Levetiracetam Thame 100 mg/ml oral solution

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Levetiracetam

Boleh didapati daripada:

SYRI Limited, t/a Thame Laboratories

Kod ATC:

N03AX; N03AX14

INN (Nama Antarabangsa):

Levetiracetam

Dos:

100 milligram(s)/millilitre

Borang farmaseutikal:

Oral solution

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Other antiepileptics; levetiracetam

Status kebenaran:

Not marketed

Tarikh kebenaran:

2015-08-28

Risalah maklumat

VAR/IB-012
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVETIRACETAM THAME 100MG/ML ORAL SOLUTION
(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.
The name of your medicine is Levetiracetam Thame 100mg/ml Oral
Solution but it will be referred to
as Levetiracetam throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1.
WHAT LEVETIRACETAM IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVETIRACETAM
3.
HOW TO TAKE LEVETIRACETAM
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LEVETIRACETAM
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT LEVETIRACETAM IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam can be 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 (short, shock-like jerks of a muscle or group of
muscles) in adul

Ciri produk

Health Products Regulatory Authority
14 March 2019
CRN008SR3
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levetiracetam Thame 100 mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam Oral Solution contains the active ingredient,
Levetiracetam.
Each ml of oral solution contains 100mg Levetiracetam.
Excipients with known effect:
Each ml solution contains 1mg methyl parahydroxybenzoate (E218), 300mg
liquid maltitol (E965), 9.61mg propylene glycol
(E1520) and 11.68mg sodium citrate (E331) equivalent to 2.74mg of
sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Clear, colourless or pale yellow to pale brown colour solution with
grape flavour.
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 250mg (2.5ml) twice daily which
should be increased to an initial therapeutic dose of
500mg (5ml) twice daily after two weeks. The dose can be further
increased by 250mg (2.5ml) twice daily every two weeks
depending upon the clinical response. The maximum dose is 1500mg
(15ml) twice daily.
_Add-on therapy for adults (≥18 years) and adolescents (12 to 17
years) weighing 50kg or more_
The initial therapeutic do