Levetiracetam ratiopharm
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
26-06-2023
Charakterystyka produktu
(SPC)
26-06-2023
Sprawozdanie z oceny publicznego
(PAR)
03-09-2021
Składnik aktywny:
levetiracetam
Dostępny od:
ratiopharm GmbH
Kod ATC:
N03AX14
INN (International Nazwa):
levetiracetam
Grupa terapeutyczna:
Antiepileptics,
Dziedzina terapeutyczna:
Epilepsy
Wskazania:
Levetiracetam ratiopharm 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 ratiopharm 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.
Podsumowanie produktu:
Revision: 15
Status autoryzacji:
Authorised
Data autoryzacji:
2011-08-26
Ulotka dla pacjenta
85
B. PACKAGE LEAFLET
86
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
_ _
LEVETIRACETAM RATIOPHARM 250 MG FILM-COATED TABLETS
LEVETIRACETAM RATIOPHARM 500 MG FILM-COATED TABLETS
LEVETIRACETAM RATIOPHARM 750 MG FILM-COATED TABLETS
LEVETIRACETAM RATIOPHARM 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 ratiopharm is and what it is used for
2.
What you need to know before you take Levetiracetam ratiopharm
3.
How to take Levetiracetam ratiopharm
4.
Possible side effects
5.
How to store Levetiracetam ratiopharm
6.
Contents of the pack and other information
1.
WHAT LEVETIRACETAM RATIOPHARM IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Levetiracetam ratiopharm 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 mon
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Levetiracetam ratiopharm 250 mg film-coated tablets
Levetiracetam ratiopharm 500 mg film-coated tablets
Levetiracetam ratiopharm 750 mg film-coated tablets
Levetiracetam ratiopharm 1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam ratiopharm 250 mg film-coated tablets
Each film-coated tablet contains 250 mg levetiracetam.
Levetiracetam ratiopharm 500 mg film-coated tablets
Each film-coated tablet contains 500 mg levetiracetam.
Levetiracetam ratiopharm 750 mg film-coated tablets
Each film-coated tablet contains 750 mg levetiracetam.
Levetiracetam ratiopharm 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 ratiopharm 250 mg film-coated tablets
The 250 mg film-coated tablets are blue, oblong and scored on one
side.
Levetiracetam ratiopharm 500 mg film-coated tablets
The 500 mg film-coated tablets are yellow, oval and scored on one
side.
Levetiracetam ratiopharm 750 mg film-coated tablets
The 750 mg film-coated tablets are light red, oblong and scored on
both sides.
Levetiracetam ratiopharm 1000 mg film-coated tablets
The 1000 mg film-coated tablets are white, oblong and scored on both
sides.
The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam ratiopharm 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 ratiopharm 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.
3
•
in t
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