Anlamyl 10 mg/ml syrup

Χώρα: Μάλτα

Γλώσσα: Αγγλικά

Πηγή: Malta Medicines Authority

Διαθέσιμο από:

Anfarm Hellas S.A. 4 Achaias Str. & Trizinias 14564 Kifissia, Attiki, Greece

Φαρμακολογική κατηγορία (ATC):

N03AX18

INN (Διεθνής Όνομα):

LACOSAMIDE 10 mg/ml

Φαρμακοτεχνική μορφή:

SYRUP

Σύνθεση:

LACOSAMIDE 10 mg/ml

Τρόπος διάθεσης:

POM

Θεραπευτική περιοχή:

ANTIEPILEPTICS

Περίληψη προϊόντος:

Licence number in the source country: NOT APPLICAPABLE

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2023-06-16

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANLAMYL 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 Anlamyl is and what it is used for
2.
What you need to know before you take Anlamyl
3.
How to take Anlamyl
4.
Possible side effects
5.
How to store Anlamyl
6.
Contents of the pack and other information
1.
WHAT ANLAMYL IS AND WHAT IT IS USED FOR
WHAT ANLAMYL IS
Anlamyl 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 ANLAMYL IS USED FOR
Anlamyl 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 ANLAMYL
DO NOT TAKE ANLAMYL
•
if you are allergic to lacosamide, or

Αρχείο Π.Χ.Π.

OGYÉI/34127/2022
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Anlamyl 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 Anlamyl syrup contains 187 mg sorbitol (E420), 2.60 mg
sodium methyl
parahydroxybenzoate (E219), 2.14 mg propylene glycol (E1520), 1.42 mg
sodium and 0.032 mg
aspartame (E951).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup.
A slightly viscous clear, colourless to yellow-brown liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anlamyl 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.
Anlamyl 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
2
2
STARTING DOSE
TITRATION
(INCREMENTAL
STEPS)