Vimpat
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
08-01-2024
Charakterystyka produktu
(SPC)
08-01-2024
Sprawozdanie z oceny publicznego
(PAR)
25-03-2024
Składnik aktywny:
lacosamide
Dostępny od:
UCB Pharma SA
Kod ATC:
N03AX18
INN (International Nazwa):
lacosamide
Grupa terapeutyczna:
Antiepileptics,
Dziedzina terapeutyczna:
Epilepsy
Wskazania:
Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Podsumowanie produktu:
Revision: 46
Status autoryzacji:
Authorised
Data autoryzacji:
2008-08-29
Ulotka dla pacjenta
134
B. PACKAGE LEAFLET
135
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIMPAT 50 MG FILM-COATED TABLETS
VIMPAT 100 MG FILM-COATED TABLETS
VIMPAT 150 MG FILM-COATED TABLETS
VIMPAT 200 MG FILM-COATED TABLETS
lacosamide
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 Vimpat is and what it is used for
2.
What you need to know before you take Vimpat
3.
How to take Vimpat
4.
Possible side effects
5.
How to store Vimpat
6.
Contents of the pack and other information
1.
WHAT VIMPAT IS AND WHAT IT IS USED FOR
WHAT VIMPAT IS
Vimpat contains lacosamide. This belongs to a group of medicines
called “antiepileptic medicines”.
These medicines are used to treat epilepsy.
•
You have been given this medicine to lower the number of fits
(seizures) you have.
WHAT VIMPAT IS USED FOR
•
Vimpat is used:
▪
on its own and in association with other antiepileptic medicines in
adults, adolescents
and children aged 2 years and older to treat a certain type of
epilepsy characterised by
the occurrence of partial-onset seizure with or without secondary
generalisation. In this
type of epilepsy, fits first affect only one side of your brain.
However, these may then
spread to larger areas on both sides of your brain;
▪
in association with other antiepileptic medicines in adults,
adolescents and children
aged 4 years and older to treat primary generalised tonic-clonic
seizures (major fits,
including loss of consciousness) in patients with idiopathic
generalised epilepsy (the
type of epilepsy that is thought to h
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vimpat 50 mg film-coated tablets
Vimpat 100 mg film-coated tablets
Vimpat 150 mg film-coated tablets
Vimpat 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vimpat 50 mg film-coated tablets
Each film-coated tablet contains 50 mg lacosamide.
Vimpat 100 mg film-coated tablets
Each film-coated tablet contains 100 mg lacosamide.
Vimpat 150 mg film-coated tablets
Each film-coated tablet contains 150 mg lacosamide.
Vimpat 200 mg film-coated tablets
Each film-coated tablet contains 200 mg lacosamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Vimpat 50 mg film-coated tablets
Pinkish, oval film-coated tablets with approximate dimensions of 10.4
mm x 4.9 mm, and debossed
with ‘SP’ on one side and ‘50’ on the other side.
Vimpat 100 mg film-coated tablets
Dark yellow, oval film-coated tablets with approximate dimensions of
13.2 mm x 6.1 mm, and
debossed with ‘SP’ on one side and ‘100’ on the other side.
Vimpat 150 mg film-coated tablets
Salmon, oval film-coated tablets with approximate dimensions of 15.1
mm x 7.0 mm, and debossed
with ‘SP’ on one side and ‘150’ on the other side.
Vimpat 200 mg film-coated tablets
Blue, oval film-coated tablets with approximate dimensions of 16.6 mm
x 7.8 mm, and debossed with
‘SP’ on one side and ‘200’ on the other side.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vimpat is indicated as monotherapy in the treatment of partial-onset
seizures with or without
secondary generalisation in adults, adolescents and children from 2
years of age with epilepsy.
Vimpat is indicated as adjunctive therapy
•
in the treatment of partial-onset seizures with or without secondary
generalisation in adults,
adolescents and children from 2 years of age with epilepsy.
•
in the treatment of primary generalised tonic-clonic seizures in
adults, adolescents and
children from 4 years of age with idiopathic generalised epilep
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