Patient Medication Information: uses, side effects, how to take - PHL-Levetiracetam
ABOUT THIS MEDICATION
What the medication is used for:
phl-LEVETIRACETAM belongs to the family of medicines called antiepileptics for treating epilepsy. phl-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.
What it does:
Levetiracetam is an antiepileptic drug (AED) which is different from existing AEDs. It has antiseizure and antiepileptic activity. The exact mechanism of action is not known, but it appears to be unlike that of commonly used AEDs.
When it should not be used:
You should not use phl-LEVETIRACETAM if you are allergic to any of the ingredients in the product. See what the non-medicinal ingredients are. Contact your doctor immediately if you experience an allergic reaction or any severe or unusual side effects.
What the medicinal ingredient is:
levetiracetam
What the nonmedicinal ingredients are: phl-LEVETIRACETAM Tablets also contain the following inactive ingredients (alphabetically): Colloidal Silicon Dioxide, Corn Starch, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Purified Water, Sodium Starch and Talc.
phl-LEVETIRACETAM 250 mg tablets contain also the following excipients:
FD&C Blue # 2, Hydroxypropyl methylcellulose, Hydroxypropyl methylcellulose, Polyethylene glycol, Polysorbate and Titanium Dioxide.
phl-LEVETIRACETAM 500 mg tablets also contain the following excipients:
Hydroxypropyl methylcellulose, Iron Oxide Black, Iron Oxide Yellow, Polyethylene glycol and Titanium Dioxide.
phl-LEVETIRACETAM 750 mg tablets contain also the following excipients:
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
Important points you must tell your doctor before taking phl-LEVETIRACETAM:
C About all your medical conditions, especially if you have any kidney disease.
C If you are pregnant or thinking about becoming pregnant, or if you are breast-feeding. C Any other medicines (prescription and nonprescription) you are taking.
Contract your doctor immediately if you experience any severe, unusual or allergic reactions.
C When taking phl-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 C A very small number of people may have thoughts of suicide.
C 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.
INTERACTIONS WITH THIS MEDICATION
Interactions with this medication and other drugs have not generally been observed. However, you should tell your doctor and pharmacist if you are using oral contraceptives and what prescription and non-prescription medications, vitamins, nutritional supplements and herbal products you are taking.
PROPER USE OF THIS MEDICATION
C It is very important that you take phl-
LEVETIRACETAM exactly as your doctor has instructed.
C Never change the dose yourself.
C Do not stop taking it abruptly.
C phl-LEVETIRACETAM tablets are taken
orally twice a day (typically morning and evening). phl-LEVETIRACETAM can be taken with or without food.
C Consult your doctor before taking any other
medicines (prescription or nonprescription).
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.
Overdose
Contact your doctor or nearest hospital emergency department, even though you may not feel sick.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
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) and vertigo (sensation of rotation).
| SERIOUS SIDE EFFECTS | ||||||
| AND WHAT TO DO ABOUT THEM | ||||||
| Symptom/effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmac ist | ||||
Only if severe | In all cases | |||||
| Extreme sleepiness or tiredness | / | |||||
Extreme weakness or difficulty coordinating muscles normally | / | |||||
Mood and behavior changes such as anxiety, irritability or anger and depression | / |
This is not a complete list of side effects. If you have any unexpected effects while taking this drug, contact your doctor or pharmacist.
HOW TO STORE IT
phl-LEVETIRACETAM Tablets should be stored between 15º C and 30º C.
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax: 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Health Canada
Address Locator: 0701C
Ottawa, ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be obtained by contacting Pharmel Inc. at 1-888-550-6060.