Lacosamide Neuraxapharm 10 mg/ml syrup

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lacosamide

Available from:

Neuraxpharm Ireland Limited

ATC code:

N03AX18

INN (International Name):

Lacosamide

Dosage:

10 milligram(s)/millilitre

Pharmaceutical form:

Syrup

Therapeutic area:

lacosamide

Authorization status:

Not marketed

Authorization date:

2021-10-29

Patient Information leaflet

Lacosamide Neuraxpharm 10mg/ml Syrup
Package Leaflet
IE-Version 2021/12
Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LACOSAMIDE NEURAXPHARM 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 Neuraxpharm is and what it is used for
2.
What you need to know before you take Lacosamide Neuraxpharm
3.
How to take Lacosamide Neuraxpharm
4.
Possible side effects
5.
How to store Lacosamide Neuraxpharm
6.
Contents of the pack and other information
1.
WHAT
LACOSAMIDE NEURAXPHARM
IS AND WHAT IT IS USED FOR
WHAT LACOSAMIDE NEURAXPHARM
IS
Lacosamide Neuraxpharm 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 NEURAXPHARM
IS USED FOR
•
Lacosamide Neuraxpharm is used in adults, adolescents and children
aged 4 years and older.
•
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
seizures (major fits, including loss of consciousness) in patients
with idiopathic generalised
e

Summary of Product characteristics

Health Products Regulatory Authority
21 July 2022
CRN00D12T
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lacosamide Neuraxapharm 10 mg/ml syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml syrup contains 10 mg lacosamide.
One bottle of 200 ml contains 2,000 mg lacosamide.
Excipients with known effect
Each ml syrup contains 280 mg sorbitol (E 420), 40.55 mg propylene
glycol (E 1520), 4.43 mg to 4.64 mg sodium, 1.29 mg
sodium methyl para-hydroxybenzoate (E 219) and 0.4 mg aspartame (E
951).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup.
Slightly viscous clear, colourless liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lacosamide Neuraxapharm is indicated as monotherapy in the treatment
of partial-onset seizures with or without secondary
generalisation in adults, adolescents and children from 4 years of age
with epilepsy.
Lacosamide Neuraxapharm is indicated as 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.
- 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
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. M