Levetiracetam 250mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVETIRACETAM

Available from:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

ATC code:

N03AX14

INN (International Name):

LEVETIRACETAM 250 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LEVETIRACETAM 250 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Withdrawn

Authorization date:

2015-02-27

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Levetiracetam 250 mg film-coated tablets
Levetiracetam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 doctoror 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 pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Levetiracetam tablet is and what it is used for
2.
What you need to know before you take Levetiracetam tablet
3.
How to take Levetiracetam tablet
4.
Possible side effects
5.
How to store Levetiracetam tablet
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM TABLET IS AND WHAT IT IS USED FOR
Levetiracetam 250 mg film-coated tablets are an antiepileptic medicine
(a medicine used to treat
seizures in epilepsy).
Levetiracetam tablet is used:

on its own in adults and adolescents from 16 years of age with newly
diagnosed epilepsy, to
treat partial onset seizures with or without secondary generalisation

As an add-on to other antiepileptic medicines to treat:
o
partial onset seizures with or without generalisation in adults,
adolescents, children and
infants from one month of age
o
myoclonic seizures in adults and adolescents from 12 years of age with
juvenile myoclonic
epilepsy
o
primary generalised tonic-clonic seizures in adults and adolescents
from 12 years of age
with idiopathic generalised epilepsy
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVETIRACETAM TABLET
_ _
DO NOT TAKE LEVETIRACETAM TABLET
2
-
If you are allergic (hypersensitive) to levetiracetam or any of the
other ingredients of this
medicine (listed in Section 6)
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Levetiracetam tablet

If you suffer from kidne

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam 250 mg film-coated tablet
Levetiracetam 500 mg film-coated tablet
Levetiracetam 750 mg film-coated tablet
Levetiracetam 1000 mg film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg levetiracetam, 500 mg
levetiracetam, 750 mg
levetiracetam or 1000 mg levetiracetam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
250 mg: Light blue, capsule shaped, biconvex, length: 12.9 mm to 13.3
mm, width: 5.9 mm to
6.3 mm and thickness: 4.2 mm to 4.8 mm, film-coated tablets plain on
both sides.
500 mg: Yellow, capsule shaped, biconvex, length: 17.4 mm to 17.8 mm,
width: 7.4 mm to 7.8
mm and thickness: 5.3 mm to 5.9 mm, film-coated tablets plain on both
sides.
750 mg: Light pink, capsule shaped, biconvex, length: 19.4 mm to 19.8
mm, width: 8.0 mm to
8.4 mm and thickness: 6.3 mm to 6.9, mm, film-coated tablets plain on
both sides.
1000 mg: White, capsule shaped, biconvex, length: 20.9 mm to 21.3 mm,
width: 8.9 mm to 9.3
mm and thickness: 7.3 mm to 7.9 mm, film-coated tablets plain on both
sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam is indicated as monotherapy in the treatment of partial
onset seizures with or
without secondary generalisation in adults and adolescents from 16
years of age with newly
diagnosed epilepsy.
Levetiracetam is indicated as adjunctive therapy

in the treatment of partial onset seizures with or without secondary
generalisation in adults
adolescents, children and infants from 1 month of age with epilepsy

in the treatment of myoclonic seizures in adults and adolescents from
12 years of age with
Juvenile Myoclonic Epilepsy
2

in the treatment of primary generalised tonic-clonic seizures in
adults and adolescents from 12
years of age with Idiopathic Generalised Epilepsy
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Monotherapy for adults and adolescents from 16 years of age _
The recommended starting dose is 250 mg twice daily