NRA-Lacosamide: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

NRA-LACOSAMIDE is a prescription medicine used to treat partial-onset seizures when taken on its own or together with other seizure medicines in adults 18 years and older.

What it does:

NRA-LACOSAMIDE works in the brain to block the spread of seizure activity. The precise way that lacosamide works to treat partial-onset seizures is unknown.

When it should not be used:

Do not take NRA-LACOSAMIDE if:

• you are allergic to lacosamide or any of the other ingredients in NRA-LACOSAMIDE listed in the “nonmedicinal ingredients” section below.
• you suffer or have suffered in the past from a certain type of heart rhythm disorder (second or third degree AV block)

What the medicinal ingredient is:

Lacosamide

What the nonmedicinal ingredients are:

NRA-LACOSAMIDE Tablets nonmedicinal ingredients: Colloidal anhydrous silica, crospovidone, hydroxy propyl cellulose, low-substituted hydroxy propyl cellulose, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide and dye pigments:

50 mg tablets: red iron oxide, black iron oxide, FD&C Blue #2/indigo carmine aluminum lake

100 mg tablets: yellow iron oxide

150 mg tablets: yellow iron oxide, red iron oxide, black iron oxide

200 mg tablets: FD&C Blue #2/indigo carmine aluminum lake

What dosage forms it comes in:

Film-coated tablets: 50 mg, 100 mg, 150 mg and 200 mg

WARNINGS AND PRECAUTIONS

NRA-LACOSAMIDE may cause dizziness and poor coordination which could increase the risk of accidental injury or a fall. Therefore, you should be careful until you are used to the effects this medicine might have.

Do not drive, operate complex machinery, or engage in other hazardous activities until you know how NRA-LACOSAMIDE affects you. Ask your doctor when it is okay to do these activities.

NRA-LACOSAMIDE may cause double vision and blurred vision. If you experience visual disturbances while taking NRA-LACOSAMIDE, notify your doctor.

A small number of people being treated with anti-epileptics such as NRA-LACOSAMIDE have had thoughts of harming or killing themselves. If at any time you have these thoughts, immediately contact your doctor.

BEFORE you use NRA-LACOSAMIDE talk to your doctor or pharmacist if:

• you have any health problems, including ones you have had in the past;
• you have kidney or liver disease
• you are taking any medication, including ones you can get without a prescription;
• you are taking any medicine which can cause an abnormality on the ECG (electrocardiogram) called increased PR interval or heart block, for example medicines used to treat certain types of irregular heart beat or heart failure. If you are not sure that the medicines you are taking could have this effect, discuss this with your doctor (e.g. carbamazepine, pregabalin, lamotrigine, eslicarbazepine, beta-blockers, class I antiarrhythmic drugs, etc.)
• patients with pacemaker problems
• you suffer from a severe heart disease such as heart rhythm disorder, heart failure or heart attack;

• you are pregnant or plan to become pregnant. It is not known if NRA-LACOSAMIDE may harm your unborn baby. You and your doctor will have to decide if NRA-LACOSAMIDE is right for you while you are pregnant. If you use NRA-LACOSAMIDE while you are pregnant, ask your healthcare provider about joining the North American Antiepileptic Drug Pregnancy Registry by calling (888) 233-2334 (toll free).

  Women who are pregnant and planning to take NRA-LACOSAMIDE should call the pregnancy registry to enable collection of valuable data about NRA-LACOSAMIDE use in pregnancy. Information on the registry can also be found at the following website: http://www.aedpregnancyregistry.org/ ;

• you are breastfeeding. It is not known if NRA-LACOSAMIDE passes into breast milk and if it can harm your baby. You and your doctor should decide whether you should take NRA-LACOSAMIDE or breastfeed, but not both.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor about all the medicines you take including prescription or non-prescription medicines, vitamins or herbal supplements. NRA-LACOSAMIDE and other medicines may affect each other. Especially tell your doctor if you take:

• any medicines that make you sleepy or dizzy
• any medications to treat a heart condition
• carbamazepine, pregabalin, lamotrigine, eslicarbazepine, beta-blockers, class I antiarrhythmic drugs, etc.

PROPER USE OF THIS MEDICATION

NRA-LACOSAMIDE film-coated tablets:

• NRA-LACOSAMIDE may be taken with or without food.

• Swallow the tablets whole with plenty of water. Do not chew or crush tablets.

Usual Dose:

NRA-LACOSAMIDE must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

When you take NRA-LACOSAMIDE on its own: The treatment with NRA-LACOSAMIDE usually starts with 100 mg in the morning and 100 mg in the evening (200 mg a day). After one week your dose may be increased. The daily maintenance dose is between 200 mg and 600 mg.

When you take NRA-LACOSAMIDE with other seizure medicines:

The treatment with NRA-LACOSAMIDE usually starts with 50 mg in the morning and 50 mg in the evening (100 mg a day). After one week your dose may be increased. The daily maintenance dose is between 200 mg and 400 mg.

Your doctor may use a different dose if you have problems with your kidneys or liver.

If your doctor decides to stop your treatment with NRA-LACOSAMIDE, he/she will decrease the dose step by step. This is to prevent your symptoms from coming back again or becoming worse.

Do not stop taking NRA-LACOSAMIDE or any other seizure medicine unless your healthcare provider told you to. Stopping a seizure medicine all at once can cause seizures that will not stop (status epilepticus), a very serious problem.

Tell your healthcare provider if your seizures get worse or if you have any new types of seizures.

Remember: This medicine has been prescribed for you. Do not give it to anybody else.

Overdose:

If you think you have taken too much NRA-LACOSAMIDE, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose by a few hours, take it as soon as you remember. If it is close to your next dose, take NRA-LACOSAMIDE at your next regular time. Do not take two doses at the same time to make up for the missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects associated with the use of NRA-LACOSAMIDE are:

• dizziness, poor coordination
• headache
• nausea, vomiting, fatigue
• blurred vision, double vision

If you are elderly (older than 65), you may have a higher chance of the following side effects:

• falling
• diarrhea
• tremors/shaking

Tell your doctor about any side effect that bothers you or that does not go away.

This is not a complete list of side effects. For any unexpected effects while taking NRA-LACOSAMIDE, contact your doctor or pharmacist.

HOW TO STORE IT

• Store NRA-LACOSAMIDE at room temperature, 15 to 30°C.
• Keep NRA-LACOSAMIDE and all medicines out of the reach and sight of children.

REPORTING SIDE EFFECTS

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction

  Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-

  products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

If you want more information about NRA-LACOSAMIDE:

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website

  (https://www.canada.ca/en/health-

  canada/services/drugs-health-products/drug-products/drug-product-database.html); or by calling the sponsor Nora Pharma Inc. at 1-888-270-9874

Nora Pharma Inc.

40 rue Prince-Arthur, Suite 310

Saint-Lambert, Quebec

Canada J4P 1X2

Last revised: May 27, 2020