LACOSAMIDE ARX 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:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

56 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lacosamide ARX 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: Blue, oval, coated tablets, debossed "L" on one side and "200" on other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-05-29

Patient Information leaflet

LACOSAMIDE ARX
1
LACOSAMIDE ARX
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LACOSAMIDE ARX?
LACOSAMIDE ARX contains the active ingredient lacosamide. LACOSAMIDE
ARX is used by itself (in patients over 16 years) or in
combination with other medicines to control epilepsy.
For more information, see Section 1. Why am I using LACOSAMIDE ARX? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LACOSAMIDE ARX?
Do not use if you have ever had an allergic reaction to LACOSAMIDE ARX
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
LACOSAMIDE ARX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LACOSAMIDE ARX 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.
4.
HOW DO I USE LACOSAMIDE ARX?
•
Swallow LACOSAMIDE ARX tablets whole with a glass of water.
More instructions can be found in Section 4. How do I use LACOSAMIDE
ARX? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LACOSAMIDE ARX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
LACOSAMIDE ARX.
•
If you are pregnant or become pregnant while taking LACOSAMIDE ARX.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not take LACOSAMIDE ARX to treat any other complaints unless your
doctor tells you to.
•
Do not drink alcohol before or after taking this medicine.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how this
medicine affects you.
DRINKING
ALCOHOL
•
Do not drink alcohol before or after taking this medicine.
LOOKING AFTER
YOUR MEDICINE
•
Keep your tablets in t

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – LACOSAMIDE ARX (LACOSAMIDE)
1
NAME OF THE MEDICINE
Lacosamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lacosamide ARX 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
Lacosamide ARX 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 Lacosamide ARX 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