Lacosamide Medical Valley 10 mg/ml Sirap

Ülke: İsveç

Dil: İsveççe

Kaynak: Läkemedelsverket (Medical Products Agency)

Aktif bileşen:

lakosamid

Mevcut itibaren:

Medical Valley Invest AB

ATC kodu:

N03AX18

INN (International Adı):

lacosamide

Doz:

10 mg/ml

Farmasötik formu:

Sirap

Kompozisyon:

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

Reçete türü:

Receptbelagt

Ürün özeti:

Förpacknings: Flaska, 200 ml (med doskopp och doseringsspruta)

Yetkilendirme durumu:

Godkänd

Yetkilendirme tarihi:

2020-04-02

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
[LACOSAMIDE MEDICAL VALLEY] 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 [invented name] is and what it is used for
2.
What you need to know before you take [invented name]
3.
How to take [invented name]
4.
Possible side effects
5.
How to store [invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
WHAT [INVENTED NAME] IS
[invented name] 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 [INVENTED NAME] IS USED FOR
-
[invented name] 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
(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

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
[Lacosamide Medical Valley] 10 mg/ml syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of syrup contains 10 mg lacosamide.
1 bottle of 200 ml contains 2,000 mg lacosamide.
Excipients with known effect:
Each ml of syrup contains 187 mg sorbitol (E 420), 2.27 mg methyl
parahydroxybenzoate (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
[invented name] 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.
[invented name] is indicated as adjunctive therapy
• 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 tonic-clonic seizures in
adults, adolescents and children from
4 years of age with idiopathic generalised epilepsy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The physician should prescribe the most appropriate formulation and
strength according to weight and
dose.
The recommended posology for adults, adolescents and children from 2
years of age is summarised in
the following table.
Lacosamide must be taken twice a day, approximately 12 hours apart
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
STARTING DOSE
TITRATION
(INCREMENTAL
STEPS)
MAXIMUM RECOMMENDED