Levetiracetam Thame 100 mg/ml oral solution

দেশ: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Levetiracetam

থেকে পাওয়া:

Syri Pharma Limited t/a Thame Laboratories

এটিসি কোড:

N03AX; N03AX14

INN (আন্তর্জাতিক নাম):

Levetiracetam

ডোজ:

100 milligram(s)/millilitre

ফার্মাসিউটিকাল ফর্ম:

Oral solution

থেরাপিউটিক এলাকা:

Other antiepileptics; levetiracetam

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

2015-08-28

তথ্য লিফলেট

VAR/IB-020
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 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 (short, shock-like jerks of a muscle or group of
muscles) in adults and

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
21 March 2024
CRN00F3PY
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
_Partial onset seizures_
The recommended dosing_ for _monotherapy (_from 16 years of age_) and
adjunctive _therapy _is the same; as outlined below.
_All indications_
_ _
_Adults (≥18 years) and adolescents (12 to 17 years) weighing 50kg
or more_
The initial therapeutic dose is 500mg (5ml) twice daily. This dose can
be started on the first day of treatment. However, a lower
initial dose of 250mg (2.5ml) twice daily may be given based on
physician assessment of seizure reduction versus potential