Levetiracetam Accord
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
21-06-2023
Valmisteyhteenveto
(SPC)
21-06-2023
Julkisesta arviointikertomuksesta
(PAR)
10-09-2021
Aktiivinen ainesosa:
levetiracetam
Saatavilla:
Accord Healthcare S.L.U.
ATC-koodi:
N03AX14
INN (Kansainvälinen yleisnimi):
levetiracetam
Terapeuttinen ryhmä:
Antiepileptics,
Terapeuttinen alue:
Epilepsy
Käyttöaiheet:
Levetiracetam 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 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.
Tuoteyhteenveto:
Revision: 16
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2011-10-03
Pakkausseloste
36
B. PACKAGE LEAFLET
37
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEVETIRACETAM ACCORD 250 MG FILM-COATED TABLETS
LEVETIRACETAM ACCORD 500 MG FILM-COATED TABLETS
LEVETIRACETAM ACCORD 750 MG FILM-COATED TABLETS
LEVETIRACETAM ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Levetiracetam Accord
3.
How to take Levetiracetam Accord
4.
Possible side effects
5.
How to store Levetiracetam Accord
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM ACCORD IS AND WHAT IT IS USED FOR
Levetiracetam Accord is an antiepileptic medicine (a medicine used to
treat seizures in epilepsy).
Levetiracetam Accord 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, s
Lue koko asiakirja
Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam Accord 250 mg film-coated tablets
Levetiracetam Accord 500 mg film-coated tablets
Levetiracetam Accord 750 mg film-coated tablets
Levetiracetam Accord 1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam Accord 250 mg film-coated tablets
Each film-coated tablet contains 250 mg levetiracetam
Levetiracetam Accord 500 mg film-coated tablets
Each film-coated tablet contains 500 mg levetiracetam
Levetiracetam Accord 750 mg film-coated tablets
Each film-coated tablet contains 750 mg levetiracetam
Excipient with known effect:
Each film-coated tablet contains 0.013 mg of sunset yellow FCF (E110)
Levetiracetam Accord 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.
The tablet can be divided into equal halves
Levetiracetam Accord 250 mg film-coated tablets
White to off white, oval, biconvex, debossed ‘L 64’ and break line
on one side and plain on the other
side
Levetiracetam Accord 500 mg film-coated tablets
Yellow coloured, oval, biconvex, debossed ‘L 65’ and break line on
one side and plain on the other
side.
Levetiracetam Accord 750 mg film-coated tablets
Pink coloured, oval, biconvex, debossed ‘L 66’ and break line on
one side and plain on the other side.
Levetiracetam Accord 1000 mg film-coated tablets
White to off white, oval, biconvex, debossed ‘L 67’ and break line
on one side and plain on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam 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.
3
Levetiracetam 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
Lue koko asiakirja
