Levetiracetam Aurobindo 750 mg film-coated tablets

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Virkt innihaldsefni:

LEVETIRACETAM

Fáanlegur frá:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC númer:

N03AX13

INN (Alþjóðlegt nafn):

LEVETIRACETAM 750 mg

Lyfjaform:

FILM-COATED TABLET

Samsetning:

LEVETIRACETAM 750 mg

Gerð lyfseðils:

POM

Lækningarsvæði:

ANTIEPILEPTICS

Leyfisstaða:

Authorised

Leyfisdagur:

2016-10-24

Upplýsingar fylgiseðill

Page
1
of
7
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVETIRACETAM AUROBINDO 250 MG FILM-COATED TABLETS
LEVETIRACETAM AUROBINDO 500 MG FILM-COATED TABLETS
LEVETIRACETAM AUROBINDO 750 MG FILM-COATED TABLETS
LEVETIRACETAM AUROBINDO 1000 MG FILM-COATED TABLETS
levetiracetam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist.This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Levetiracetam Aurobindo is and what it is used for
2.
What you need to know before you take Levetiracetam Aurobindo
3.
How to take Levetiracetam Aurobindo
4.
Possible side effects
5.
How to store Levetiracetam Aurobindo
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM AUROBINDO IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Aurobindo is used
•
on its own in adults and adolescents from 16 years of age with newly
diagnosed epilepsy, to treat
a certain form of epilepsy. Epilepsy is a condition where the patients
have repeated fits (seizures).
Levetiracetam is used for the epilepsy form in which the fits
initially affect only one side of the
brain, but could thereafter extend to larger areas on both sides of
the brain (partial onset seizure
with or without secondary generalisation). Levetiracetam has been
given to you by your doctor to
reduce the number of fits.
•
as an add-on to other antiepileptic medicines to treat:
-
partial onset seizures with or without generalisation in adults,
adolescents, children and
infants from one month of age;
-
myoclonic seizures (sho

Vara einkenni

Page
1
of
17
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam Aurobindo 250 mg film-coated tablets
Levetiracetam Aurobindo 500 mg film-coated tablets
Levetiracetam Aurobindo 750 mg film-coated tablets
Levetiracetam Aurobindo 1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg levetiracetam.
Each film-coated tablet contains 500 mg levetiracetam.
Each film-coated tablet contains 750 mg levetiracetam.
Each film-coated tablet contains 1000 mg levetiracetam.
Excipient with known effect: [For 750mg only]
Each film-coated tablet contains 0.12 mg of sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_ _
Levetiracetam Aurobindo 250 mg film-coated tablets:
Blue oval shaped biconvex film-coated tablets debossed with a deep
break line separating ‘E’ and ‘10’
on one side and plain on the other side. The size is 14.7 mm X 6.9 mm.
The tablet can be divided into equal doses.
_ _
Levetiracetam Aurobindo 500 mg film-coated tablets:
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. The size is 18.3 mm
X 8.0 mm.
The tablet can be divided into equal doses.
_ _
_ _
Levetiracetam Aurobindo 750 mg film-coated tablets:
Orange oval shaped biconvex film-coated tablets debossed with a deep
break line separating ‘E’ and
‘12’ on one side and plain on the other side. The size is 19.8 mm
X 9.2 mm.
The tablet can be divided into equal doses.
_ _
_ _
Levetiracetam Aurobindo 1000 mg film-coated tablets:
White modified oval shaped, biconvex film-coated tablets debossed with
a deep break line separating
‘E’ and ‘13’ on one side and plain on the other side. The size
is 22.5 mm X 10.7 mm.
The tablet can be divided into equal doses.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam is indicated as monotherapy in the treatment of partial
onset seizure