Levetiracetam Accord 100mg/ml Oral Solution (150ml vial)

Țară: Malta

Limbă: engleză

Sursă: Malta Medicines Authority

Ingredient activ:

LEVETIRACETAM

Disponibil de la:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

Codul ATC:

N03AX14

INN (nume internaţional):

LEVETIRACETAM 100 mg/ml

Forma farmaceutică:

ORAL SOLUTION

Compoziție:

LEVETIRACETAM 100 mg/ml

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTIEPILEPTICS

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2018-02-12

Prospect

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVETIRACETAM 100 MG/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 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 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
adolescents from 12 years of age with ju

Caracteristicilor produsului

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SUMMARY OF PRODUCT CHARACTERISTICS
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.
pH 5.0 to 7.0
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.
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Depending upon the clinical response and tolerability, the daily dose
can be inc