KEPPRA TABLET 1000 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

LEVETIRACETAM

Available from:

GLAXOSMITHKLINE PTE LTD

ATC code:

N03AX14

Dosage:

1000 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

LEVETIRACETAM 1000 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

UCB Pharma SA

Authorization status:

ACTIVE

Authorization date:

2001-09-28

Patient Information leaflet

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P a g e

_KEPPRA_
_®_
_                                             

          [GSK LOGO]_
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PHARMACEUTICAL FORM AND STRENGTH 

Each film-coated tablet contains 250 mg, 500 mg or 1000 mg levetiracetam. 
250 mg 
The  film-coated tablets are
blue, oblong,  scored and debossed with the code “ucb 
250” on one side 
500 mg 
The film-coated tablets are
yellow, oblong, scored and debossed with the code “ucb 
500” on one side 
1000 mg 
The film-coated tablets  are  white, oblong, scored and debossed with the
code “ucb 
1000” on one side 

Oral solution: Clear liquid. Each ml
contains 100 mg levetiracetam. 

Concentrate for solution for infusion:
Clear, colourless, sterile solution. Each ml contains 100 mg 
levetiracetam. 

EXCIPIENTS 

_Keppra Tablet 250 mg _
Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate, Opadry 
85F20694
(Polyvinyl alcohol-part.hydrolysed, Titanium dioxide (E171), Macrogol 3350, Talc, Indigo 
carmine aluminium lake (E132)) 
_ _
_Keppra Tablet 500 mg _
Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate, Opadry 
85F32004
(Polyvinyl alcohol-part. hydrolysed, Titanium dioxide (E171), Macrogol 3350, Talc, Iron 
oxide yellow (E172)) 
_ _
_Keppra Tablet 1000 mg _
Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica, Magnesium stearate, Opadry 
85F18422
(Polyvinyl alcohol-part. hydrolysed, Titanium dioxide (E171), Macrogol 3350, Talc) 

_Keppra Oral Solution 100 mg/ml _
Sodium citrate, Citric acid monohydrate, Methyl parahydroxybenzoate (E218), Propyl 
parahydroxybenzoate (E216), Ammonium glycyrrhizate, Glycerol (E422), Maltitol (E965), 
Acesulfame potassium (E950), Grape flavour, Purified Water 

Summary of Product characteristics

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_KEPPRA_
_ [GSK LOGO]_
_ _
_ _
PHARMACEUTICAL FORM AND STRENGTH
Levetiracetam, 250 mg, film-coated tablets
Blue, oblong film-coated tablet scored and debossed with the code ucb
and 250 on one side. The score
line does not break the tablet into equal halves and is not intended
for dividing the tablet into half-doses
for administration. It only serves to facilitate breaking for ease of
swallowing.
Levetiracetam, 500 mg, film-coated tablets
Yellow, oblong film-coated tablet scored and debossed with the code
ucb and 500 on one side. The
score line does not break the tablet into equal halves and is not
intended for dividing the tablet into
half-doses for administration. It only serves to facilitate breaking
for ease of swallowing.
Levetiracetam, 1000 mg, film-coated tablets
White, oblong film-coated tablet scored and debossed with the code ucb
and 1000 on one side. The
score line does not break the tablet into equal halves and is not
intended for dividing the tablet into
half-doses for administration. It only serves to facilitate breaking
for ease of swallowing.
Levetiracetam, 100mg/ml, oral solution
A clear liquid.
Levetiracetam, 100mg/ml, concentrate for solution for infusion
Clear and colourless solution free from visible particulate matter.
EXCIPIENTS
_Keppra Tablet 250 mg _
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)
_ _
_Keppra Tablet 500 mg _
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)
_ _
_Keppra Tablet 1000 mg _
Sodium croscarmellose, Macrogol 6000, Colloidal anhydrous silica,
Magnesium stearate, Opadry
85F18422 White: Polyvinyl alcohol, Titanium dioxide (E171),
Macrogol/PEG 3350, Talc
_Keppra Oral Solution 100 mg/ml _
Sodium citrate, Citric acid monohydrate, M