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Details for: MINT-LACOSAMIDE

Company: MINT PHARMACEUTICALS INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02490544MINT-LACOSAMIDELACOSAMIDE50 MGTABLETORAL
02490552MINT-LACOSAMIDELACOSAMIDE100 MGTABLETORAL
02490560MINT-LACOSAMIDELACOSAMIDE150 MGTABLETORAL
02490579MINT-LACOSAMIDELACOSAMIDE200 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

MINT-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

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

When it should not be used

Do not take MINT-LACOSAMIDE if:

  • you are allergic to lacosamide or any of the other ingredients in MINT-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 non-medicinal ingredients are

MINT-LACOSAMIDE Tablets nonmedicinal ingredients: colloidal anhydrous silica, crospovidone, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol-part hydrolyzed, talc, titanium dioxide, lecithin and the following coloring agents:

50 mg tablets: iron oxide red, indigo carmine aluminum lake and iron oxide black.
100 mg tablets:
iron oxide yellow.
150 mg tablets: iron oxide yellow, iron oxide red and iron oxide black.
200 mg tablets: indigo carmine aluminum lake.

What dosage form it comes in

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

Warnings and precautions

MINT-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 MINTLACOSAMIDE affects you. Ask your doctor when it is okay to do these activities.

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

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

BEFORE you use MINT-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 MINT-LACOSAMIDE may harm your unborn baby. You and your doctor will have to decide if MINT-LACOSAMIDE is right for you while you are pregnant. If you use MINTLACOSAMIDE 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 MINTLACOSAMIDE should call the pregnancy registry to enable collection of valuable data about MINTLACOSAMIDE 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 MINTLACOSAMIDE passes into breast milk and if it can harm your baby. You and your doctor should decide whether you should take MINTLACOSAMIDE 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. MINT-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

MINT-LACOSAMIDE film-coated tablets:

  • MINT-LACOSAMIDE may be taken with or without food.
  • Swallow the tablets whole with plenty of water. Do not chew or crush tablets.

Usual Dose

MINT-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 MINT-LACOSAMIDE on its own:
The treatment with MINT-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 MINT-LACOSAMIDE with other seizure medicines:
The treatment with MINT-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 MINTLACOSAMIDE, 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 MINT-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 MINT-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 MINTLACOSAMIDE 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 MINT-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.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and get immediate medical help
Uncommon
Thoughts of suicide or hurting yourself    
Allergic reaction: swelling in the mouth, tongue, face and throat, itching, rash    
Heart rhythm problems: irregular pulse, slow pulse, rapid pulse, palpitations, shortness of breath, feeling lightheaded, fainting    
Uncommon
Allergic reactions that typically present with fever, rash and swollen lymph nodes, and may be associated with signs and symptoms involving other organs, e.g. liver.    
Liver disorder or liver injury: itching, right upper belly pain, dark urine, yellow skin or eyes, unexplained flu-like symptoms    

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

How to store

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

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to:
      Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about MINT-LACOSAMIDE:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer's website www.mintpharmaceuticals.com, or by calling 1- 877-398-9696.
This leaflet was prepared by:
Mint Pharmaceuticals Inc.
1093 Meyerside Drive, Unit 1
Mississauga, ON, L5T 1J6
Canada

Last Prepared: July 12, 2019

Date modified: