Zebinix 50 mg/ml Oral Suspension

  • Name:

    Zebinix 50 mg/ml Oral Suspension

  • 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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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 section 6 - date of revision
  • 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.”

Revision date has been amended to 03/2019

Updated on 11 December 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 11 December 2018 SmPC

Reasons for updating

  • New SmPC for new product

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