Levebon 500 mg Filmdragerad tablett

Χώρα: Σουηδία

Γλώσσα: Σουηδικά

Πηγή: Läkemedelsverket (Medical Products Agency)

Δραστική ουσία:

levetiracetam

Διαθέσιμο από:

G.L. Pharma GmbH

Φαρμακολογική κατηγορία (ATC):

N03AX14

INN (Διεθνής Όνομα):

levetiracetam

Δοσολογία:

500 mg

Φαρμακοτεχνική μορφή:

Filmdragerad tablett

Σύνθεση:

levetiracetam 500 mg Aktiv substans

Kατηγορία:

Apotek

Τρόπος διάθεσης:

Receptbelagt

Θεραπευτική περιοχή:

Levetiracetam

Περίληψη προϊόντος:

Förpacknings: Blister, 10 tabletter; Blister, 20 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 60 tabletter; Blister, 90 tabletter; Blister, 100 tabletter; Blister, 120 tabletter; Blister, 200 tabletter; Burk, 10 tabletter; Burk, 20 tabletter; Burk, 30 tabletter; Burk, 50 tabletter; Burk, 60 tabletter; Burk, 90 tabletter; Burk, 100 tabletter; Burk, 120 tabletter; Burk, 200 tabletter

Καθεστώς αδειοδότησης:

Godkänd

Ημερομηνία της άδειας:

2012-02-10

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
250 MG FILM-COATED TABLETS.
500 MG FILM-COATED TABLETS.
750 MG FILM-COATED TABLETS.
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
film-coated tablets are an antiepileptic medicine (a
medicine used to treat seizures
in epilepsy).
is used:

on its own in patients from 16 years of age with newly diagnised
epilepsy, to treat
partial onset seizures with or without secondary generalisation.

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 in patients from 12 years of age with juvenile
myoclonic
epilepsy.

primary generalised tonic-clonic seizures in adults and adolescents
from 12 years of
age with idiopathic generalised epilepsy
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE

if you are allergic to levetiracetam or any of the other ingredients
of this medicine
(listed in Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking
PDF rendering: Titel 00421076, Version 5.4, Namn Levebon fi

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
250 mg film-coated tablets.
500 mg film-coated tablets.
750 mg film-coated tablets.
1000 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ 250 mg film-coated tablets_
Each film-coated tablet contains 250 mg levetiracetam.
_ 500 mg film-coated tablets_
Each film-coated tablet contains 500 mg levetiracetam.
_ 750 mg film-coated tablets_
Each film-coated tablet contains 750 mg levetiracetam.
Excipient: Each film-coated tablet contains 0.17 mg of sunset yellow
FCF (E110).
_ 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.
_ 250 mg film-coated tablets_
Blue coloured, capsule shaped tablets (12,7 x 5,9 mm) with deep notch
on one side.
The
tablets can be divided into equal doses.
_ 500 mg film-coated tablets_
Yellow coloured, capsule shaped tablets (16,3 x 7,6 mm)with deep notch
on one side.
The
tablets can be divided into equal doses.
_ 750 mg film-coated tablets_
Orange coloured, capsule shaped tablets (18,6 x 8,65 mm) with deep
notch on one side.
The tablets can be divided into equal doses.
_ 1000 mg film-coated tablets_
White coloured, capsule shaped tablets (19,1 x 10,2 mm) with deep
notch on one side.
The
tablets can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
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 Epil