Levetiracetam Actavis Group

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 Group 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 Group 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.

Περίληψη προϊόντος:

Revision: 18

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2011-12-04

Φύλλο οδηγιών χρήσης

36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM ACTAVIS GROUP 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.
-
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 Group is and what it is used for
2.
What you need to know before you take Levetiracetam Actavis Group
3.
How to take Levetiracetam Actavis Group
4.
Possible side effects
5.
How to store Levetiracetam Actavis Group
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM ACTAVIS GROUP IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam Actavis Group 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

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1
.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam Actavis Group 100 mg/ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 100 mg levetiracetam.
Excipients with known effect:
Each ml contains 1.50 mg of methyl parahydroxybenzoate (E218), 0.15 mg
of propyl
parahydroxybenzoate (E216), 290 mg of maltitol liquid (E965), 3,26 mg
propylene glycol (E 1520)
and 0.25 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Clear, faint yellowish-brown solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam Actavis Group 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 Group 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
_Partial onset seizures _
The recommended dosing for monotherapy (from 16 years of age) and
adjunctive therapy is the same;
as outlined below.
_ _
_All indications _
_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. However, a lower initial dose of 250 mg twice daily may be
given based on physician
assessment of seizure reduction versus potential side effects. This
can be increased to 500 mg twice
daily after two weeks.
3
Depending upon the clinical response and tolerability, the daily dose
can be inc