosis (AGEP) and maculopapular rash in patients of European descent and Japanese populations.

Updated on 9 October 2012 SmPC

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

On 28 August EMA approved addition of rosuvastatin to the interactions section

Updated on 16 July 2012 SmPC

Reasons for updating

  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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

Section 5.3 updated to contain information that eslicarbazepine acetate posed a risk to the environment. Section 6.6 updated with information on disposal of the product.

Updated on 8 June 2012 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf life has been changed from 3  to 4 years.

Updated on 30 November 2011 SmPC

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Addition of three additional uncommon undesirable effects to section 4.8 – irritability, chest pain, urinary tract infection, Change to section 10 – change to date of revision of text

Updated on 7 March 2011 SmPC

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

None provided