Kanilad 200 mg film-coated tablets

Country: Malta

Bahasa: Inggeris

Sumber: Malta Medicines Authority

Bahan aktif:

LACOSAMIDE

Boleh didapati daripada:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

Kod ATC:

N03AX18

INN (Nama Antarabangsa):

LACOSAMIDE 200 mg

Borang farmaseutikal:

FILM-COATED TABLET

Komposisi:

LACOSAMIDE 200 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

ANTIEPILEPTICS

Status kebenaran:

Authorised

Tarikh kebenaran:

2018-03-06

Risalah maklumat

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

Ciri produk

Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Kanilad 50 mg film-coated tablets
Kanilad 100 mg film-coated tablets
Kanilad 150 mg film-coated tablets
Kanilad 200 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Kanilad 50 mg film-coated tablets
Each film-coated tablet contains 50 mg lacosamide.
Kanilad 100 mg film-coated tablets
Each film-coated tablet contains 100 mg lacosamide.
Kanilad 150 mg film-coated tablets
Each film-coated tablet contains 150 mg lacosamide.
Kanilad 200 mg film-coated tablets
Each film-coated tablet contains 200 mg lacosamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Kanilad 50 mg film-coated tablets
Pink coloured, oval shaped tablets debossed with “I73” on one side
and plain on the other side.
The average size of the tablets is 10.4 x 4.9 mm.
Page 2 of 27
Kanilad 100 mg film-coated tablets
Dark yellow coloured, oval shaped tablets debossed with “I74” on
one side and plain on the
other side.
The average size of the tablets is 13.0 x 6.0 mm.
Kanilad 150 mg film-coated tablets
Peach coloured, oval shaped tablets debossed with “I75” on one
side and plain on the other side.
The average size of the tablets is 15.0 x 7.0 mm.
Kanilad 200 mg film-coated tablets
Blue coloured, oval shaped tablets debossed with “I76” on one side
and plain on the other side.
The average size of the tablets is 16.5 x 7.7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kanilad is indicated as monotherapy in the treatment of partial-onset
seizures with or without
secondary generalisation in adult, adolescent and children from 2
years of age with epilepsy.
Kanilad 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 generali