Sandoz Levetiracetam: Uses, Side Effects and Dosage

What is Sandoz Levetiracetam used for?

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

How does Sandoz Levetiracetam work?

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

What are the ingredients in Sandoz Levetiracetam?

Medicinal ingredient: levetiracetam

Non-medicinal ingredients: colloidal silicon dioxide anhydrous, croscarmellose sodium, crospovidone, hypromellose, hydroxypropylcellulose, macrogol, magnesium stearate, microcrystalline cellulose, povidone, talc, titanium dioxide and coloring agents.

The tablets also contain the following non-medicinal ingredients:

250 mg: indigo carmine

500 mg: yellow iron oxide

750 mg: yellow iron oxide, red iron oxide

Sandoz Levetiracetam comes in the following dosage forms:

Film-coated tablets: 250 mg, 500 mg, 750 mg and 1000 mg

Do not use Sandoz Levetiracetam if:

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

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Sandoz Levetiracetam. Talk about any health conditions or problems you may have, including if you:

• 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 Sandoz Levetiracetam is right for you while you are pregnant.
  • If you use Sandoz 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 Sandoz Levetiracetam should call the pregnancy registry. It will enable the collection of valuable data about Sandoz 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 Sandoz 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.

Other warnings you should know about:

Driving and Operating Machinery: Sandoz Levetiracetam may affect your coordination and make you feel sleepy and tired. You should not drive or operate machinery until you know how Sandoz 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 Sandoz Levetiracetam. If at any time you have these thoughts, get medical help right away. Do NOT stop Sandoz 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 Sandoz Levetiracetam or your dose is increased
• if you take Sandoz Levetiracetam to treat seizures associated with a particular genetic mutation (i.e., SCN8A mutation). Sandoz 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.

The following may interact with Sandoz Levetiracetam:

• Other antiepileptic medicines (such as carbamazepine, topiramate)
• Methotrexate (used to treat certain types of cancer and arthritis)
• Oral contraceptives (used for birth control)

How to take Sandoz Levetiracetam:

• Take Sandoz Levetiracetam exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
• Take Sandoz Levetiracetam in the morning and in the evening at about the same time each day.

• Sandoz Levetiracetam can be taken with or without food.

• Swallow the tablets with water.
• After taking Sandoz 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.

Usual Dose

• The usual starting dose of Sandoz 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 Sandoz Levetiracetam, they will decrease the dose slowly. This is to help prevent your symptoms from coming back again or becoming worse.

• Do NOT stop taking Sandoz 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

Overdose

If you think you, or a person you are caring for, have taken too much Sandoz Levetiracetam, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or 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 continue with your next scheduled dose. Do not take two doses at the same time.

What are possible side effects from using Sandoz Levetiracetam?

These are not all the possible side effects you may have when taking Sandoz 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

Serious side effects and what to do about them

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.

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 (canada.ca/drug-device-reporting) 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.

Storage

Store tablets at room temperature between 15-30°C.

Keep out of reach and sight of children.

If you want more information about Sandoz Levetiracetam:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (https://www.sandoz.ca/en), or by calling 1-800-361-3062.

Last revised: OCT 24, 2025