Dom-Levetiracetam: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Dom-LEVETIRACETAM is a prescription medicine used to help reduce the number of seizures when taken together with other seizure medicines, in adults 18 years and older.

What it does:

Levetiracetam belongs to the family of medicines called antiepileptics for treating epilepsy. The exact way that levetiracetam works to treat seizures is not known.

When it should not be used:

Do not take Dom-LEVETIRACETAM if you are allergic to levetiracetam or any of the other ingredients in Dom-LEVETIRACETAM listed in the “non-medicinal ingredients” section below.

What the medicinal ingredient is:

Levetiracetam

What the non-medicinal ingredients are:

Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Sodium Starch Glycolate and Talc.

The tablets also contain the following excipients:

250 mg: FD&C Blue #2, Hydroxypropyl methylcellulose,

Polyethylene Glycol, Polysorbate and Titanium Dioxide. 500 mg: Hydroxypropyl methylcellulose, Iron Oxide Black, Iron

Oxide Yellow, Polyethylene Glycol and Titanium Dioxide.

750 mg: Hydroxypropyl methylcellulose, Iron Oxide Red,

Polyethylene Glycol and Titanium Dioxide.

What dosage forms it comes in:

Tablets: 250 mg, 500 mg and 750 mg

WARNINGS AND PRECAUTIONS

Because Dom-LEVETIRACETAM can affect your mental alertness and coordination, it is very important not to perform any potentially hazardous tasks such as driving a car or operating machinery until you know how Dom-LEVETIRACETAM affects you.

A small number of people may have thoughts of suicide (harming or killing themselves) when taking antiepileptic drugs such as Dom-LEVETIRACETAM.

If at any time you have these thoughts, immediately contact your doctor. Do not discontinue Dom-LEVETIRACETAM on your own.

Severe Allergic Reaction Involving the Skin and Other Organs

There is no way to tell if a mild skin rash will become a severe reaction. Serious skin reactions known as Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported with levetiracetam. Although very rare, severe forms of these reactions may lead to death. Seek immediate medical attention if you develop any combination of:

• a rash or any serious skin reaction such as blistering or peeling of the lips, eyes or mouth
• fever
• swollen glands
• joint pain
• problems related to the liver, kidneys, heart, lungs or other organs
• allergic reactions (anaphylaxis or angioedema) such as swelling of the face, lips, eyes, tongue, and throat, trouble swallowing or breathing, and hives.

BEFORE you use Dom-LEVETIRACETAM talk to your doctor or pharmacist if:

• you have any health problems, including ones you have had in the past;
• you have kidney disease;
• you have ever shown unusual sensitivity (rash or any other signs of allergy) to any other antiepileptic drugs;
• you are taking any medication, including ones you can get without a prescription;
• you have recurrent infections or blood coagulation disorders;

• you are pregnant or thinking about becoming pregnant.

  Taking more than one antiepileptic medication during pregnancy increases the risk of birth defects. You and your doctor will have to decide if Dom-

  LEVETIRACETAM is right for you while you are pregnant. If you use Dom-LEVETIRACETAM 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

Dom-LEVETIRACETAM should call the pregnancy registry to enable collection of valuable data about Dom-LEVETIRACETAM use in pregnancy;

• you are breastfeeding. Dom-LEVETIRACETAM is

  known to pass into breast milk and may harm your baby. You and your doctor should decide whether you should take Dom-LEVETIRACETAM 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. Dom-LEVETIRACETAM and other medicines may affect each other.

If you are a female patient taking an oral contraceptive, watch for irregular menstruation or spotting and immediately report such occurrences to you doctor as this may be an indication that the oral contraceptive many not be working properly and you may get pregnant.

Tell your doctor if you are taking a drug called methotrexate, used to treat certain types of cancer, severe psoriasis, and rheumatoid arthritis. Taking Dom-LEVETIRACETAM and methotrexate together can be harmful.

PROPER USE OF THIS MEDICATION

Usual Adult Dose:

Dom-LEVETIRACETAM tablets are taken orally twice a day, once in the morning and once in the evening, at about the same time each day. The treatment with Dom-LEVETIRACETAM usually starts with a dose of 1,000 mg given half (500 mg) in the morning and half (500 mg) in the evening. After two weeks your dose may be increased. The typical daily maintenance dose is between 1,000 mg and 3,000 mg.

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

Dom-LEVETIRACETAM can be taken with or without food. After administration, the bitter taste of levetiracetam may be experienced.

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

It is very important that you take Dom-LEVETIRACETAM exactly as your doctor has instructed. Do not stop taking it abruptly. Never change the dose yourself. Do not stop taking Dom-LEVETIRACETAM 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 only for you. Do not give it to anybody else. If you require any further information or advice, please consult your doctor or pharmacist.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to take a dose, take it as soon as you remember, and then go on as usual. However, if it is almost time for your next dose; skip the dose you forgot and go on as usual. Do not take two doses at the same time.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most frequently observed side effects are:

• sleepiness
• weakness
• infection (such as a common cold)
• dizziness

Other side effects include:

• mood and behaviour changes such as anxiety, irritability or anger, depression, nervousness, personality disorder, and hostility
• lack of coordination
• vertigo (sensation of rotation)
• abnormal thinking
• loss of memory (amnesia)
• bruising
• toothache
• sore throat, runny nose, stuffed nose/head (sinusitis)

Some people may experience extreme sleepiness and tiredness and difficulty coordinating muscles normally.

Hair loss (alopecia) has been reported; in several cases when Dom-LEVETIRACETAM was discontinued, the hair grew back.

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

HOW TO STORE IT

Store tablets between 15 ºC and 30 ºC.

Keep out of reach and sight of children.

Reporting Side Effects

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

• Visiting the Web page on Adverse Reaction

  Reporting (http://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

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Dominion Pharmacal, at 1-888-550-6060.

Dominion Pharmacal

Montréal, Canada

H4P 2T4

Last revised: May 15, 2018