Patient Medication Information: uses, side effects, how to take - Nu-Levetiracetam
ABOUT THIS MEDICATION
What the medication is used for:
NU-LEVETIRACETAM is used to treat epilepsy.
What it does:
NU-LEVETIRACETAM belongs to the family of medicines called antiepileptics for treating epilepsy. NU-LEVETIRACETAM has been prescribed for you by your doctor to reduce your number of seizures. It is taken with other seizure medications to help control seizures.
When it should not be used:
Do not take NU-LEVETIRACETAM if you have had an allergic reaction to NU-LEVETIRACETAM or any of the ingredients listed at the end of this information. Signs of allergic reaction may include a skin rash, itching, shortness of breath or swelling of the face, lips or tongue.
What the medicinal ingredient is:
NU-LEVETIRACETAM tablets contain the active ingredient called levetiracetam.
What the important nonmedicinal ingredients are:
NU-LEVETIRACETAM tablets contain the following inactive ingredients: copovidone, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide, anhydrous citric acid and coloring agents. The individual tablets contain the following coloring agents: 250 mg: FD&C Blue No. 2 Aluminum Lake, 500 mg: yellow ferric oxide, 750 mg: yellow ferric oxide and red ferric oxide.
What dosage forms it comes in:
NU-LEVETIRACETAM tablets are available in 250 mg, 500 mg and 750 mg strengths.
WARNINGS AND PRECAUTIONS
Before starting NU-LEVETIRACETAM and to get the best possible treatment, be sure to tell your doctor:
- About all your medical conditions, especially if you have any kidney disease.
If you are pregnant or thinking about becoming pregnant. NU-
LEVETIRACETAM should not be used in pregnancy unless the doctor believes the benefits outweigh the risks. Your doctor may advise that you register with the Antiepileptic Drug Pregnancy Register.
- If you are breast-feeding or considering to breastfeed your infant. Levetiracetam is excreted in breast milk. You and your doctor should discuss this issue.
- Any other medicines (prescription and nonprescription) you are taking.
When taking NU-LEVETIRACETAM, it is very important not to perform any potentially hazardous tasks such as driving a car or operating dangerous machinery until you are sure this medication does not affect your mental alertness or physical coordination.
- A very small number of people may have thoughts of suicide.
- If you are a female patient taking an oral contraceptive, watch for irregular menstruation or spotting and immediately report such occurrences to your doctor as this may be an indication that the oral contraceptive may not be working properly and you may get pregnant.
This medicine has been prescribed only for you. Do not give it to anybody else.
INTERACTIONS WITH THIS MEDICATION
Consult your doctor before taking any other medicines (prescription or nonprescription).
PROPER USE OF THIS MEDICATION
Usual Adult Dose:
It is very important that you take NU-
LEVETIRACETAM exactly as your doctor has instructed.
- Never change the dose yourself.
- Do not stop taking it abruptly.
NU-LEVETIRACETAM tablets are taken
orally twice a day (typically morning and evening). NU-LEVETIRACETAM can be taken with or without food.
Overdose:
Contact your doctor or nearest hospital emergency department, even though you may not feel sick.
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 missed and go on as usual. Do not take a double dose of this medication.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like other medicines, NU-LEVETIRACETAM can cause some side effects. The most common side effects of NU-LEVETIRACETAM are:
The most frequently observed side effects are
somnolence (sleepiness), asthenia (weakness), infection (such as common cold) and dizziness. Other side effects include: abnormal thinking, amnesia (loss of memory), anxiety, ataxia (lack of coordination), depression, ecchymosis (bruising), emotional lability (mood swings), hostility, nervousness, personality disorder, pharyngitis (sore throat), rhinitis (runny nose), sinusitis (stuffed head), tooth disorders (toothache), vertigo (sensation of rotation).
Some people may experience extreme sleepiness
and tiredness and difficulty coordinating muscles normally. Mood and behavior changes such as anxiety, irritability or anger, and depression can also happen to some people.
Some people may experience blood disorders, a
reduction in numbers of certain types of blood cells (white blood cells, neutrophils, leukocytes) in
conditions such as neutropenia, leukopenia, and thrombocytopenia.
This is not a complete list of side effects. For any unexpected effects while taking NU-LEVETIRACETAM, contact your doctor or pharmacist.
HOW TO STORE IT
Store tablets between 15-30˚C (59-86˚F).
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated wit 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 0701C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the Med Effect ™ Canada Web site at www.healtlcanada.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
For more information, please contact your doctor, pharmacist or other healthcare professional.
This leaflet plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Nu-Pharm, Inc. at:
1-800-267-1438
Date of Revision: October 14, 2009