Keppra
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
22-03-2023
Charakterystyka produktu
(SPC)
22-03-2023
Sprawozdanie z oceny publicznego
(PAR)
02-06-2021
Składnik aktywny:
levetiracetam
Dostępny od:
UCB Pharma SA
Kod ATC:
N03AX14
INN (International Nazwa):
levetiracetam
Grupa terapeutyczna:
Antiepileptics,
Dziedzina terapeutyczna:
Epilepsy
Wskazania:
Keppra 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.Keppra 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: 53
Status autoryzacji:
Authorised
Data autoryzacji:
2000-09-29
Ulotka dla pacjenta
144
B. PACKAGE LEAFLET
145
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KEPPRA 250 MG FILM-COATED TABLETS
KEPPRA 500 MG FILM-COATED TABLETS
KEPPRA 750 MG FILM-COATED TABLETS
KEPPRA 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 Keppra is and what it is used for
2.
What you need to know before you take Keppra
3.
How to take Keppra
4.
Possible side effects
5.
How to store Keppra
6.
Contents of the pack and other information
1.
WHAT KEPPRA IS AND WHAT IT IS USED FOR
Levetiracetam is an antiepileptic medicine (a medicine used to treat
seizures in epilepsy).
Keppra 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 epilepsy;
▪
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Keppra 250 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 250 mg levetiracetam.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, 13mm oblong, scored and debossed with the code “ucb” and
“250” on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Keppra 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.
Keppra 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.
Depending upon the clinical response and tolerability, the daily dose
can be increased up to 1500 mg
twice daily. Dose changes can be made in 250 mg or 500 mg twice daily
increases or decreases every
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