Details for: AG-LEVETIRACETAM
Company: ANGITA PHARMA INC.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02485192 | AG-LEVETIRACETAM | LEVETIRACETAM | 250 MG | TABLET | ORAL |
| 02485206 | AG-LEVETIRACETAM | LEVETIRACETAM | 500 MG | TABLET | ORAL |
| 02485214 | AG-LEVETIRACETAM | LEVETIRACETAM | 750 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
AG-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
AG-Levetiracetam belongs to the family of medicines called antiepileptics for treating epilepsy. The exact way that AGLevetiracetam works to treat seizures is not known.
When it should not be used
Do not take AG-Levetiracetam if you are allergic to levetiracetam or any of the other ingredients in AG-Levetiracetam listed in the “nonmedicinal ingredients” section below.
What the medicinal ingredient is
levetiracetam
What the non-medicinal ingredients are
AG-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: FD&C blue #2
500 mg: Iron Oxide Yellow
750 mg: FD&C yellow # 2, Iron Oxide Yellow and Iron Oxide Red
What dosage form it comes in
AG-Levetiracetam are available as tablets containing 250 mg, 500 mg, or 750 mg levetiracetam.
Warnings and precautions
Because AG-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 AG-Levetiracetam affects you.
A small number of people may have thoughts of suicide (harming or killing themselves) when taking antiepileptic drugs such as AG-Levetiracetam.
If at any time you have these thoughts, immediately contact your doctor. Do not discontinue AG-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.
- allergic reactions (anaphylaxis or angioedema) such as swelling of the face, lips, eyes, tongue, and throat, trouble swallowing or breathing, and hives.
BEFORE you use AG-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 have recurrent infections or blood coagulation disorders;
- 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 AG-Levetiracetam is right for you while you are pregnant. If you use AG-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 AGLevetiracetam should call the pregnancy registry to enable collection of valuable data about AGLevetiracetam
- ;
- 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 AGLevetiracetam 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. AG-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 AG-Levetiracetam and methotrexate together can be harmful.
Proper use of this medication
Usual Dose:
AG-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 AG-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.
AG-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 AGLevetiracetam, 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 AG-Levetiracetam exactly as your doctor has instructed. Do not stop taking it abruptly. Never change the dose yourself. Do not stop taking AG-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:
- 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)
- disinterest (apathy)
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 to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| 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. | ✔ | ||
| Extreme sleepiness and tiredness and/or difficulty coordinating muscles normally. | ✔ | ||
| Mood and behaviour changes such as anxiety, irritability or anger, depression, aggression, abnormal behavior and agitation. | ✔ | ||
| Unknown | |||
| Psychotic symptoms: hallucination (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs), paranoia (intense feeling of distrust, fear of persecution) and unusual behavior | ✔ | ||
| Rhabdomyolysis: muscle pain or weakness, dark urine | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking AG-Levetiracetam, contact your doctor or pharmacist.
How to store
Store tablets between 15 – 30 ºC. Keep out of reach and sight of children.
Reporting side effects
You can report any suspected adverse reactions 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-healthproducts/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
- Call 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 AG-Levetiracetam:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this sponsor Angita Pharma Inc. at: 450-449-9272.
This leaflet was prepared by:
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Date of Revision: January 25, 2021