Trelema 10 mg/ml Sirap

Country: Шведска

Језик: Шведски

Извор: Läkemedelsverket (Medical Products Agency)

Активни састојак:

lakosamid

Доступно од:

G.L. Pharma GmbH

АТЦ код:

N03AX18

INN (Међународно име):

lacosamide

Дозирање:

10 mg/ml

Фармацеутски облик:

Sirap

Састав:

sorbitol Hjälpämne; glycerol 85% Hjälpämne; lakosamid 10 mg Aktiv substans; metylparahydroxibensoat Hjälpämne

Тип рецептора:

Receptbelagt

Резиме производа:

Förpacknings: Flaska, 100 ml (med doskopp och doseringsspruta); Flaska, 200 ml (med doskopp och doseringsspruta); Flaska, 300 ml (med doskopp och doseringsspruta); Flaska, 500 ml (med doskopp och doseringsspruta)

Статус ауторизације:

Godkänd

Датум одобрења:

2018-06-20

Информативни летак

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TRELEMA 10 MG/ML SYRUP
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] 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,
including loss of consciousness) in patients with idiopathic
generalised epilepsy (the
type of epilepsy that is thought to have a genetic cause).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [LACOSAMIDE]
DO NOT TAKE [LACOSAMIDE]
-
i

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Trelema 10 mg/ml syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of syrup contains 10 mg lacosamide.
Excipients with known effect:
Each ml of syrup contains 187 mg sorbitol (E 420), 2.27 mg methyl
hydroxybenzoate (E 218),
and 1.35 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup
A slightly viscous clear, colourless to yellow-brown liquid
with the smell and taste of
strawberries.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Lacosamide] 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Lacosamide must be taken twice a day (usually once in the morning and
once in the evening).
Lacosamide may be taken with or without food.
If a dose is missed, the patient should be instructed to take the
missed dose immediately, and
then to take the next dose of lacosamide at the regularly scheduled
time. If the patient notices
the missed dose within 6 hours of the next one, he/she should be
instructed to wait to take the
next dose of lacosamide at the regularly scheduled time. Patients
should not take a double
dose.
_Adolescents and children weighing 50 kg or more, and adults_
The following table summarises the recommended posology for
adolescents and children
weighing
50 kg or more, and for adults. More details are provided in the table
below.
Monotherapy
Adjunctive therapy
Starting dose
100 mg/day or 200 mg/day
100 mg/day
Single loading dose
(if applicable)
200 mg
200 mg
Titration (incremental steps)
50 mg twice a day (100 mg/day)
at weekly intervals
50 mg twice a day (100 mg/day)
at weekly intervals
Maximum recommended dose
up to 600 mg/day
up to 400 mg/day
_Monotherapy_
The recommended starting dose is 50 mg twice a day which should be
increased to an initial
therapeutic dose of 100 mg twice a day af