Ava-Levetiracetam: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Ava-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 Ava-LEVETIRACETAM if you are allergic to levetiracetam or any of the other ingredients in Ava-LEVETIRACETAM listed in the “nonmedicinal ingredients” section below.

What the medicinal ingredient is:

levetiracetam

What the nonmedicinal 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 Ava-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 Ava-LEVETIRACETAM affects you.

A small number of people may have thoughts of suicide (harming

or killing themselves) when taking antiepileptic drugs such as Ava-LEVETIRACETAM.

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

If you experience any severe, unusual or allergic reactions, go to the emergency department at your nearest hospital. Signs of allergic reactions include: rash or blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals; swelling of the lips, eyelids, face, throat, or mouth, accompanied by difficulty in breathing, speaking, or swallowing.

BEFORE you use Ava-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 are taking any medication, including ones you can get without a prescription;

• you are pregnant or thinking about becoming pregnant.

  It is not known if Ava-LEVETIRACETAM may harm your unborn baby. You and your doctor will have to decide if Ava-LEVETIRACETAM is right for you while you are pregnant. If you use Ava-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 Ava-LEVETIRACETAM should call the pregnancy registry to enable collection of valuable data about Ava-LEVETIRACETAM use in pregnancy;

• you are breastfeeding. Ava-LEVETIRACETAM is known to pass into breast milk and may harm your baby. You and your doctor should decide whether you should take Ava-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. Ava-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.

PROPER USE OF THIS MEDICATION

Usual Adult Dose:

Ava-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 Ava-LEVETIRACETAM usually starts with a dose of 1000 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 1000 mg and 3000 mg.

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

Ava-LEVETIRACETAM can be taken with or without food.

If your doctor decides to stop your treatment with Ava-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 Ava-LEVETIRACETAM exactly as your doctor has instructed. Do not stop taking it abruptly. Never change the dose yourself. Do not stop taking Ava-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)
• rare types of severe skin rashes (often with fever, blisters, sore mouth/eyes, swollen lymph glands), including Steven-Johnson Syndrome, Toxic epidermal necrolysis, and Erythema Multiforme

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

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

This is not a complete list of side effects. For any unexpected effects while taking Ava-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 SUSPECTED 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 3 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, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ 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

This document plus the full product monograph, prepared for health professionals can be obtained by contacting AVANSTRA INC., at 1-855-708-3678.

10761-25^th Street NE, Suite# 110 Calgary, Alberta

T3N 0A4

Last revised: August 16, 2013.