LEVETIRACETAM 100 Mg/Ml Oral Solution

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

LEVETIRACETAM

Disponible desde:

Rosemont Pharmaceuticals Ltd

Designación común internacional (DCI):

LEVETIRACETAM

Dosis:

100 Mg/Ml

formulario farmacéutico:

Oral Solution

tipo de receta:

Product subject to prescription which may be renewed (B)

Estado de Autorización:

Authorised

Fecha de autorización:

0000-00-00

Información para el usuario

LEVETIRACETAM 100MG/ML ORAL SOLUTION 
100MG/ML
P0652
P0623
-
-
180 x 400mm (folded 180 x 33mm)  
ONE 

Rosemont

ROSEMONT PHARMACEUTICALS LTD. PRINTED PACKAGING ORIGINATION AND
APPROVAL
TM
PRODUCT:
STRENGTH:
NEW ITEM CODE:
PREVIOUS ITEM CODE:
DESIGN ICON:
CUTTER REF:
DIMENSIONS:
NUMBER OF  
COLOURS USED:
Black
New Pharmacode:
Barcode:
Keyline
SUGAR-FREE
PACK SIZE
YES
150ML 
300ML
Date:                      14.06.13
Proof Number:       THREE
Page:                     1  of: 1
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applicable  
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

LEVETIRACETAM 100MG/ML ORAL SOLUTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

n
  Keep this leaflet. You may need to read it again. 
n
  If you have any further questions, ask your doctor or
pharmacist. 
n
  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. 
n
  If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in 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 100mg/ml Oral Solution is an anti-epileptic medicine (a
medicine used to treat seizures in epilepsy).
Levetiracetam is used: 
n
  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. 
n
  as an add-on to other antiepileptic medicines to treat: 
  -  partial onset seizures with or without generalisation

Ficha técnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Levetiracetam 100mg/ml oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1ml of solution contains 100mg Levetiracetam.
Excipients with known effect:
Methyl Hydroxybenzoate - 2.7mg/ml
Propyl Hydroxybenzoate - 0.3mg/ml
Liquid Maltitol – 0.3g/ml
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Solution
A clear colourless solution
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 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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