Lacosamide UCB

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

lacosamide

Saatavilla:

UCB Pharma S.A.

ATC-koodi:

N03AX18

INN (Kansainvälinen yleisnimi):

lacosamide

Terapeuttinen ryhmä:

Antiepileptics,

Terapeuttinen alue:

Epilepsies, Partial

Käyttöaiheet:

Lacosamide UCB 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.,

Tuoteyhteenveto:

Revision: 6

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2019-08-26

Pakkausseloste

121
B. PACKAGE LEAFLET
122
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACOSAMIDE UCB 50 MG FILM-COATED TABLETS
LACOSAMIDE UCB 100 MG FILM-COATED TABLETS
LACOSAMIDE UCB 150 MG FILM-COATED TABLETS
LACOSAMIDE UCB 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 UCB is and what it is used for
2.
What you need to know before you take Lacosamide UCB
3.
How to take Lacosamide UCB
4.
Possible side effects
5.
How to store Lacosamide UCB
6.
Contents of the pack and other information
1.
WHAT LACOSAMIDE UCB IS AND WHAT IT IS USED FOR
WHAT LACOSAMIDE UCB IS
Lacosamide UCB 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 UCB IS USED FOR
•
Lacosamide UCB 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 year and older to treat primary generalised tonic-clonic
seizures (major fits,
including loss of con

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lacosamide UCB 50 mg film-coated tablets
Lacosamide UCB 100 mg film-coated tablets
Lacosamide UCB 150 mg film-coated tablets
Lacosamide UCB 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lacosamide UCB 50 mg film-coated tablets
Each film-coated tablet contains 50 mg lacosamide.
Lacosamide UCB 100 mg film-coated tablets
Each film-coated tablet contains 100 mg lacosamide.
Lacosamide UCB 150 mg film-coated tablets
Each film-coated tablet contains 150 mg lacosamide.
Lacosamide UCB 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
Lacosamide UCB 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.
Lacosamide UCB 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.
Lacosamide UCB 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.
Lacosamide UCB 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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lacosamide UCB 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 UCB is indicated as adjunctive therapy
3
•
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