Ran-Levetiracetam: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

RAN-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:

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

When it should not be used:

Do not take RAN-LEVETIRACETAM if you are allergic to LEVETIRACETAM or any of the other ingredients in RAN-LEVETIRACETAM listed in the “nonmedicinal ingredients” section below.

What the medicinal ingredient is:

Levetiracetam, USP

What the important nonmedicinal ingredients are:

Corn starch, sodium starch glycolate, colloidal silicon dioxide, povidone, talc, magnesium stearate, purified water, hypromellose, polyethylene glycol, titanium dioxide, FD & C blue #2 (250 mg only), ferric oxide yellow (500 mg only), ferric oxide red (750 mg only) and FD & C yellow #6 (750 mg only).

What dosage forms it comes in:

RAN-LEVETIRACETAM is available in 250 mg, 500 mg and 750 mg strengths.

WARNINGS AND PRECAUTIONS

Because RAN-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 RAN-LEVETIRACETAM affects you.

A small number of people may have thoughts of suicide (harming or killing themselves) when taking antiepileptic drugs such as RAN-LEVETIRACETAM. If at any time you have these thoughts, immediately contact your doctor. Do not discontinue RAN-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

ens-Johnson

drome (SJS), Toxic Epidermal Necrolysis (TEN), and

Drug Reaction with Eosinophilia and Systemic Symptoms

(DRESS) have been reported with RAN-

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 orother organs.

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

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

• you are breastfeeding. RAN-LEVETIRACETAM is

known to pass into breast milk and may harm your baby. You and your doctor should decide whether you should take RAN-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. RAN-

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:

RAN-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 RAN-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.

RAN-LEVETIRACETAM can be taken with or without food.

If your doctor decides to stop your treatment with RAN-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 RAN-

LEVETIRACETAM exactly as your doctor has instructed. Do not stop taking it abruptly. Never change the dose yourself. Do not stop taking RAN-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 pr

actitioner, hospital emergency department or regional

P

oison 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 RAN-LEVETIRACETAM was discontinued, the hair grew back.

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

HOW TO STORE IT

Store tablets between 15-30^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 0701D

  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 is available by contacting the distributor, Ranbaxy Pharmaceuticals Canada Inc., at 1-866-840-1340.

Last revised: February 19, 2015