KEPPRA TABLET 250 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

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Indlægsseddel Indlægsseddel (PIL)
18-03-2014
Produktets egenskaber Produktets egenskaber (SPC)
07-11-2023

Aktiv bestanddel:

LEVETIRACETAM

Tilgængelig fra:

GLAXOSMITHKLINE PTE LTD

ATC-kode:

N03AX14

Dosering:

250 mg

Lægemiddelform:

TABLET, FILM COATED

Sammensætning:

LEVETIRACETAM 250 mg

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

UCB Pharma SA

Autorisation status:

ACTIVE

Autorisation dato:

2001-09-28

Indlægsseddel

                                1 | 
P a g e
 
 
 
_KEPPRA_
_®_
_                                             
                                             
          [GSK LOGO]_
_ _
_ _
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 
                                
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Produktets egenskaber

                                1 | P a g e
_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, 100 mg/ml, oral solution
A clear liquid.
Levetiracetam, 100 mg/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,
                                
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