LEVETIRACETAM-LUPIN levetiracetam 1000 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam

Available from:

Lupin Australia Pty Limited

INN (International Name):

Levetiracetam

Authorization status:

Registered

Patient Information leaflet

1
LEVETIRACETAM -LUPIN TABLETS 250 MG, 500 MG
AND 1000 MG.
Levetiracetam.
(Lupin Australia Pty. Ltd.)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Levetiracetam -Lupin
Tablets 250 mg,
500 mg and 1000 mg. It does not contain all the available information.
It does not take the
place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
Levetiracetam-Lupin Tablets 250 mg, 500 mg and 1000 mg against the
benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT LEVETIRACETAM-LUPIN TABLETS 250 MG,
500 MG AND 1000 MG IS USED FOR
Levetiracetam -Lupin Tablets 250 mg, 500 mg and 1000 mg is used to
control epilepsy.
2
Epilepsy is a condition where you have repeated seizures (fits). There
are many different
types of seizures, ranging from mild to severe.
Levetiracetam belongs to a group of medicines called antiepileptics.
These medicines are
thought to work by controlling brain chemicals which send signals to
nerves so that seizures
do not happen.
Levetiracetam -Lupin Tablets may be used alone, or in combination with
other medicines, to
treat your condition.
Your doctor may prescribe Levetiracetam -Lupin Tablets in addition to
your current therapy.
Ask your doctor if you have any questions about why Levetiracetam
-Lupin Tablets has been
prescribed for you.
There is no evidence that Levetiracetam -Lupin Tablets is addictive.
This medicine is available only with a doctor's prescription.
The safety and effectiveness of Levetiracetam-Lupin Tablets has not
been established in
patients less than 4 years of age.
BEFORE
YOU
TAKE
LEVETIRACETAM-LUPIN
TABLETS 250 MG, 500 MG AND 1000 MG.
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE LEVETIRACETAM -LUPIN TABLETS IF YOU HAVE AN ALLERGY TO:
•
any of the ingredients listed at the end of this leaflet
Symptoms of an allergic reac

Summary of Product characteristics

Levetiracetam-LUPIN Tablets
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Page 1 of 37
LEVETIRACETAM-LUPIN TABLETS
(LUPIN AUSTRALIA PTY. LTD)
NAME OF THE MEDICINE
Levetiracetam-LUPIN Tablets 250 mg, 500 mg and 1000 mg.
DESCRIPTION
Chemical name: (S)-alpha-ethyl-2-oxo-1-pyrrolidine acetamide.
Levetiracetam is a pure enantiomer. It is a white to off white powder
with a faint odour and a
bitter taste. It is very soluble in water (104 g/100 mL). It is freely
soluble in chloroform (65.3
mg/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5
g/100 mL), sparingly
soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in
n-hexane.
Molecular formula: C
8
H
14
N
2
O
2
Molecular Weight: 170.21
CAS: 102767-28-2.
Levetiracetam: Chemical structure.
Levetiracetam-LUPIN Tablets
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Page 2 of 37
Levetiracetam-Lupin
tablets contain Levetiracetam, and the inactive ingredients
starch-maize,
silica-colloidal
anhydrous,
Croscarmellose
sodium,
cellulose
microcrystalline,
magnesium
stearate, Povidone, Talc-purified.
Tablets are film-coated & the film coating for each strength is
different, as follows:
250mg – Opadry blue contains polyvinyl alcohol, talc, titanium
dioxide (E171), macrogol 6000 &
3350, and Indigo carmine CI73015
500mg – Opadry yellow contains polyvinyl alcohol, talc, titanium
dioxide (E171), macrogol 6000
& 3350, iron oxide yellow (CI77492)
1000mg – Opadry white contains polyvinyl alcohol, talc, titanium
dioxide (E171), macrogol 6000
& 3350.
PHARMACOLOGY
MECHANISM OF ACTION
The precise mechanism of action by which Levetiracetam induces seizure
protection still
remains to be fully elucidated, but appears to be unrelated to the
mechanisms of current
antiepileptic drugs. _In vitro _and _in vivo _experiments suggest that
Levetirace