LACOSAMIDE Lupin lacosamide 100 mg film-coated tablets blister pack

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

lacosamide, Quantity: 100 mg

Tersedia dari:

Generic Health Pty Ltd

Bentuk farmasi:

Tablet, film coated

Komposisi:

Excipient Ingredients: crospovidone; magnesium stearate; colloidal anhydrous silica; microcrystalline cellulose; hyprolose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; lecithin

Rute administrasi :

Oral

Unit dalam paket:

14 tablets, 56 tablets

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

Lacosamide Lupin tablets are indicated as: ? monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older. ? add-on therapy in the treatment of partial-onset 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.

Ringkasan produk:

Visual Identification: Dark yellow, oval, coated tablets, debossed "L" on one side and "100" 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

Status otorisasi:

Registered

Tanggal Otorisasi:

2019-05-29

Selebaran informasi

CONSUMER MEDICINE INFORMATION
LACOSAMIDE LUPIN
(LACOSAMIDE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Lacosamide Lupin.
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
Lacosamide Lupin 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 LACOSAMIDE LUPIN
IS USED FOR
Lacosamide Lupin is used in
patients over 4 years in
combination with other
medicines to control epilepsy.
Lacosamide Lupin can only be
used by itself in patients over 16
years. 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
Lacosamide Lupin is addictive.
This medicine is available only
with a doctor's prescription.
Lacosamide Lupin 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
LACOSAMIDE LUPIN
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LACOSAMIDE LUPIN
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 LACOSAMIDE LUPIN
IF YOU HAVE, OR HAVE HAD, A
HEAR

Karakteristik produk

AUSTRALIAN PRODUCT INFORMATION – LACOSAMIDE LUPIN
(LACOSAMIDE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Lacosamide.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lacosamide Lupin film-coated tablets contain 50 mg, 100 mg, 150 mg or
200 mg lacosamide.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Lacosamide Lupin 50 mg film-coated tablet: Pink-coloured, oval,
film-coated tablets, debossed “L” on
one side and “50” on other side.
Lacosamide Lupin 100 mg film-coated tablet: Dark yellow-coloured,
oval, film-coated tablets, debossed
“L” on one side and “100” on other side.
Lacosamide Lupin 150 mg film-coated tablet: Salmon-coloured, oval,
film-coated tablets, debossed “L”
on one side and “150” on other side.
Lacosamide Lupin 200 mg film-coated tablet: Blue-coloured, oval,
film-coated tablets, debossed “L” on
one side and “200” on other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lacosamide Lupin tablets are indicated as:
•
monotherapy in the treatment of partial-onset seizures with or without
secondary generalisation
in patients with epilepsy aged 16 years and older.
•
add-on therapy in the treatment of partial-onset 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.
4.2 DOSE AND METHOD OF ADMINISTRATION
Lacosamide Lupin 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.
Lacosamide Lupin v2.0
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