KEVTAM 1000 levetiracetam 1000 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam, Quantity: 1000 mg

Available from:

Alphapharm Pty Ltd

INN (International Name):

Levetiracetam

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; maize starch; titanium dioxide; hypromellose; macrogol 6000

Administration route:

Oral

Units in package:

60, 10, 100

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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: White, capsule shaped, biconvex film coated tablets plain on both sides; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2016-11-21

Patient Information leaflet

KEVTAM
_levetiracetam_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about KEVTAM.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking KEVTAM against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT KEVTAM IS USED
FOR
KEVTAM levetiracetam is used to
treat 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.
KEVTAM 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.
Your doctor may have prescribed it
for another reason.
There is no evidence that this
medicine is addictive
This medicine is available only with
a doctor's prescription.
The safety and effectiveness of
KEVTAM has not been established
in patients less than 4 years of age.
BEFORE YOU TAKE
KEVTAM
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE KEVTAM 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
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING OR IF THE TABLETS
DO NOT LOOK QUITE RIGHT.
If it has expire

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
KEVTAM 250
KEVTAM 500
KEVTAM 1000
_Levetiracetam film-coated tablets _
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam 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 g/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.
Each KEVTAM 250 film-coated tablet contains 250 mg of levetiracetam.
Each KEVTAM 500 film-coated tablet contains 500 mg levetiracetam.
Each KEVTAM 1000 film-coated tablet contains 1000 mg levetiracetam.
For the full list of excipients, see Section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Film-coated tablets.
KEVTAM 250: Light blue, capsule shaped, biconvex film coated tablets
plain on both sides.
KEVTAM 500: Yellow, capsule shaped, biconvex film coated tablets plain
on both sides.
KEVTAM 1000: White, capsule shaped, biconvex film coated tablets plain
on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
KEVTAM 250, KEVTAM 500 and KEVTAM 1000 are 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).
Kevtam 250, Kevtam 500 and Kevtam 1000 – AUSTRALIAN PRODUCT
INFORMATION
_2 _
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
Levetiracetam therapy can be initiated with either intravenous or oral
admin