LACOVIM lacosamide 50 mg tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lacosamide, Quantity: 50 mg

Available from:

Pharmacor Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

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: Pink, oval shaped, film coated tablets debossed with "LAC" on one side and "50" on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2022-02-08

Patient Information leaflet

LACOVIM
1
LACOVIM
_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
.
LACOVIM film-coated tablets contains the active ingredient lacosamide.
LACOVIM
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 LACOVIM? In the
full CMI.
Do not use if you have ever had an allergic reaction to LACOVIM 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
LACOVIM? In the full CMI
.
Some medicines may interfere with LACOVIM 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 LACOVIM 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 LACOVIM? In
the full CMI.
THINGS
YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
LACOVIM.
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist that
you are taking LACOSAMIDE.
•
Stop taking LACOVIM and contact your doctor immediately if you become
pregnant while
you are taking LACOVIM.
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 LACOVIM
affects you.
•
LACOVIM cause problems with your ability to drive a car or operate
machinery.
DRINKING
ALCOHOL
•
Tell your doctor if you drink alcohol.
LOOKING
AF

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
LACOVIM (LACOSAMIDE) TABLETS
1.
NAME OF THE MEDICINE
Lacosamide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
LACOVIM
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
LACOVIM film coated tablets 50 mg
Pink, oval shaped, film coated tablets debossed with "LAC" on one side
and "50" on other
side.
LACOVIM film coated tablets 100 mg
Dark yellow, oval shaped, film coated tablets debossed with "LAC" on
one side and "100" on
other side.
LACOVIM film coated tablets 150 mg
Peach, oval shaped, film coated tablets debossed with "LAC" on one
side and "150" on other
side.
LACOVIM 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
LACOVIM 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. _
LACOVIM 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 be done directl