Lacosamide Krka 150 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lacosamide

Available from:

KRKA, d.d., Novo mesto

ATC code:

N03AX18

INN (International Name):

Lacosamide

Dosage:

150 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

lacosamide

Authorization status:

Marketed

Authorization date:

2020-09-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACOSAMIDE KRKA 50 MG FILM-COATED TABLETS
LACOSAMIDE KRKA 100 MG FILM-COATED TABLETS
LACOSAMIDE KRKA 150 MG FILM-COATED TABLETS
LACOSAMIDE KRKA 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 Krka is and what it is used for
2.
What you need to know before you take Lacosamide Krka
3.
How to take Lacosamide Krka
4.
Possible side effects
5.
How to store Lacosamide Krka
6.
Contents of the pack and other information
1.
WHAT LACOSAMIDE KRKA IS AND WHAT IT IS USED FOR
WHAT LACOSAMIDE KRKA IS
Lacosamide Krka 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 KRKA IS USED FOR
-
It 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
g

Summary of Product characteristics

Health Products Regulatory Authority
02 January 2024
CRN00DWTP
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lacosamide Krka 150 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg lacosamide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Pale brownish orange, oval, biconvex, film-coated tablets engraved
with 150 on one side, tablet dimension: approx. 15 x 7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lacosamide Krka 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 Krka 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
DOSE
MONOTHERAPY: 50 mg twice a day (100 mg/day) or 100 mg twice a