Consumer Information for: LEVETIRACETAM
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
Levetiracetam Tablet 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 LEVETIRACETAM if you are allergic to levetiracetam or any of the other ingredients in LEVETIRACETAM listed in the “nonmedicinal ingredients” section below.
What the medicinal ingredient is
levetiracetam
What the non-medicinal ingredients are
Levetiracetam Tablet nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, macrogol, maize starch, polyvinyl alcohol - part hydrolysed, povidone, talc and titanium dioxide and coloring agents.
250 mg tablets: FD&C Blue # 2
500 mg tablets: Iron Oxide Yellow
750 mg tablets: FD&C Blue # 2, Iron Oxide Yellow and Iron
Oxide Red
What dosage form it comes in
Warnings and precautions
Because 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 LEVETIRACETAM affects you.
A small number of people may have thoughts of suicide (harming
or killing themselves) when taking antiepileptic drugs such as
LEVETIRACETAM.
If at any time you have these thoughts, immediately contact your
doctor. Do not discontinue 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:
BEFORE you use LEVETIRACETAM talk to your doctor or pharmacist if:
Interactions with this medication
Tell your doctor about all the medicines you take including
prescription or non-prescription medicines, vitamins or herbal
supplements. 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 may 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 LEVETIRACETAM and methotrexate together
can be harmful.
Proper use of this medication
Usual Adult Dose:
LEVETIRACETAM 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 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.
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
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 LEVETIRACETAM exactly as
your doctor has instructed. Do not stop taking it abruptly. Never
change the dose yourself. Do not stop taking
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:
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:
Other side effects include:
Some people may experience extreme sleepiness and tiredness and difficulty coordinating muscles normally.
Hair loss (alopecia) has been reported; in several cases when levetiracetam was discontinued, the hair grew back.
Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Seek Emergency Medical Attention |
---|---|---|---|
Uncommon | |||
Thoughts of suicide or hurting yourself | ✔ | ||
Rare | |||
Severe Allergic Reactions: swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, hives and generalized itching, rash, fever, abdominal cramps, chest discomfort or tightness, difficulty breathing, unconsciousness. | ✔ | ||
Serious skin reactions (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Reaction with Eosinophilia and Systemic Symptoms): any combination of itchy skin rash, redness, blistering and peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, bodyaches or swollen glands, joint pain, yellowing of the skin or eyes, dark urine. | ✔ | ||
Extreme sleepiness and tiredness and/or difficulty coordinating muscles normally. | ✔ | ||
Mood and behaviour changes such as anxiety, irritability or anger, depression, aggression, abnormal behaviour and agitation. | ✔ | ||
Worsening seizures | ✔ | ||
Unknown | |||
Psychotic symptoms: hallucination (seeing or hearing things that are not really there), delusions (false or strange thoughts or beliefs), paranoia (intense feeling of distrust, fear of persecution) and unusual behaviour | ✔ | ||
Rhabdomyolysis: muscle pain or weakness, dark urine | ✔ |
How to store
Store tablets between 15 – 30ºC. Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/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
If you want more information about LEVETIRACETAM:
This leaflet was prepared by:
Pharmascience Inc.
Montréal, Québec
H4P 2T4
Last revised: December 29, 2020
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