PHARMACOR LACOSAMIDE lacosamide 100 mg tablet blister pack

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

lacosamide, Quantity: 100 mg

Tilgængelig fra:

Pharmacor Pty Ltd

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

168 tablets, 14 tablets, 56 tablets

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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.

Produkt oversigt:

Visual Identification: Dark yellow, oval shaped, film coated tablets debossed with "LAC" on one side and "100" 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

Autorisation status:

Registered

Autorisation dato:

2022-02-08

Indlægsseddel

PHARMACOR LACOSAMIDE
1
PHARMACOR LACOSAMIDE
_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
.
PHARMACOR LACOSAMIDE film-coated tablets contains the active
ingredient lacosamide. PHARMACOR
LACOSAMIDE
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 PHARMACOR
LACOSAMIDE? In the full CMI.
Do not use if you have ever had an allergic reaction to PHARMACOR
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
PHARMACOR LACOSAMIDE? In the
full CMI
.
Some medicines may interfere with PHARMACOR LACOSAMIDE 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 PHARMACOR LACOSAMIDE 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 PHARMACOR
LACOSAMIDE? In the full CMI.
THINGS
YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
PHARMACOR
LACOSAMIDE.
•
If you are about to be started on any new medicine, remind your doctor
and pharmacist that
you are taking LACOSAMIDE.
•
Stop taking PHARMACOR LACOSAMIDE and contact your doctor immediately
if you
become pregnant while you are taking PHARMACOR LACOSAMIDE.
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
PHARM

Produktets egenskaber

AUSTRALIAN PRODUCT INFORMATION
PHARMACOR LACOSAMIDE (LACOSAMIDE) TABLETS
1.
NAME OF THE MEDICINE
Lacosamide
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PHARMACOR LACOSAMIDE 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
PHARMACOR LACOSAMIDE film coated tablets 50 mg
Pink, oval shaped, film coated tablets debossed with "LAC" on one side
and "50" on other
side.
PHARMACOR LACOSAMIDE film coated tablets 100 mg
Dark yellow, oval shaped, film coated tablets debossed with "LAC" on
one side and "100" on
other side.
PHARMACOR LACOSAMIDE film coated tablets 150 mg
Peach, oval shaped, film coated tablets debossed with "LAC" on one
side and "150" on other
side.
PHARMACOR LACOSAMIDE 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
PHARMACOR 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.
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. _
PHARMACOR LACOSAMIDE therapy can be initiated with either oral or IV
administration.
The film-coated tablets may be taken with or without food. The
film-