ZEBINIX eslicarbazepine acetate 800 mg tablet blister pack

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

eslicarbazepine acetate, Quantity: 800 mg

Fáanlegur frá:

Maxx Pharma Pty Ltd

Lyfjaform:

Tablet, uncoated

Samsetning:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; povidone

Stjórnsýsluleið:

Oral

Einingar í pakka:

60 tablets, 30 tablets, 90 tablets, 180 tablets, 20 tablets

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

ZEBINIX is indicated as:,? monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;,? adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.

Vörulýsing:

Visual Identification: ZEBINIX 800 mg tablets are white oblong tablets, engraved with ESL 800 on one side and scored on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

2021-05-18

Upplýsingar fylgiseðill

ZEBINIX® 200 mg and 800 mg tablets
1
ZEBINIX®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
This medicine is new. Please report side effects. See the full CMI for
further details.
1.
WHY AM I USING ZEBINIX?
ZEBINIX contains the active ingredient eslicarbazepine acetate (ESL).
ZEBINIX is used to treat epileptic seizures or fits on its
own, or in combination with other medications. For more information,
see Section 1. Why am I using ZEBINIX? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ZEBINIX?
Do not use if you are allergic to eslicarbazepine acetate, to other
carboxamide derivatives or to any of the ingredients listed in
Section 7. What ZEBINIX contains? in the full CMI. TALK TO YOUR DOCTOR
IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE
BREASTFEEDING. For more information, see Section 2.
What should I know before I use ZEBINIX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ZEBINIX and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ZEBINIX?
•
Use as directed by your doctor. Do not take more than the amount your
doctor tells you to.
•
The tablets should be swallowed with a glass of water.
•
The tablets can be crushed, mixed with water or apple sauce, and all
the dose shall be taken immediately.
•
You can take ZEBINIX with or without food.
More instructions can be found in Section 4. How do I use ZEBINIX? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ZEBINIX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ZEBINIX
•
Call your doctor immediately if you feel very unwell, develop a rash,
blistering, swelling or peeling
on your skin/membranes, swallowing or breathing problems, suffer from
confusion, worsening of
seizures or d

Vara einkenni

▼
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse reactions at
https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – ZEBINIX
(ESLICARBAZEPINE ACETATE) TABLET
1
NAME OF THE MEDICINE
Eslicarbazepine acetate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ZEBINIX 200 mg tablet contains 200 mg of eslicarbazepine acetate.
Each ZEBINIX 800 mg tablet contains 800 mg of eslicarbazepine acetate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablet.
ZEBINIX 200 mg tablets are white oblong tablets, engraved with ‘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 are white oblong tablets, engraved with ‘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
generalisation, in adults with newly diagnosed epilepsy;
•
adjunctive therapy in adults, adolescents and children aged above 6
years, with
partial-onset seizures with or without secondary generalisation.
Page 2 of 22
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
_ADULTS _
_ _
ZEBINIX may be taken as monotherapy or added to existing
anticonvulsant therapy. The
recommended starting dose is 400 mg once daily which should be
increased to 800 mg once
daily after one or two weeks. Based on individual response, the dose
may be increased to
1,200 mg once daily. Some patients on monotherapy regimen may benefit
from a dose of
1,600 mg once daily (see Section 5.1 Pharmacodynamic properties).
_PAEDIATRIC POPULATION _
_ _
_Children above 6 years of age: _
The recommended starting dose is 10 mg/kg/day once daily. Dosage
should be increased in
w