Lacosamide Accord

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

lacosamide

Saatavilla:

Accord Healthcare S.L.U.

ATC-koodi:

N03AX18

INN (Kansainvälinen yleisnimi):

lacosamide

Terapeuttinen ryhmä:

Antiepileptics,

Terapeuttinen alue:

Epilepsy

Käyttöaiheet:

Lacosamide Accord is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.Lacosamide Accord is indicated as 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.•         in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Tuoteyhteenveto:

Revision: 12

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2017-09-18

Pakkausseloste

88
B. PACKAGE LEAFLET
89
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACOSAMIDE ACCORD 50 MG FILM-COATED TABLETS
LACOSAMIDE ACCORD 100 MG FILM-COATED TABLETS
LACOSAMIDE ACCORD 150 MG FILM-COATED TABLETS
LACOSAMIDE ACCORD 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 Lacosamide Accord is and what it is used for
2.
What you need to know before you take Lacosamide Accord
3.
How to take Lacosamide Accord
4.
Possible side effects
5.
How to store Lacosamide Accord
6.
Contents of the pack and other information
1.
WHAT LACOSAMIDE ACCORD IS AND WHAT IT IS USED FOR
WHAT LACOSAMIDE ACCORD IS
Lacosamide Accord 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 LACOSAMIDE ACCORD IS USED FOR

Lacosamide Accord is used:
o
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.
o
in association with other antiepileptic medicines in adults,
adolescents and children aged 4
years and older to treat primary generalised tonic- clonic seizures

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lacosamide Accord 50 mg film-coated tablets
Lacosamide Accord 100 mg film-coated tablets
Lacosamide Accord 150 mg film-coated tablets
Lacosamide Accord 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lacosamide Accord 50 mg film-coated tablets
One film-coated tablet contains 50 mg lacosamide.
Lacosamide Accord 100 mg film-coated tablets
One film-coated tablet contains 100 mg lacosamide.
Lacosamide Accord 150 mg film-coated tablets
One film-coated tablet contains 150 mg lacosamide.
Lacosamide Accord 200 mg film-coated tablets
One film-coated tablet contains 200 mg lacosamide.
Excipient(s) with known effect:
50 mg: Each film-coated tablet contains 0.105 mg of lecithin (soya)
100 mg: Each film-coated tablet contains 0.210 mg of lecithin (soya)
150 mg: Each film-coated tablet contains 0.315 mg of lecithin (soya)
200 mg: Each film-coated tablet contains 0.420 mg of lecithin (soya)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Lacosamide Accord 50 mg film-coated tablets
Pink, oval, approximately 10.3 x 4.8 mm, coated tablets, debossed
“L” on one side and “50” on other
side.
Lacosamide Accord 100 mg film-coated tablets
Dark yellow, oval, approximately 13.0 x 6.0 mm, coated tablets,
debossed “L” on one side and “100” on
other side.
Lacosamide Accord 150 mg film-coated tablets
Salmon, oval, approximately 15.0 x 6.9 mm, coated tablets, debossed
“L” on one side and “150” on
other side.
Lacosamide Accord 200 mg film-coated tablets
3
Blue, oval, approximately 16.4 x 7.6 mm, coated tablets, debossed
“L” on one side and “200” on other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lacosamide Accord 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.
Lacosamide Accord is indicated as adjunctive therapy

in th