LEVETIRACETAM VIATRIS levetiracetam 1000 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam, Quantity: 1000 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

Levetiracetam

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: colloidal anhydrous silica; povidone; magnesium stearate; croscarmellose sodium; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

LEVETIRACETAM VIATRIS tablets 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 generalised tonic-clonic seizures (PGTC) in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE).

Product summary:

Visual Identification: White to off white, oval biconvex, Film coated tablets, debossed " L 67" with breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-04-20

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
Version 1
2020 Page: 1 of 5
LEVETIRACETAM MYLAN TABLETS 250 MG/500 MG/1000 MG
levetiracetam
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
LEVETIRACETAM MYLAN tablets.
It does not contain all the
available information. It does not
take the place of talking to your
physician or pharmacist.
All drugs have risks and benefits.
Your physician has weighed the
risks of you taking
LEVETIRACETAM MYLAN tablets
against the benefits they expect
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS DRUG, ASK YOUR
PHYSICIAN OR PHARMACIST.
KEEP THIS LEAFLET WITH THE DRUG.
You may need to read it again.
WHAT LEVETIRACETAM
MYLAN TABLETS ARE
USED FOR
LEVETIRACETAM MYLAN tablets
are 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.
LEVETIRACETAM MYLAN tablets
belong to a group of drugs called
antiepileptics.
These drugs are thought to work
by controlling brain chemicals
which send signals to nerves so
that seizures do not happen.
LEVETIRACETAM MYLAN tablets
may be used alone or in
combination with other drugs, to
treat your condition.
Your physician may have
prescribed LEVETIRACETAM
MYLAN tablets in addition to
your current therapy.
ASK YOUR PHYSICIAN IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
LEVETIRACETAM MYLAN
TABLETS HAVE BEEN PRESCRIBED
FOR YOU.
There is no evidence that
LEVETIRACETAM MYLAN tablets
are addictive.
This drug is available only with a
physician’s prescription.
The safety and effectiveness of
LEVETIRACETAM MYLAN tablets
has not been established in
patients less than 4 years of
age.
BEFORE YOU TAKE
LEVETIRACETAM
MYLAN TABLETS
WHEN YOU MUST NOT TAKE
IT
DO NOT TAKE LEVETIRACETAM
MYLAN TABLETS 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 par

Summary of Product characteristics

LEVETIRACETAM MYLAN
PI v1
AUSTRALIAN PRODUCT INFORMATION
LEVETIRACETAM MYLAN 250/500/1000
(LEVETIRACETAM) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The product LEVETIRACETAM MYLAN contain levetiracetam as the active
ingredient. LEVETIRACETAM
MYLAN are available in three strengths 250 mg, 500 mg, and 1000 mg.
For the full list of Excipients, see Section 6.1 List of Excipients
3
PHARMACEUTICAL FORM
LEVETIRACETAM MYLAN 250 (AUST R 189885): are white to off white
tablets, oval biconvex, film
coated tablets, debossed ‘L 64’ and breakline on one side and
plain on the other side.
LEVETIRACETAM MYLAN 500 (AUST R 189886): are yellow coloured tablets,
oval biconvex, film coated
tablets, debossed ‘L 65’ and breakline on one side and plain on
the other side.
LEVETIRACETAM MYLAN 1000 (AUST R 1898877): are white to off white
tablets , oval biconvex, film
coated tablets, debossed ‘L 67’ and breakline on one side and
plain on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
LEVETIRACETAM MYLAN 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 generalised tonic-clonic
seizures (PGTC) in adults
and children from 4 years of age with idiopathic generalised epilepsy
(IGE).
4.2
D
OSE AND METHOD OF ADMINISTRATION
LEVETIRACETAM MYLAN
PI v1
The film coated tablets must be taken orally, swallowed with liquid.
The film coated tablets may be
taken with or without food. The daily dose is administered in two
equally divided doses.
MONOTHERAPY:
The recommended startin