KEPPRA 250MG FILM COATED TABLET

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Thành phần hoạt chất:

LEVETIRACETAM

Sẵn có từ:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Tên quốc tế):

LEVETIRACETAM

Các đơn vị trong gói:

100 Tablets; 60 Tablets

Sản xuất bởi:

UCB Pharma S.A.

Tờ rơi thông tin

Consumer Medication Information Leaflet (RiMUP)
KEPPRA FILM COATED TABLET / ORAL
SOLUTION
Levetiracetam (250mg, 500mg, 1000mg, 100mg/ml)
1
What is in this leaflet
1.
What KEPPRA is used for
2.
How KEPPRA works
3.
Before you use KEPPRA
4.
How to use KEPPRA
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of KEPPRA
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
11. Serial Number
What KEPPRA is used for
Keppra is used:
• on its own in adults and adolescents
from 16 years of age with a certain type
of newly diagnosed epilepsy. Epilepsy is
a condition where the patients have
repeated fits (seizures). Levetiracetam is
used for the epilepsy form in which the
fits initially affect only one side of the
brain, but could thereafter extend to
larger areas on both sides of the brain
(partial onset seizures with or without
secondary generalization). Keppra has
been given to you by your doctor to
reduce the number of fits.
• as an add-on to other antiepileptic
medicines to treat:
- partial onset seizures with or without
secondary generalization in adults and
children from 4 years of age with
epilepsy.
- myoclonic seizures (short, shock-like
jerks of a muscle or group of muscles)
in adults and adolescents from 12
years of age with juvenile myoclonic
epilepsy
- primary generalized tonic-clonic
seizures (major fits, including loss of
consciousness) in adults and children
from 12 years of age with Idiopathic
Generalized Epilepsy.
How KEPPRA works
Keppra is an antiepileptic medicine (a
medicine used to treat seizures in
epilepsy).
Before you use KEPPRA
- When you must not use it
Do not take Keppra
• If you are allergic to levetiracetam,
pyrrolidone derivatives or any of the
other ingredients of this medicine (see
section Product Description).
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think
you may be pregnant or are planning to
have a baby, ask your doctor for advice
before taking this medicine.
Keppra can be used during pregnancy,
only if a

Đặc tính sản phẩm

Page 1 of 20
[GSK Logo]
KEPPRA
Levetiracetam
NAME OF THE MEDICINAL PRODUCT
Levetiracetam, 250 mg, film-coated tablet
Levetiracetam, 500 mg, film-coated tablet
Levetiracetam, 1000 mg, film-coated tablet
Levetiracetam, 100 mg/ml, oral solution
Levetiracetam, 100 mg/ml, concentrate for solution for infusion
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam, 250 mg, film-coated tablet
Each film-coated tablet contains 250 mg of levetiracetam.
Levetiracetam, 500 mg, film-coated tablet
Each film-coated tablet contains 500 mg of levetiracetam.
Levetiracetam, 1000 mg, film-coated tablet
Each film-coated tablet contains 1000 mg of levetiracetam.
Levetiracetam, 100 mg/ml, oral solution
Each ml contains 100 mg of levetiracetam.
Levetiracetam, 100 mg/ml, concentrate for solution for infusion
Each ml contains 100 mg of levetiracetam.
Excipients
Levetiracetam, 250 mg, film-coated tablet
Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica,
Magnesium stearate,
Opadry 85F20694 Blue: Polyvinyl alcohol, Titanium dioxide (E171),
Macrogol/PEG
3350, Talc, FD&C blue #2/Indigo carmine aluminium lake (E132)
Levetiracetam, 500 mg, film-coated tablet
Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica,
Magnesium stearate,
Opadry 85F32004 Yellow: Polyvinyl alcohol, Titanium dioxide (E171),
Macrogol/PEG
3350, Talc, Iron oxide yellow (E172)
Levetiracetam, 1000 mg, film-coated tablet
Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica,
Magnesium stearate,
Opadry 85F18422 White: Polyvinyl alcohol, Titanium dioxide (E171),
Macrogol/PEG
3350, Talc
Levetiracetam, 100 mg/ml, oral solution
Sodium citrate, Citric acid monohydrate, Methyl parahydroxybenzoate
(E218), Propyl
parahydroxybenzoate (E216), Ammonium glycyrrhizate, Glycerol 85 per
cent (E422),
Page 2 of 20
Maltitol liquid (E965), Acesulfame potassium (E950), Grape flavor
Firmenich 501040A,
Purified water.
Levetiracetam, 100 mg/ml, concentrate for solution for infusion
Sodium acetate trihydrate, Glacial acetic acid, Sodium chloride, Water
for injectio