Zebinix 200mg tablets

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

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

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

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