LACOSAMIDE SANDOZ lacosamide 50 mg film-coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

lacosamide, Quantity: 50 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; crospovidone; hyprolose; 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, 14 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Lacosamide Sandoz (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.,Paediatric patents weighing less than 50 kg should not receive Lacosamide Sandoz film-coated tablets. Paediatric patients weighing less than 50 kg should be accurately dosed on a mg/kg basis with other lacosamide products.

Product summary:

Visual Identification: Pink coloured, oval shaped tablets debossed with I73 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 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-07-06

Patient Information leaflet

Lacosamide Sandoz®
1
LACOSAMIDE SANDOZ®
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 SANDOZ?
Lacosamide Sandoz contains the active ingredient lacosamide.
Lacosamide Sandoz is used in patients over 4 years in
combination with other medicines to control epilepsy. Lacosamide
Sandoz tablets are used by itself (in patients over 16 years)
to control epilepsy.
For more information, see Section 1. Why am I using Lacosamide Sandoz?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LACOSAMIDE SANDOZ?
Do not use Lacosamide Sandoz 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
Lacosamide Sandoz?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Lacosamide Sandoz 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 SANDOZ?
•
Your doctor will tell you how much Lacosamide Sandoz 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.
•
Your doctor may start you on a low dose of Lacosamide Sandoz first of
50 mg or 100 mg twice a day. Your doctor may
slowly increase your dose up to a maximum of 300 mg twice a day, until
you are taking enough to control your epilepsy
and you are not having any seizures.
More instructions can be found in Section 4. How do I use Lacosamide
Sandoz?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LACOSAMIDE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Lacosamide Sandoz.
•
Tell yo

Summary of Product characteristics

211122-lacosamide-sandoz-pi
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION
LACOSAMIDE SANDOZ (LACOSAMIDE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Lacosamide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lacosamide Sandoz 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
50 MG FILM-COATED TABLETS:
Pink coloured, oval shaped tablets debossed with “I73” on one side
and plain on other side.
100 MG FILM-COATED TABLETS:
Dark yellow coloured, oval shaped tablets debossed with “I74” on
one side and plain on other side.
150 MG FILM-COATED TABLETS:
Peach coloured, oval shaped tablets debossed with “I75” on one
side and plain on other side.
200 MG FILM-COATED TABLETS:
Blue coloured, oval shaped tablets debossed with “I76” on one side
and plain on other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC
I
NDICATIONS
Lacosamide Sandoz (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.
Paediatric patents weighing less than 50 kg should not receive
Lacosamide Sandoz film-coated
tablets. Paediatric patients weighing less than 50 kg should be
accurately dosed on a mg/kg basis
with other lacosamide products.
4.2
D
OSE 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 i