KERRON 500 levetiracetam 500 mg tablets Bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
levetiracetam, Quantity: 500 mg
Available from:
Arrotex Pharmaceuticals Pty Ltd
INN (International Name):
Levetiracetam
Pharmaceutical form:
Tablet, film coated
Composition:
Excipient Ingredients: povidone; purified talc; magnesium stearate; colloidal anhydrous silica; maize starch; titanium dioxide; hypromellose; iron oxide yellow; macrogol 4000
Administration route:
Oral
Units in package:
30, 60
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
It is indicated for:,? use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation,,? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,? add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME),and,? add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).
Product summary:
Visual Identification: Yellow oval shaped biconvex film-coated tablets debossed with a deep break line separating 'E' and '11' on one side and plain on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2011-12-23
Patient Information leaflet
KERRON™
CONSUMER MEDICINE INFORMATION
Levetiracetam film-coated tablets and oral solution
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about KERRON.
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 KERRON
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 KERRON IS USED FOR
KERRON is used to control epilepsy.
Epilepsy is a condition where you have repeated seizures. There are
many different types of
seizures, ranging from mild to severe.
This medicine 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.
KERRON may be used alone, or in combination with other medicines, to
treat your condition.
Your doctor may have prescribed this medicine in addition to your
current therapy.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS
BEEN PRESCRIBED FOR
YOU.
There is no evidence that this medicine is addictive.
This medicine is available only with a doctor’s prescription.
The safety and effectiveness of KERRON has not been established in
patients less than 4 years of
age.
BEFORE YOU TAKE KERRON
_ _
_WHEN YOU MUST NOT TAKE IT: _
DO NOT TAKE KERRON IF YOU HAVE AN ALLERGY TO
ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET.
Some of the symptoms of an allergic reaction may include:
shortness of breath;
wheezing or difficulty breathing;
swelling of the face, lips, tongue or other parts of the body; or
rash, itching or hives on the skin.
KERRON ORAL SOLUTION CONTAINS MALTITOL. DO NOT USE THIS MEDICINE IF
YOU HAVE HEREDITARY
PROBLEMS OF FRUCTOSE INTOLERANCE.
DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE (EXP) PRINTED ON
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Summary of Product characteristics
Page 1 of 23
PRODUCT INFORMATION
KERRON (LEVETIRACETAM)
FILM-COATED TABLETS AND ORAL SOLUTION
NAME OF THE MEDICINE
Active ingredient:
Levetiracetam
Chemical name:
(2S)-2-(2-Oxopyrrolidin-1-yl)butanamide
CAS number:
102767-28-2
Molecular weight:
170.21
Molecular formula:
C
8
H
14
N
2
O
2
Chemical structure:
DESCRIPTION
Levetiracetam is white or almost white powder. It is very soluble in
water, soluble in acetonitrile,
practically insoluble in hexane.
KERRON is available as film coated tablets containing 250 mg, 500 mg,
750 mg & 1000 mg
levetiracetam and oral solution containing 100 mg levetiracetam per
mL.
KERRON tablets contain the following inactive ingredients: maize
starch, colloidal anhydrous
silica, povidone, purified talc & magnesium stearate.
250 mg tablet also contains Opadry OY-S-30913 Blue (PI-ARTG No.3804).
500 mg tablet also contains Opadry Complete Film Coating System
05F82840 Yellow (PI-ARTG
No.106470).
750 mg tablet also contains Opadry OY-S-33016 Orange (PI-ARTG
No.3803).
1000 mg tablet also contains Opadry White Y-1-7000 E171 (PI-ARTG
No.2731).
KERRON oral solution contains the following inactive ingredients:
sodium citrate, citric acid
monohydrate, methyl hydroxybenzoate, propyl hydroxybenzoate, propylene
glycol, glycerol,
maltitol solution, acesulfame potassium, mafco magnasweet 110, grape
flavour 50147 C and
purified water.
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 anti-epileptic
drugs. _ In vitro_ and _ in vivo_ experiments suggest that
levetiracetam does not alter basic cell
characteristics and normal neurotransmission.
Page 2 of 23
_In vitro_ studies show that levetiracetam affects intraneuronal Ca
2+
levels by partial inhibition of N-
type Ca
2+
currents and by reducing the release of Ca
2+
from intraneuronal stores. In addition, it
partially reverses the reductions in GABA- and glycine-gated currents
induced by zinc and β-
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