Zebinix 200mg tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Eslicarbazepine acetate

Boleh didapati daripada:

Eisai Ltd

Kod ATC:

N03AF04

INN (Nama Antarabangsa):

Eslicarbazepine acetate

Dos:

200mg

Borang farmaseutikal:

Tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF:

Risalah maklumat

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZEBINIX 200 MG TABLETS
Eslicarbazepine acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zebinix is and what it is used for
2.
What you need to know before you take Zebinix
3.
How to take Zebinix
4.
Possible side effects
5.
How to store Zebinix
6.
Contents of the pack and other information
1.
WHAT ZEBINIX IS AND WHAT IT IS USED FOR
Zebinix contains the active substance eslicarbazepine acetate.
Zebinix belongs to a group of medicines called antiepileptics used to
treat epilepsy, a condition where
someone has repeated seizures or fits.
Zebinix is used:

on its own (monotherapy) in adult patients with newly diagnosed
epilepsy

with other antiepileptic medicines (adjunctive therapy), in adult,
adolescents and children
patients above 6 years of age who are experiencing seizures that
affect one part of the brain
(partial seizure). These seizures may or may not be followed by a
seizure affecting all of the
brain (secondary generalisation)
Zebinix has been given to you by your doctor to reduce your number of
seizures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZEBINIX
DO NOT TAKE ZEBINIX:

if you are allergic to eslicarbazepine acetate, to other carboxamide
derivatives (e.g.
carbamazepine or oxcarbazepine, medicines used to treat epilepsy) or
to any of the other
ingredients of this medicine (listed in section 6);

if you suffer from a certain type of heart rhythm disorder (second or
third degree
atrioventricular (AV) block).
WARNING

Ciri produk

OBJECT 1
ZEBINIX 200MG TABLETS
Summary of Product Characteristics Updated 05-Jul-2018 | Eisai Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Zebinix 200 mg tablets
Zebinix 800 mg tablets
2. Qualitative and quantitative composition
Zebinix 200 mg tablets
Each tablet contains 200 mg of eslicarbazepine acetate.
Zebinix 800 mg tablets
Each tablet contains 800 mg of eslicarbazepine acetate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Zebinix 200 mg tablets
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.
Zebinix 800 mg tablets
White oblong tablets, engraved 'ESL 800'on one side and scored on the
other side, with a length of 19
mm. The tablet can be divided into equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Zebinix is indicated as:
• monotherapy in the treatment of partial-onset seizures, with or
without secondary generali