Lacosamide G.L. 50 mg + 100 mg + 150 mg + 200 mg Filmdragerad tablett

Država: Švedska

Jezik: švedski

Izvor: Läkemedelsverket (Medical Products Agency)

Aktivni sastojci:

lakosamid

Dostupno od:

G.L. Pharma GmbH

ATC koda:

N03AX18

INN (International ime):

lacosamide

Doziranje:

50 mg + 100 mg + 150 mg + 200 mg

Farmaceutski oblik:

Filmdragerad tablett

Sastav:

lakosamid 200 mg Aktiv substans; lakosamid 150 mg Aktiv substans; lakosamid 100 mg Aktiv substans; lakosamid 50 mg Aktiv substans

Tip recepta:

Receptbelagt

Proizvod sažetak:

Förpacknings: Blister, 14 + 14 + 14 + 14 tabletter

Status autorizacije:

Godkänd

Datum autorizacije:

2018-06-20

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACOSAMIDE G.L. 50 MG FILM-COATED TABLETS
LACOSAMIDE G.L. 100 MG FILM-COATED TABLETS
LACOSAMIDE G.L. 150 MG FILM-COATED TABLETS
LACOSAMIDE G.L. 200 MG FILM-COATED TABLETS
lacosamide
THE TREATMENT INITIATION PACK IS ONLY SUITABLE IN ADOLESCENTS AND
CHILDREN WEIGHING
50 KG OR MORE AND IN ADULTS.
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] is and what it is used for
2.
What you need to know before you take [Lacosamide]
3.
How to take [Lacosamide]
4.
Possible side effects
5.
How to store [Lacosamide]
6.
Contents of the pack and other information
1.
WHAT [LACOSAMIDE] IS AND WHAT IT IS USED FOR
WHAT [LACOSAMIDE] IS
[Lacosamide] 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] IS USED FOR
-
[Lacosamide] is used in, adolescents and children aged 4 years and
older weighing 50 kg
or more and in adults.
-
It is used:
-
on its own and in association with other antiepileptic medicines 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 to treat primary
generalised tonic-
clonic sei

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lacosamide G.L. treatment initiation pack (in adolescent and children
weighing 50 kg or more
and adults only)
Lacosamide G.L. 50 mg film-coated tablets
Lacosamide G.L. 100 mg film-coated tablets
Lacosamide G.L. 150 mg film-coated tablets
Lacosamide G.L. 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_[Lacosamide 50 mg film-coated tablets]_
Each film-coated tablet contains 50 mg lacosamide.
_[Lacosamide 100 mg film-coated tablets]_
Each film-coated tablet contains 100 mg lacosamide.
_[Lacosamide 150 mg film-coated tablets]_
Each film-coated tablet contains 150 mg lacosamide.
_[Lacosamide 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 50 mg film-coated tablets]_
Pink coloured, oval and biconvex f/c tablets, with a break-score on
both sides and with a length
of about 10.3 mm.
The tablet can be divided into equal doses.
_[Lacosamide 100 mg film-coated tablets]_
Yellow coloured, oval and biconvex f/c tablets, with a break-score on
both sides and with a
length of about 13.1 mm.
The tablet can be divided into equal doses.
_[Lacosamide 150 mg film-coated tablets]_
Brown coloured, oval and biconvex f/c tablets, with a break-score on
both sides and with a
length of about 15.1 mm.
The tablet can be divided into equal doses.
_[Lacosamide 200 mg film-coated tablets]_
Blue coloured, oval and biconvex f/c tablets, with a break-score on
both sides and with a length
of about 16.5 mm.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Lacosamide] 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] is indicated as adjunctive therapy
•
in the treatment of partial-onset seizures with or without secondary
generalisation