Levetiracetam Fair-Med Healthcare 100mg/ml oral solution

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LEVETIRACETAM

Available from:

FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany

ATC code:

N03AX14

INN (International Name):

LEVETIRACETAM 100 mg/ml

Pharmaceutical form:

ORAL SOLUTION

Composition:

LEVETIRACETAM 100 mg/ml

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Withdrawn

Authorization date:

2011-09-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 
_ _
LEVETIRACETAM FAIR-MED HEALTHCARE 100 MG/ML ORAL SOLUTION 
Levetiracetam 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
- 
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 symptoms are the same as yours. 
- 
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, 
please tell your doctor or pharmacist. 
_ _
IN THIS LEAFLET:      
1. 
What Levetiracetam Fair-Med Healthcare is and what it is used for 
2. 
Before you take Levetiracetam Fair-Med Healthcare 
3. 
How to take Levetiracetam Fair-Med Healthcare 
4. 
Possible side effects 
5. 
How to store Levetiracetam Fair-Med Healthcare 
6. 
Further information 

1. 
WHAT LEVETIRACETAM  FAIR-MED HEALTHCARE IS AND WHAT IT IS USED FOR 

Levetiracetam Fair-Med Healthcare is an antiepileptic medicine
(a medicine used to treat seizures in 
epilepsy). 

Levetiracetam Fair-Med Healthcare is used:  
  on its own in patients from 16 years of age with newly
diagnosed epilepsy, to  
treat partial onset seizures with or without secondary
generalisation. 
  as an add-on treatment to other antiepileptic medicines to
treat: 
  partial onset seizures with or without generalisation in
patients from one month of age 
  myoclonic seizures in patients from 12 years of age with
juvenile myoclonic epilepsy. 
  primary generalised tonic-clonic seizures in patients
from 12 years of age with idiopathic 
generalised epilepsy 

2. 
BEFORE YOU TAKE LEVETIRACETAM FAIR-MED HEALTHCARE 

DO NOT TAKE LEVETIRACETAM FAIR-MED HEALTHCARE 
  If you are allergic ( hypersensitive) to levetiracetam or
any of the other ingredients of 
Levetiracetam Fair-Med Healthcare. 

TAKE SPECIAL CARE WIT

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Levetiracetam Fair-Med Healthcare 100 mg/ml oral solution. 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each ml contains 100 mg levetiracetam 

Excipients: Each ml contains 300 mg maltitol liquid and
2.5 mg methyl parahydroxybenzoate 
(E218).  

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 

Oral solution 
Clear liquid 

4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

Levetiracetam Fair-Med Healthcare 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 Fair-Med Healthcare 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. 

Page 1 of 18 

_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 and tolerability, the
daily dose can be i