Patient Medication Information: uses, side effects, how to take - Apo-Oxcarbazepine

Serious warnings and precautions box

Blood Disorders: APO-OXCARBAZEPINE has been reported to cause serious adverse effects such as:
- agranulocytosis (low white blood cell levels),
- aplastic anemia (when cells meant to develop into mature blood cells are damaged),
- leucopenia (low white blood cell levels),
- thrombocytopenia (low blood platelet levels), and
- hepatitis (inflammation of the liver).

Your healthcare professional will closely monitor your health for potential signs and symptoms of these blood disorders. If bone marrow depression appears, your healthcare professional may stop your treatment with APO-OXCARBAZEPINE.

Skin Reactions: APO-OXCARBAZEPINE can also cause serious and sometimes fatal skin reactions such as:
- Stevens-Johnson Syndrome (SJS),
- Toxic Epidermal Necrolysis (TEN),
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS),
- Acute Generalized Exanthematous Pustulosis (AGEP), and
- Maculopapular rash.

Some of these skin reactions are genetically linked, especially if you are of Asian descent. Your healthcare professional may perform a blood test to determine if APO-OXCARBAZEPINE is suitable for you.

Tell your healthcare professional right away if you notice or develop a rash or any serious skin reactions. This can include red skin, blistering of the lips, eyes or mouth, and skin peeling accompanied by fever. Your healthcare professional may stop your treatment with APO-OXCARBAZEPINE.

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

What APO-OXCARBAZEPINE is used for:

APO-OXCARBAZEPINE is used alone or with other medicines to treat partial seizures in adults and children (6 to 16 years of age).

How APO-OXCARBAZEPINE works:

APO-OXCARBAZEPINE is an anticonvulsant or antiepileptic drug used to treat epilepsy. It is thought to work by keeping the brain’s “overexcitable” nerve cells under control. This may help to suppress or reduce the frequency of partial seizures.

The ingredients in APO-OXCARBAZEPINE are:

Medicinal ingredient: Oxcarbazepine

Non-medicinal ingredients: Colloidal silicon dioxide, crospovidone, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methylcellulose, polyethylene glycol and titanium dioxide.

APO-OXCARBAZEPINE comes in the following dosage forms:

Tablets: 150 mg, 300 mg and 600 mg.

Do not use APO-OXCARBAZEPINE if:

you are allergic to oxcarbazepine, eslicarbazepine acetate (an ingredient related to oxcarbazepine), or any of the other ingredients in APO-OXCARBAZEPINE.

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

have a history of allergic reactions to carbamazepine (such as a rash);
have or had kidney problems;
have or had liver problems;
have or had heart problems;
are of an Asian descent;
are taking other antiepileptic medicines (used to treat epilepsy);
are pregnant or plan to become pregnant;
are breastfeeding or plan to breastfeed;
are taking diuretic medicines (used to get rid of salt and water by increasing the amount of urine produced);
have low sodium levels in your blood level;
have a history, or family history, of bone disease.

Other warnings you should know about:

APO-OXCARBAZEPINE can cause the following:

Bone disorders: Treatment with antiepileptic drugs, such as oxcarbazepine, for long periods can decrease bone mineral density. This may lead to weakened or brittle bones.
Hyponatremia (low sodium levels in the blood): Treatment with APO-OXCARBAZEPINE can cause hyponatremia. Your healthcare professional will monitor you/your child closely for signs and symptoms of hyponatremia. They may decide to reduce or stop your treatment with APO-OXCARBAZEPINE.
Hypothyroidism (underactive/low thyroid): Treatment with APO-OXCARBAZEPINE can cause hypothyroidism. Your healthcare professional will monitor the status of your thyroid hormone levels, especially in children. They may decide to reduce or stop your treatment with APO-OXCARBAZEPINE.
Mental and motor impairment: Treatment with APO-OXCARBAZEPINE can affect your mental and motor performance. This can cause difficulty with concentration, speech problems, language problems, drowsiness, fatigue, coordination abnormalities, ataxia, and walking problems. Tell your healthcare professional if you experience any of these symptoms.
Seizure aggravation: Treatment with APO-OXCARBAZEPINE has been associated with seizure aggravation, especially in children. If you notice you are having more seizures or changes in the pattern of your seizures, tell your healthcare professional right away. They will determine if your dose should be reduced or stopped.
Suicidal thoughts or behaviour: Antiepileptic drugs, such as APO-OXCARBAZEPINE, can increase the risk of suicidal thoughts and behaviours (harming or killing themselves). If at any time you have these thoughts, contact 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.

Pregnancy:

If you are able to get pregnant, plan to become pregnant, are pregnant, or are taking hormonal birth control, there are specific risks you should discuss with your healthcare professional.

APO-OXCARBAZEPINE can affect hormonal birth control drugs such as “the pill”. Therefore, you should use either a different method of birth control or an additional non-hormonal method while you are taking APO-OXCARBAZEPINE. This should help to prevent an unwanted pregnancy. Tell your healthcare professional right away, if you get irregular vaginal bleeding or spotting. If you have any questions about this, talk to your healthcare professional.
There may be a risk to your baby if you take antiepileptic drugs during pregnancy. Tell your healthcare professional if you are pregnant or plan to become pregnant. They will discuss the benefits and potential risks with you and help you to decide whether you should take APO-OXCARBAZEPINE.
Taking APO-OXCARBAZEPINE during pregnancy can also affect the amount of oxcarbazepine in your blood. Your healthcare professional may recommend regular blood testing during your pregnancy to check that APO-OXCARBAZEPINE is appropriately controlling your seizures.
Antiepileptic drugs, such as APO-OXCARBAZEPINE, can decrease your levels of folic acid.
- This can lead to fetal abnormality. Your healthcare professional may recommend taking folic acid supplements before and during pregnancy.
Stopping APO-OXCARBAZEPINE abruptly can worsen your seizures. Do not stop your treatment with APO-OXCARBAZEPINE during pregnancy without first checking with your healthcare professional.

Breastfeeding:

The active ingredient in APO-OXCARBAZEPINE can pass into breast milk. This could cause side effects for breast-fed babies. Talk with your health care professional about the risks and benefits of breastfeeding while taking APO-OXCARBAZEPINE.

Tests and Monitoring: Your healthcare professional may assess your health before and during your treatment with APO-OXCARBAZEPINE. This can include blood tests to identify your genetics, assess your sodium levels, assess thyroid hormone levels, and monitor the levels of the drug.

Driving and using machines: APO-OXCARBAZEPINE can cause dizziness, drowsiness, visual disturbances, blurred visions, and hyponatremia (low sodium levels in the blood), especially at the beginning of your treatment. Before you drive or do tasks that require special attention, wait until you know how you respond to APO-OXCARBAZEPINE.

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 APO-OXCARBAZEPINE:

hormonal contraceptives that contain ethinylestradiol and levonorgestrel such as the birth-control pill.
other antiepileptic medicines such as carbamazepine, phenobarbital, phenytoin, valproic acid, lamotrigine, and phenytoin.
medicines that are used to treat bacterial infections such as rifampicin.
medicines known as calcium antagonists that decrease blood pressure such as felodipine and verapamil.
medicines that reduce the level of sodium in your blood such as diuretics (increases the amount of urine produced to help the kidneys get rid of salt and water).
medicines that can affect your body’s immune system such as cyclosporine.
alcohol which may increase the sedative effects (making you more sleepy). Avoid alcohol as much as possible and ask your healthcare professional for advice.

How to take APO-OXCARBAZEPINE:

APO-OXCARBAZEPINE should be taken twice a day at about the same time of every day.
APO-OXCARBAZEPINE can be taken with or without food.
Do not stop your treatment with APO-OXCARBAZEPINE without first checking with your healthcare professional. To prevent sudden worsening of your seizure, your healthcare professional will not discontinue your medicine abruptly.

Usual dose:

Your healthcare professional will determine the right dose for you/your child depending on your unique situation. Take APO-OXCARBAZEPINE exactly as prescribed by your healthcare professional. Your healthcare professional may start with a low dose and slowly adjust the dose as needed.

Overdose:

If you think you, or a person you are caring for, have taken too much APO-OXCARBAZEPINE, contact a healthcare professional, hospital emergency department, 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/your child miss/misses one dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose. Instead, take the next scheduled regular dose. Do not double the dose at any time.

If you have forgotten to take several doses, contact your healthcare professional.

Possible side effects from using APO-OXCARBAZEPINE:

These are not all the possible side effects you may have when taking APO-OXCARBAZEPINE. If you experience any side effects not listed here, tell your healthcare professional.

The most common side-effects may include:

sleepiness
unsteadiness
diarrhea
double vision
abnormal vision
uncontrolled eye movement
blurred vision
abnormal gait (unable to walk normally)
anxiety
nervousness
feeling of depression
mood swing
memory problems
difficulty concentrating
apathy (feeling indifferent/loss of interest)
agitation
trembling
problems with muscle coordination
acne
weight increase

There have been reports of bone disorders including osteopenia and osteoporosis (thinning of the bone) and fractures in patients on long term-treatment with APO-OXCARBAZEPINE.

Serious side effects and what to do about them

Frequency / Side Effect / Symptom	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Frequency / Side Effect / Symptom	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
Only if severe	In all cases
Uncommon
Decreased white blood cells: frequent infections with fever, chills, sore throat, or mouth ulcers		√
Rare
Suicidal thoughts or actions: thoughts, plans and actions taken for the purpose of killing or harming yourself		√
Very rare
Allergic reactions: swelling of the lips, eyelids, face, throat, or mouth, difficulty in breathing, speaking or swallowing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives, or rash			√
Hypersensitivity reactions: skin rash, hives, itching, shortness of breath, wheezing, runny nose, watery eyes, fever, swollen glands (swelling of the lymph nodes), and pain in the muscles and joints			√
Serious skin reactions (including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Acute Generalized Exanthematous Pustulosis (AGEP), and maculopapular rash): blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals, rash, hives, itching, dermatitis, redness, blistering, or peeling of skin			√
Systemic lupus erythematosus (an autoimmune disease that occurs when your body’s immune system attacks your own tissues and organs, including your joints, skin, kidneys, blood cells, heart and lungs): fatigue, fever, joint pain, stiffness, swelling, rash on the face hat covers the cheeks and the bridge of the nose or rashes elsewhere on the body, skin lesions, shortness of breath, chest pain, dry eyes, headaches, confusion, or memory loss			√
Decrease blood cells: tiredness, shortness of breath when exercising, looking pale, headache, chills, dizziness, frequent		√
infections leading to fever, sore throat, mouth ulcers
Thrombocytopenia (low blood platelets): bleeding or bruising more easily and/or longer than usual if you hurt yourself, nose bleeds, reddish or purplish patches, unexplained blotches on the skin, skin that is red or warm, coldness, tingling, numbness, pale skin, muscle pain, muscle spasms, or weakness		√
Hyponatremia (low sodium in the blood): lack of energy, confusion, muscular twitching, achy, stiff, uncoordinated muscles, coma, or significant worsening of convulsions		√
Hepatitis (inflammation of the liver): nausea, loss of appetite, vomiting combined with itching, upper stomach (abdominal) pain, yellowing of the skin or eyes, fatigue, fever, light coloured stool, trouble thinking clearly, or yellowing of the skin		√
Flu-like symptoms accompanied with liver disorders		√
Hypothyroidism (underactive/low thyroid): weight gain, tiredness, hair loss, muscle weakness, feeling cold, dry skin, constipation, puffy face, heavier than normal or irregular menstrual periods, or enlarged thyroid gland		√

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 healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

The tablets should be stored at room temperature 15°C - 30°C. Do not use APO-OXCARBAZEPINE after the expiry date which is printed on the label.
Do not use any APO-OXCARBAZEPINE pack that is damaged or show signs of tampering.
Keep APO-OXCARBAZEPINE out of reach and sight of children.

If you want more information about APO-OXCARBAZEPINE:

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 website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (http://www.apotex.ca/products); or by calling 1-800-667-4708.

Date of Authorization: 2026-02-09

Apo-Oxcarbazepine: Uses, Side Effects and Dosage