LACORESS lacosamide 100 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lacosamide, Quantity: 100 mg

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; colloidal anhydrous silica; hyprolose; crospovidone; microcrystalline cellulose; titanium dioxide; hypromellose; purified talc; iron oxide yellow; macrogol 6000; macrogol 400

Administration route:

Oral

Units in package:

56, 14

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lacoress (lacosamide) 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: Dark yellow, oval, film-coated tablets debossed with "L424" on one side and plain on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-05-11

Patient Information leaflet

LACORESS
1
LACORESS
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 LACORESS?
LACORESS contains the active ingredient Lacosamide. LACORESS is used
in patients over 4 years in combination with other
medicines to control epilepsy and monotherapy in the treatment of
partial-onset seizures with or without secondary
generalisation in patients with epilepsy aged 16 years and older.
For more information, see Section 1. Why am I using LACORESS? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LACORESS?
Do not use if you have ever had an allergic reaction to Lacosamide 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
LACORESS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with LACORESS 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 LACORESS?
•
The dose of LACORESS may depend on your condition, your body weight,
and whether or not you are taking any other
medicines. Your doctor will tell you how much LACORESS you will need
to take each day.
•
Swallow LACORESS tablets whole with a glass of water.
More instructions can be found in Section 4. How do I use LACORESS? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LACORESS?
THINGS YOU
SHOULD DO
• Remind any doctor, dentist or pharmacist you visit that you are
using LACORESS.
• Tell your doctor immediately if you notice an increase in
seizures, if you have symptoms of depression
or thoughts of harming yourself or if you feel LACORESS is not helping
your condition.
THINGS YOU
SHOULD NOT DO
• Do not stop using this medicine suddenly or change the dosage
unless your docto

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
LACORESS (LACOSAMIDE) FILM-COATED TABLETS
1.
NAME OF THE MEDICINE
Lacosamide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
LACORESS 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, oval debossed with ‘423’ on one side and plain on the
other side.
100 mg: Dark yellow, oval debossed with ‘L424’ on one side and
plain on the other side.
150 mg: Salmon, oval debossed with ‘L425’ on one side and plain on
the other side.
200 mg: Blue, oval debossed with ‘L426’ on one side and plain on
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LACORESS (lacosamide) 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. _
LACORESS 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.
2
Conversion to or from oral and IV administration can be done directly
without titration. The total daily
dose and twice daily administration should be maintained.
In accordance with current clinical practice, if LACORESS has to be