VIMPAT lacosamide 200 mg film-coated tablets blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lacosamide, Quantity: 200 mg

Available from:

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

INN (International Name):

Lacosamide

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

168 tablets, 14 tablets, 56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Vimpat (lacosamide) tablets and oral solution 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.

Product summary:

Visual Identification: Blue, oval tablet debossed with 'SP' on one side and '200' on the other; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2012-07-31

Patient Information leaflet

_ _
1
VIMPAT

_ _tablets & oral solution (pronounced "vim-PAT")
_Contains the active ingredient lacosamide (pronounced
"la-KOE-sa-mide")_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vimpat.
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 Vimpat
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 VIMPAT IS USED
FOR
Vimpat tablets and oral solution are
used in patients over 4 years in
combination with other medicines
to control epilepsy. Vimpat tablets
and oral solution 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 Vimpat is
addictive.
This medicine is available only with
a doctor’s prescription.
Vimpat 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 VIMPAT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VIMPAT IF YOU HAVE
AN ALLERGY TO:
•
Lacosamide or 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
s

Summary of Product characteristics

Vimpat Tablets PI
1
AUSTRALIAN PRODUCT INFORMATION
VIMPAT (LACOSAMIDE) FILM-COATED TABLETS AND ORAL
SOLUTION
1
NAME OF THE MEDICINE
Lacosamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vimpat film-coated tablets are available in strengths of 50 mg, 100
mg, 150 mg and 200 mg
lacosamide. Vimpat oral solution is available as 10 mg/mL strength.
Vimpat oral solution contains the following excipients: sorbitol and
hydroxybenzoates. For the full
list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Film-coated tablets
50 mg: Pinkish, oval debossed with ‘SP’ on one side and ‘50’
on the other side.
100 mg: Dark yellow, oval debossed with ‘SP’ on one side and
‘100’ on the other side.
150 mg: Salmon, oval debossed with ‘SP’ on one side and ‘150’
on the other side.
200 mg: Blue, oval debossed with ‘SP’ on one side and ‘200’ on
the other side.
Oral Solution
Colourless to yellow or yellow brown liquid.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vimpat (lacosamide) tablets and oral solution 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
Vimpat therapy can be initiated with either oral or IV administration.
The oral solution may be diluted
in a glass of water. Both the film-coated tablets and oral solution
may be taken with or without food.
Vimpat Tablets PI
2
The film-coated tablets must not be divided.
A nasogastric tube or gastrostomy tube may be used when administering
the oral solution. The
nasogastric tube or gastrostomy tube should be flushed (twice the
volume of dead space) after the
product deliver