Levetiracetam 100mgml oral solution sugar free

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Levetiracetam

Available from:

Accord Healthcare Ltd

ATC code:

N03AX14

INN (International Name):

Levetiracetam

Dosage:

100mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5055565718797

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVETIRACETAM 100 MG/ML ORAL SOLUTION
Levetiracetam
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 or
nurse.
-
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 or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
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 oral solution 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 partial
onset seizures with or without secondary generalisation.

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 in adults and adolescents from 12 years of age with
juvenile myoclonic epilepsy
-
primary generalised tonic-clonic seizures in adults and adolescents
from 12 years of age with
idiopathic generalised epilepsy
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVETIRACETAM ORAL SOLUTION
DO NOT TAKE LEVETIRACETAM ORAL SOLUTION

If you are allergic to levetiracetam or any of the other ingredients
of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist or nurse be

Summary of Product characteristics

OBJECT 1
LEVETIRACETAM ACCORD 100 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 06-Oct-2015 | Accord
Healthcare Limited
1. Name of the medicinal product
Levetiracetam Accord 100 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml contains 100 mg levetiracetam
Excipients with known effect: Each ml contains 1.5 mg of methyl
parahydroxybenzoate (E218), 0.18 mg
of propyl parahydroxybenzoate (E216) and 300 mg of maltitol liquid
(E965).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral solution.
A clear, colourless grape flavoured liquid.
4. Clinical particulars
4.1 Therapeutic indications
Levetiracetam Accord oral solution 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 Accord oral solution 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