Levetiracetam Wockhardt 100 mg/ml oral solution

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Levetiracetam

Предлага се от:

Pinewood Laboratories Ltd

АТС код:

N03AX; N03AX14

INN (Международно Name):

Levetiracetam

дозиране:

100 milligram(s)/millilitre

Лекарствена форма:

Oral solution

Терапевтична област:

Other antiepileptics; levetiracetam

Статус Оторизация:

Not marketed

Дата Оторизация:

2011-06-29

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM WOCKHARDT 100 MG/ML ORAL SOLUTION
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. 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 effect please tell your doctor or pharmacist.
This includes possible side effects
not listed in this leaflet. See section 4
Levetiracetam Wockhardt 100 mg/ml Oral Solution is referred to as
Levetiracetam Oral Solution
throughout this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Levetiracetam Oral Solution is and what it is used for
2. What you need to know before you take Levetiracetam Oral Solution
3. How to take Levetiracetam Oral Solution
4. Possible side effects
5. How to store Levetiracetam Oral Solution
6. Contents of the pack and other information
1. WHAT LEVETIRACETAM ORAL SOLUTION IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Oral Solution 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 musc

Данни за продукта

Health Products Regulatory Authority
04 January 2021
CRN009Z4T
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levetiracetam Wockhardt 100 mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml contains 100 mg levetiracetam.
Excipients with known effect:
Each ml also contains liquid maltitol 269.4 mg (approximately 106 mg
of maltitol), methyl parahydroxybenzoate (E218) 1.4 mg
and propyl parahydroxybenzoate (E216) 0.2 mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Clear to slightly yellow oral solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levetiracetam 100mg/ml Oral Solution, is indicated as monotherapy in
the treatment of partial onset seizures with or without
secondary generalisation in patients from 16 years of age with newly
diagnosed epilepsy.
Levetiracetam 100mg/ml Oral Solution, is indicated as adjunctive
therapy

in the treatment of partial onset seizures with or without secondary
generalisation in adults, 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 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 inc