LEVETIRACETAM CIPLA 500 Milligram Film Coated Tablet

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

LEVETIRACETAM

Fáanlegur frá:

Cipla (EU) Limited

ATC númer:

N03AX14

INN (Alþjóðlegt nafn):

LEVETIRACETAM

Skammtar:

500 Milligram

Lyfjaform:

Film Coated Tablet

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Other antiepileptics

Leyfisstaða:

Authorised

Leyfisdagur:

2015-01-30

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Levetiracetam Cipla 500 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 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 Cipla is and what it is used for
2.
What you need to know before you take Levetiracetam Cipla
3.
How to take Levetiracetam Cipla
4.
Possible side effects
5.
How to store Levetiracetam Cipla
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM CIPLA IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Cipla 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 Cipla 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 Cipla 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 month of age
o
myoclonic seizures (short, shock-like jerks of a muscle or group of
muscles) in adults and
adolescents from 12 years of age with juvenile myoclonic epilepsy
o
primary generalised tonic-clonic sei

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levetiracetam Cipla 500mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 500 mg levetiracetam.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
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.
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
•
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_
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 twice daily. Dose
changes can be made in 500 mg twice daily increases or decreases every
two to four weeks.
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