Matever
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
29-06-2023
Charakterystyka produktu
(SPC)
29-06-2023
Sprawozdanie z oceny publicznego
(PAR)
14-10-2011
Składnik aktywny:
levetiracetam
Dostępny od:
Pharmathen S.A.
Kod ATC:
N03AX14
INN (International Nazwa):
levetiracetam
Grupa terapeutyczna:
Antiepileptics,
Dziedzina terapeutyczna:
Epilepsy
Wskazania:
Matever 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.Matever 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.
Podsumowanie produktu:
Revision: 27
Status autoryzacji:
Authorised
Data autoryzacji:
2011-10-03
Ulotka dla pacjenta
65
B. PACKAGE LEAFLET
66
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MATEVER 250 MG FILM-COATED TABLETS
MATEVER 500 MG FILM-COATED TABLETS
MATEVER 750 MG FILM-COATED TABLETS
MATEVER 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 Matever is and what it is used for
2.
What you need to know before you take Matever
3.
How to take Matever
4.
Possible side effects
5.
How to store Matever
6.
Contents of the pack and other information
1.
WHAT MATEVER IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Matever 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 juvenile myoclonic epile
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Matever 250 mg film-coated tablets
Matever 500 mg film-coated tablets
Matever 750 mg film-coated tablets
Matever 1000 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Matever 250 mg film-coated tablets
Each film-coated tablet contains 250 mg levetiracetam.
Excipients with known effect
Each film-coated tablet contains 0.0025 mg sunset yellow FCF aluminum
lake (E110).
_ _
Matever 500 mg film-coated tablets
Each film-coated tablet contains 500 mg levetiracetam.
Matever 750 mg film-coated tablets
Each film-coated tablet contains 750 mg levetiracetam.
Excipients with known effect
Each film-coated tablet contains 0.08 mg sunset yellow FCF aluminum
lake (E110).
_ _
Matever 1000 mg film-coated tablets
Each film-coated tablet contains 1000 mg levetiracetam.
Excipients with known effect
Each film-coated tablet contains 3.8 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Matever 250 mg film-coated tablets
Blue, oblong, biconvex film-coated tablets.
_ _
Matever 500 mg film-coated tablets
Yellow, oblong, biconvex film-coated tablets.
_ _
Matever 750 mg film-coated tablets
Pink, oblong, biconvex film-coated tablets.
3
_ _
Matever 1000 mg film-coated tablets
White, oblong, biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Matever 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.
Matever 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 adolescen
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