Consumer medicine information

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.

5. What should I know while using Lacosamide Sandoz?

6. Are there any side effects?

Common side effects: dizziness or problems with balance or coordination, headache, nausea (feeling sick) or vomiting, feeling tired, drowsy or sleepy. Serious side effects: feeling of depression, aggressive or agitated, spinning sensation, double vision or blurred vision.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of 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

4.9 Overdose

Symptoms. Symptoms observed after an accidental or intentional overdose of lacosamide are primarily associated with CNS and gastrointestinal system.
The types of adverse events experienced by patients exposed to doses above 400 mg up to 800 mg were not clinically different from those of patients administered recommended doses of lacosamide.
Events reported after an intake of more than 800 mg are dizziness, nausea, seizures (generalized tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, shock, and coma have also been observed. Fatalities have been reported in patients following an intake of acute single overdose of several grams of lacosamide.
Management of overdose. There is no specific antidote for overdose with lacosamide. Treatment of lacosamide overdose should include general supportive measures and may include haemodialysis if necessary (see Section 5.2 Pharmacokinetic Properties).
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Lacosamide was inactive in an in vitro mouse L5178Y lymphoma assay (tk locus) with positive or equivocal response only at excessive concentrations of 3 mg/mL (12 mM) and above. No genotoxicity was observed in tests for bacterial gene mutation in vitro and unscheduled DNA synthesis in rat hepatocytes ex vivo, or in an in vivo mouse micronucleus test for clastogenicity.
Carcinogenicity. Lacosamide did not show any tumourigenic responses in long-term carcinogenicity studies in mice and rats. The highest oral doses used resulted in systemic drug exposures (based on plasma AUC_0-24h) that were similar to (mice) or about three times (rats) that in humans treated with the maximum recommended dose.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLACOSA.gif Chemical name: (R)-2-acetamido-N-benzyl-3-methoxypropionamide.
Molecular formula: C₁₃H₁₈N₂O₃.
Molecular weight: 250.30.
CAS number. 175481-36-4.
The active ingredient lacosamide is a white to light yellow powder. It is sparingly soluble in water (30 mg/mL at 25°C) and slightly soluble in acetonitrile and ethanol.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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