LACOSAM lacosamide 50 mg film-coated tablets blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

lacosamide, Quantity: 50 mg

から入手可能:

Accord Healthcare Pty Ltd

医薬品形態:

Tablet, film coated

構図:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; hyprolose; colloidal anhydrous silica; crospovidone; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black; lecithin; indigo carmine aluminium lake

投与経路:

Oral

パッケージ内のユニット:

14 tablets

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Lacosam tablets are indicated as: ? monotherapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older. ? add-on therapy in the treatment of primary generalised tonic-clonic seizures in patients with idiopathic generalised epilepsy aged 4 years and older

製品概要:

Visual Identification: Pink, oval, coated tablets, debossed "L" on one side and "50" on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

認証ステータス:

Registered

承認日:

2019-05-29

情報リーフレット

LACOSAM
CONSUMER MEDICINE INFORMATION Version: 1.2
-2018-
Page: 1 of 4
LACOSAM
(LACOSAMIDE FILM-COATED TABLETS 50 MG, 100 MG, 150 MG, 200 MG)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Lacosam.
It
does
not
contain
all
the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All
medicines
have
risks
and
benefits.
Your
doctor
has
weighed the risks of you taking
Lacosam
against
the
benefits
they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK
YOUR
DOCTOR OR PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT LACOSAM IS USED
FOR
Lacosam are used by itself (in
patients over 16 years) or in
combination with other
medicines to control epilepsy.
Epilepsy is a condition where you
have repeated seizures. There
are many different types of
seizures, ranging from mild to
severe.
This medicine belongs to a group
of medicines called
antiepileptics. These medicines
are thought to work by
controlling brain chemicals
which send signals to nerves so
that seizures do not happen.
Your doctor may have prescribed
this medicine for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
There is no evidence that
Lacosam is addictive.
This medicine is available only
with a doctor's prescription.
Lacosam is not recommended
for use in children under the
age of 4 years as its safety and
effectiveness has not been
established in this age group.
BEFORE YOU TAKE
LACOSAM
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE LACOSAM IF YOU
HAVE AN ALLERGY TO
•
ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin
_ _
DO NOT TAKE LACOSAM IF YOU
HAVE, OR HAVE HAD, A HEART
CONDITION CAUSING AN UNEVEN
HEART BEAT.
If you

製品の特徴

1
AUSTRALIAN PRODUCT INFORMATION – LACOSAM (Lacosamide)
1
NAME OF THE MEDICINE
Lacosamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lacosam film-coated tablets are available in strengths of 50 mg, 100
mg, 150 mg and 200 mg
lacosamide.
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Film-coated tablets
50 mg: Pink-coloured, oval, film-coated tablets, debossed “L” on
one side and “50” on other side.
100 mg: Dark yellow-coloured, oval, film-coated tablets, debossed
“L” on one side and “100” on
other side.
150 mg: Salmon-coloured, oval, film-coated tablets, debossed “L”
on one side and “150” on other
side.
200 mg: Blue-coloured, oval, film-coated tablets, debossed “L” on
one side and “200” on other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC
INDICATIONS
Lacosam tablets are indicated as:

monotherapy in the treatment of partial seizures with or without
secondary generalisation in
patients with epilepsy aged 16 years and older.

add-on therapy in the treatment of partial seizures with or without
secondary generalisation in
patients with epilepsy aged 4 years and older.
4.2
DOSE
AND
METHOD
OF
ADMINISTRATION
Lacosamide film-coated tablets may be taken with or without food.
Lacosamide oral solution and solution for injection formulations are
unavailable in this brand
however are available in other brands. Where correct dosing requires
lacosamide oral solution
or solution for injection formulations; other suppliers should be used
and the specific product
information
for
these
formulations
should
be
referred
to
for
the
complete
dosage
and
administration instructions.
In
accordance
with
current
clinical
practice,
if
Lacosam
has
to
be
discontinued,
it
is
recommended this be done gradually (e.g. taper the daily dose by 200
mg/week).
2
The following table summarises the recommended dose for lacosamide.
More details are
provided below.
Monotherapy
Add-on therapy
Adults
Adolescents and
children
Adolescents and
children weighing
50 kg or more, and