Trelema 50 mg + 100 mg + 150 mg + 200 mg Filmdragerad tablett

Country: Շվեդիա

language: շվեդերեն

source: Läkemedelsverket (Medical Products Agency)

active_ingredient:

lakosamid

MAH:

G.L. Pharma GmbH

ATC_code:

N03AX18

INN:

lacosamide

dosage:

50 mg + 100 mg + 150 mg + 200 mg

pharmaceutical_form:

Filmdragerad tablett

composition:

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

prescription_type:

Receptbelagt

leaflet_short:

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

authorization_status:

Godkänd

authorization_date:

2018-06-20

PIL

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRELEMA 50 MG FILM-COATED TABLETS
TRELEMA 100 MG FILM-COATED TABLETS
TRELEMA 150 MG FILM-COATED TABLETS
TRELEMA 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:
-
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,

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trelema treatment initiation pack (in adolescent and children weighing
50 kg or more and adults
only)
Trelema 50 mg film-coated tablets
Trelema 100 mg film-coated tablets
Trelema 150 mg film-coated tablets
Trelema 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 in
adults, adolescents and children fro