Levetiracetam Actavis

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

levetiracetam

Διαθέσιμο από:

Actavis Group PTC ehf

Φαρμακολογική κατηγορία (ATC):

N03AX14

INN (Διεθνής Όνομα):

levetiracetam

Θεραπευτική ομάδα:

Antiepileptics,

Θεραπευτική περιοχή:

Epilepsy

Θεραπευτικές ενδείξεις:

Levetiracetam Actavis 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 Actavis is indicated as adjunctive therapy:in the treatment of partial-onset seizures with or without secondary generalisation in adults, children and infants from one 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.

Περίληψη προϊόντος:

Revision: 19

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-10-03

Φύλλο οδηγιών χρήσης

53
B. PACKAGE LEAFLET
54
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
LEVETIRACETAM ACTAVIS 250 MG FILM-COATED TABLETS
LEVETIRACETAM ACTAVIS 500 MG FILM-COATED TABLETS
LEVETIRACETAM ACTAVIS 750 MG FILM-COATED TABLETS
LEVETIRACETAM ACTAVIS 1000 MG FILM-COATED TABLETS
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.
-
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 Actavis is and what it is used for
2.
What you need to know before you take Levetiracetam Actavis
3.
How to take Levetiracetam Actavis
4.
Possible side effects
5.
How to store Levetiracetam Actavis
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM ACTAVIS IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Actavis 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 seizu

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam Actavis 250 mg film-coated tablets
Levetiracetam Actavis 500 mg film-coated tablets
Levetiracetam Actavis 750 mg film-coated tablets
Levetiracetam Actavis 1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam Actavis 250 mg film-coated tablets
Each film-coated tablet contains 250 mg levetiracetam.
Levetiracetam Actavis 500 mg film-coated tablets
Each film-coated tablet contains 500 mg levetiracetam.
Levetiracetam Actavis 750 mg film-coated tablets
Each film-coated tablet contains 750 mg levetiracetam.
Excipient with known effect:
Each film-coated tablet contains 0.156 mg sunset yellow E110.
Levetiracetam Actavis 1000 mg film-coated tablets
Each film-coated tablet contains 1000 mg levetiracetam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Levetiracetam Actavis 250 mg film-coated tablets
Oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and
“250” on the other side.
Levetiracetam Actavis 500 mg film-coated tablets
Oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and
“500” on the other side.
Levetiracetam Actavis 750 mg film-coated tablets
Oval, orange 19.0 x 9.3 mm marked with “L” on one side and
“750” on the other side.
Levetiracetam Actavis 1000 mg film-coated tablets
Oval, white, 19.0 x 10.0 mm marked with “L” on one side and
“1000” on the other side.
4.
CLINICAL PARTICULARS
3
4.1
THERAPEUTIC INDICATIONS
Levetiracetam Actavis 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 Actavis 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