Patient Medication Information: uses, side effects, how to take - Priva-Levetiracetam
ABOUT THIS MEDICATION
What the medication is used for:
Priva-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:
Priva-LEVETIRACETAM belongs to the family of medicines called antiepileptics for treating epilepsy. The exact way that Priva-LEVETIRACETAM works to treat seizures is not known.
When it should not be used:
Do not take Priva-LEVETIRACETAM if you are allergic to levetiracetam or any of the other ingredients in Priva-LEVETIRACETAM listed in the “nonmedicinal ingredients” section below.
What the medicinal ingredient is:
levetiracetam
What the nonmedicinal ingredients are:
Priva-LEVETIRACETAM nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, macrogol, maize starch, polyvinyl alcohol - part hydrolysed, povidone, talc and titanium dioxide and coloring agents.
The individual tablets contain the following 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 forms it comes in:
Priva-LEVETIRACETAM is available as tablets containing 250 mg, 500 mg, or 750 mg levetiracetam.
WARNINGS AND PRECAUTIONS
Because Priva-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 Priva-LEVETIRACETAM affects you.
A small number of people may have thoughts of suicide (harming or killing themselves) when taking antiepileptic drugs such as Priva-LEVETIRACETAM.
If at any time you have these thoughts, immediately contact your doctor. Do not discontinue Priva-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:
- 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 or other organs.
BEFORE you use Priva-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 Priva-LEVETIRACETAM is right for you while you are pregnant. If you use Priva-LEVETIRACETAM while you are pregnant, ask your healthcare provider about joining the North American Antiepileptic Drug Pregnancy Women who are pregnant and planning to take Priva-LEVETIRACETAM should call the pregnancy
| IMPORTANT: PLEASE READ |
registry to enable collection of valuable data about Priva-LEVETIRACETAM use in pregnancy;
you are breastfeeding. Levetiracetam is known to pass
into breast milk and may harm your baby. You and your doctor should decide whether you should take Priva-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. Priva-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 THIS MEDICATION |
Usual Adult Dose:
Priva-LEVETIRACETAM is taken orally twice a day, once in the morning and once in the evening, at about the same time each day. The treatment with Priva-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.
Priva-LEVETIRACETAM can be taken with or without food.
If your doctor decides to stop your treatment with Priva-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 Priva-LEVETIRACETAM exactly as your doctor has instructed. Do not stop taking it abruptly. Never change the dose yourself. Do not stop taking Priva-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 levetiracetam was discontinued, the hair grew back.
IMPORTANT: PLEASE READ
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | ||||||
| HAPPEN AND WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Seek Emergency Medical Attention | ||||
| Only if severe | In all cases | |||||
| 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 (StevensJohnson 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, body aches 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. | √ | |||||
This is not a complete list of side effects. For any unexpected effects while taking Priva-LEVETIRACETAM, contact your doctor or pharmacist.
HOW TO STORE IT
Store tablets between 15°C –30ºC. 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 Pharmapar Inc.
Pharmapar Inc.
100-5950, Ch. de la Côte de Liesse
Mont-Royal, QC, H4T 1E2
Phone# (514) 731-2003; Fax: (514) 731-2004
Date of Preparation: January 6, 2016