Consumer Information for: AG-LEVETIRACETAM

AG-Levetiracetam is used in adults to help reduce the number of seizures. It is to be used with other seizure medicines.

AG-Levetiracetam belongs to the family of medicines called antiepileptics for treating epilepsy. The exact way that AG-Levetiracetam works to treat seizures is not known.

Medicinal ingredient: levetiracetam

Non-medicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, magnesium stearate, macrogol, maize starch, polyvinyl alcohol - part hydrolysed, povidone, talc, titanium dioxide and coloring agents.

The tablets also contain the following non-medicinal ingredients:

250 mg: FD&C Blue No. 2

500 mg: Iron Oxide Yellow

750 mg: FD&C Blue No. 2, Iron Oxide Yellow and Iron Oxide Red

Tablets: 250 mg, 500 mg, and 750 mg

• you are allergic to levetiracetam or to any of the other ingredients in AG-Levetiracetam (see What are the ingredients in AG-Levetiracetam?).

• have any health problems, including ones you have had in the past

• have kidney disease

• have had to ever shown unusual sensitivity (rash or any other signs of allergy) to any other antiepileptic drugs

• have recurrent infections or blood coagulation disorders

• have or have had a history of any heart problems or problems with the way your heart beats

• take any medicines that affect the heart or how it beats

• are pregnant or thinking about becoming pregnant. Taking more than one antiepileptic medication during pregnancy increases the risk of birth defects.

  • You and your healthcare professional 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 AG-Levetiracetam should call the pregnancy registry. It will enable the collection of valuable data about AG-Levetiracetam use in pregnancy.

• are breastfeeding or planning to breastfeed. Levetiracetam is known to pass into breast milk and may harm your baby. You and your healthcare professional should decide whether you should take AG-Levetiracetam or breastfeed, but not both.

• are 65 years of age or older

• have severe liver problems

• are of Japanese descent

• have seizures associated with a particular genetic mutation called SCN8A mutation. Ask your healthcare professional if you are unsure.

Driving and Operating Machinery: AG-Levetiracetam may affect your coordination and make you feel sleepy and tired. You should not drive or operate machinery until you know how AG-Levetiracetam affects you.

Changes in behaviour: You should pay attention to any mental changes, especially sudden changes in your mood, behaviours, thoughts, or feelings. Call your healthcare professional right away, if you have any changes in behaviour that are new, worse, or worry you. These changes could include:

• feeling depressed, nervous, or anxious;

• feeling angry, agitated or hostile;

• in some people, psychotic symptoms, such as hallucinations (seeing or hearing things that are not really there); delusions (false or strange thoughts or beliefs), and unusual behaviour.

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, get medical help right away. Do NOT stop 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. The following serious skin reactions have been reported with levetiracetam:

• Stevens-Johnson Syndrome (SJS)

• Toxic Epidermal Necrolysis (TEN)

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Although very rare, severe forms of these reactions may lead to death. Get help right away if you develop any combination of the following:

• 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

Worsening Seizures: Your seizures may get worse:

• when you begin your treatment with AG-Levetiracetam or your dose is increased;

• if you take AG-Levetiracetam to treat seizures associated with a particular genetic mutation (i.e., SCN8A mutation). AG-Levetiracetam may also be ineffective in treating these seizures.

Tell your healthcare professional if you notice your seizures remain present. If they get worse, tell your healthcare professional right away.

See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

• Other antiepileptic medicines (such as carbamazepine, topiramate)

• Methotrexate (used to treat certain types of cancer and arthritis)

• Oral contraceptives (used for birth control)

• Take AG-Levetiracetam exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.

• Take AG-Levetiracetam in the morning and in the evening at about the same time each day.

• AG-Levetiracetam can be taken with or without food.

• Swallow the tablets with water.

• After taking AG-Levetiracetam you may have a bitter taste in your mouth.

Remember: This medicine has been prescribed only for you. Do not give it to anybody else.

• The usual starting dose of AG-Levetiracetam is 500 mg twice a day, once in the morning and once in the evening.

• Based on your response and your tolerability, your healthcare professional may increase your daily dose.

• Your healthcare professional may prescribe you a different dose if you have problems with your kidneys.

Stopping treatment: If your healthcare professional decides to stop your treatment with AGLevetiracetam, they will decrease the dose slowly. This is to help prevent your symptoms from coming back again or becoming worse.

• Do NOT stop taking AG-Levetiracetam unless your healthcare professional has told you to. Stopping a seizure medicine suddenly can cause you to have seizures that will not stop (status epilepticus). This can be very serious.

• Never change the dose yourself

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 continue with your next scheduled dose. Do not take two doses at the same time.

These are not all the possible side effects you may have when taking AG-Levetiracetam. If you experience any side effects not listed here, tell your healthcare professional. The most frequently observed side effects are:

• Sleepiness

• lack or loss of strength

• infection (such as a common cold)

• dizziness

Other side effects include:

• vertigo (sensation of rotation)

• loss of memory (amnesia)

• bruising

• toothache

• sore throat, runny nose, stuffed nose/head (sinusitis)

• hair loss (alopecia)

• headache

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Store tablets between 15-30 °C. Keep out of reach and sight of children.

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drugproducts/drug- product-database.html); or by calling 450-449-9272.

This leaflet was prepared by:

Angita Pharma Inc. 1310 rue Nobel

Boucherville, Quebec

J4B 5H3, Canada

Last Revised: NOV 01, 2023