LACOSACOR lacosamide 150 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lacosamide, Quantity: 150 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

168 tablets, 14 tablets, 56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lacosamide film-coated 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.

Product summary:

Visual Identification: Peach, oval shaped, film coated tablets debossed with "LAC" on one side and "150" on other side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-02-08

Patient Information leaflet

LACOSACOR
1
LACOSACOR
_lacosamide _
_ _
_ _
_ _
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor
or pharmacist.
LACOSACOR film-coated tablets contains the active ingredient
lacosamide. LACOSACOR
work by
controlling brain chemicals which send signals to nerves so that
seizures do not happen.
For more information, see Section 1. Why am I using LACOSACOR? In the
full CMI.
Do not use if you have ever had an allergic reaction to LACOSACOR or
any of the ingredients listed at the end
of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR
PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING
.
For more information, see Section 2. What should I know before I use
LACOSACOR? In the full CMI
.
Some medicines may interfere with LACOSACOR and affect how it works.
A list of these medicines is in section 3. What if I am taking other
medicines? In the full CMI.
Your doctor will tell you how much LACOSACOR you will need to take
each day. This may depend on your
condition, your body weight, and whether or not you are taking any
other medicines.
More instructions can be found in Section 4. How do I use LACOSACOR?
In the full CMI.
THINGS
YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
LACOSACOR.
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist that
you are taking LACOSAMIDE.
•
Stop taking LACOSACOR and contact your doctor immediately if you
become pregnant
while you are taking LACOSACOR.
THINGS
YOU
SHOULD NOT DO
•
Do not give this medicine to anyone else, even if their condition
seems similar to yours.
•
Do not use it to treat any other complaints unless your doctor tells
you to.
DRIVING
OR
USING MACHINES
•
Be careful before you drive or use any machines or tools until you
know how
LACOSACOR affects you.
•
LACOSACOR cause problems with your ability to drive a car or operate
machinery.
DRINKING
ALCOHOL
•
Tell your doctor if

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
LACOSACOR (LACOSAMIDE) TABLETS
1.
NAME OF THE MEDICINE
Lacosamide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
LACOSACOR
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
LACOSACOR film coated tablets 50 mg
Pink, oval shaped, film coated tablets debossed with "LAC" on one side
and "50" on other
side.
LACOSACOR film coated tablets 100 mg
Dark yellow, oval shaped, film coated tablets debossed with "LAC" on
one side and "100" on
other side.
LACOSACOR film coated tablets 150 mg
Peach, oval shaped, film coated tablets debossed with "LAC" on one
side and "150" on other
side.
LACOSACOR film coated tablets 200 mg
Blue, oval shaped, film coated tablets debossed with "LAC" on one side
and "200" on other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LACOSACOR film-coated 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 oral solution and injection are unavailable in this brand
however are available _
_in other brands. Where correct dosing requires lacosamide oral
solution and injection _
_formulations refer to the specific product information for these
formulations for their _
_complete dosage and administration instructions. _
LACOSACOR therapy can be initiated with either oral or IV
administration. The film-coated
tablets may be taken with or without food. The film-coated tablets
must not be divided.
Conversion to or from oral and IV administration can