Levetiracetam FAIR-MED HEALTHCARE 250mg film-coated Tablets

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 250 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

LEVETIRACETAM 250 mg

Prescription type:

POM

Therapeutic area:

ANTIEPILEPTICS

Authorization status:

Withdrawn

Authorization date:

2011-09-12

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
LEVETIRACETAM FAIR-MED HEALTHCARE 250 MG FILM-COATED TABLETS
LEVETIRACETAM FAIR-MED HEALTHCARE 500 MG FILM-COATED TABLETS
LEVETIRACETAM FAIR-MED HEALTHCARE 750 MG FILM-COATED TABLETS
LEVETIRACETAM FAIR-MED HEALTHCARE 1000 MG FILM-COATED TABLETS
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.
-
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. This
includes any possible side
effects not listed in this leaflet .See section 4.
_ _
WHAT IS IN THIS LEAFLET:
1.
What Levetiracetam Fair-Med Healthcare is and what it is used for
2.
What you need to know 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.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM FAIR-MED HEALTHCARE IS AND WHAT IT IS USED FOR
Levetiracetam Fair-Med Healthcare film-coated tabltes are an
antiepileptic medicine (a medicine
used to treat seizures in epilepsy).
Levetiracetam Fair-Med Healthcare is used alone in the treatment of
partial seizures in patients
from 16 years of age.

Levetiracetam Fair-Med Healthcare is used in patients who are already
taking another
antiepileptic medicine_ _

in the treatment of partial seizures in adults, children and infants
from 1 month age

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
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2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVETIRACETAM FAIR-MED
HEA

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Levetiracetam Fair-Med Healthcare 250 mg film-coated tablets.
Levetiracetam Fair-Med Healthcare 500 mg film-coated tablets.
Levetiracetam Fair-Med Healthcare 750 mg film-coated tablets.
Levetiracetam Fair-Med Healthcare 1000 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg levetiracetam.
Each film-coated tablet contains 500 mg levetiracetam.
Each film-coated tablet contains 750 mg levetiracetam.
Each film-coated tablet contains 1000 mg levetiracetam.
Excipients:
750 mg:
Levetiracetam Fair-Med Healthcarefilm-coated tablets contains 0.375 mg
Sunset Yellow
Aluminium Lake (E110)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
250 mg: Blue, oval shaped film coated tablets with a break line on one
side with dimensions 12.9 x
6.1 mm. The tablet can be divided into equal halves.
500 mg: Yellow, oval shaped film coated tablets with a break line on
one side with dimensions 16.5
x 7.7 mm. The tablet can be divided into equal halves.
750 mg: Orange, oval shaped film coated tablets with a break line on
one side with dimensions 18.8
x 8.9 mm. The tablet can be divided into equal halves.
1000 mg: White, oval shaped film coated tablets with a break line on
one side with dimensions 19.2
x 10.2 mm. The tablet can be divided into equal halves.
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 adults and
adolescents 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,
adolescents, children and infants from 1 month of age with epilepsy.
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
in the treatment of myoclonic seizures in adults and adolescents from
12 years of age wi