Levetiracetam Wockhardt 1000mg Film-Coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVETIRACETAM

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

N03AX14

INN (International Name):

LEVETIRACETAM 1000 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LEVETIRACETAM 1000 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Withdrawn

Authorization date:

2013-06-03

Patient Information leaflet

Page
1
of
6
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM WOCKHARDT 250MG, 500MG, 750MG AND 1,000MG FILM-COATED
TABLETS
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.
The name of your medicine is Levetiracetam Wockhardt 250mg, 500mg,
750mg and 1,000mg Film-Coated
Tablets. In the rest of the leaflet it is called Levetiracetam
Tablets.
WHAT IS IN THIS LEAFLET:
1. What Levetiracetam Tablets are and what they are used for
2. What you need to know before you take Levetiracetam Tablets
3. How to take Levetiracetam Tablets
4. Possible side effects
5. How to store Levetiracetam Tablets
6. Contents of the pack and other information
1. WHAT LEVETIRACETAM TABLETS ARE AND WHAT THEY ARE USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Tablets are used:
•
on their 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:
o
partial onset seizures with or without generalisation in adults,
adolescents, children and infants
from one

Summary of Product characteristics

Page
1
of
17
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Levetiracetam Wockhardt
_ _
1000mg Film-Coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1000mg of levetiracetam.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, film-coated, oval shaped tablets, debossed with “W535” on
one side and a score line
on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into
equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam tablets are 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 tablets are 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.
•
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 which should be
increased to an
initial therapeutic dose of 500 mg twice daily after two weeks. The
dose can be further
increased by 250 mg twice daily every two weeks depending upon the
clinical response. The
maximum dose is 1500 mg twice daily.
_Add-on therapy for adults (_
_18 years) and adolescents (12 to 17 years) weighing 50 kg or _
_more_
Page
2
of
17
The initial therapeutic dose is 500 mg twice daily. This dose can be
started on the first day
of treatment.
Depending upon the clinical response and tolerability, the daily dose
can be increased up to
1,500 mg