Details for: APO-OXCARBAZEPINE
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02284294 | APO-OXCARBAZEPINE | OXCARBAZEPINE | 150 MG | TABLET | ORAL |
| 02284308 | APO-OXCARBAZEPINE | OXCARBAZEPINE | 300 MG | TABLET | ORAL |
| 02284316 | APO-OXCARBAZEPINE | OXCARBAZEPINE | 600 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
APO-OXCARBAZEPINE belongs to a group of medicines called anticonvulsants or antiepileptics (medicines to treat epilepsy).
Epilepsy is a brain disorder that causes people to have recurring seizures and convulsions. Seizures happen because of a temporary fault in the brain’s electrical activity. Normally brain cells coordinate body movements by sending out signals through the nerves to the muscles in an organised, orderly way. In epilepsy, brain cells send out too many signals in a disorderly fashion. The result can be uncontrolled movements of muscles that we call an epileptic seizure.
There are two main classes of epileptic seizures, generalized and partial. Generalized seizures involve a wide area of the brain, cause loss of consciousness and can affect the whole body. There are two main types of generalized seizures: tonic-clonic seizures (grand mal) and absence seizures (petit mal).
Partial seizures involve a limited area of the brain (i.e., focal origin), but may spread to the whole brain and may cause a secondarily generalized tonic-clonic (grand mal) seizure. There are two types of partial seizures: simple and complex. In simple partial seizures, the patient remains conscious, whereas in complex partial seizures, patients lose consciousness.
APO-OXCARBAZEPINE is used to treat partial seizures.
Usually, the doctor will attempt to find the one drug that works best but, with more severe epilepsy, a combination of two or more drugs may be needed to control seizures. APO-OXCARBAZEPINE can be used alone (i.e., monotherapy) or in combination with other antiepileptic drugs.
This medicine has been prescribed for you personally (or your child) and you should not give it to others.
What it does
APO-OXCARBAZEPINE is thought to work by keeping the brain’s “overexcitable” nerve cells under control, which may help to suppress or reduce the frequency of such seizures.
When it should not be used
If you are allergic (hypersensitive) to oxcarbazepine or eslicarbazepine acetate (another active substance related to oxcarbazepine) or to any of the other substances listed in ‘What the nonmedicinal ingredients are’.
What the medicinal ingredient is
Oxcarbazepine
What the non-medicinal ingredients are
APO-OXCARBAZEPINE 150 mg, 300 mg and 600 mg tablets contains the following nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, ferric oxide yellow, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methylcellulose, polyethylene glycol, purified water, titanium dioxide and yellow ferric oxide.
What dosage form it comes in
APO-OXCARBAZEPINE is available in tablets of 150 mg, 300 mg and 600 mg.
Warnings and precautions
Serious Warnings and Precautions
- Blood: Although infrequently reported, serious adverse effects affecting blood cell counts have been observed during the use of APO-OXCARBAZEPINE. Other side effects include: low white blood cell count, bone marrow depression and hepatitis. Close clinical and frequent laboratory supervision with your doctor should be maintained throughout treatment with APO-OXCARBAZEPINE in order to detect as early as possible any possible signs of a blood disorder. Your doctor should discontinue APO-OXCARBAZEPINE, if there is significant evidence of a bone marrow depression.
- Skin: Serious and sometimes fatal skin reactions known as Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome ( SJS), have been reported with APO-OXCARBAZEPINE. Other serious skin reactions such as Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Acute Generalized Exanthematous Pustulosis (AGEP) and maculopapular rash have also been reported. Although very rare, serious forms of DRESS and AGEP may also lead to death. Since some cases of these skin reactions have been genetically linked, your doctor may recommend a blood test to determine whether you belong to an at-risk population.
- Contact your doctor immediately if you are developing a rash or any serious skin reactions such as red skin, blistering of the lips, eyes or mouth, and skin peeling accompanied by fever. Your doctor will determine if it is indeed drugrelated, and discontinue APO-OXCARBAZEPINE in this case.
Important points you must tell your doctor before taking APO-OXCARBAZEPINE
- If you have ever shown unusual sensitivity (rash or any other signs of allergy) to carbamazepine or to any other drugs. If you have had an allergic reaction to carbamazepine you have a 25% to 30% chance of being allergic to APO-OXCARBAZEPINE.
- If you have a kidney disease.
- If you have a serious liver disease.
- If you are taking diuretics (medicines used to help the kidneys get rid of salt and water by increasing the amount of urine produced).
- If you have a heart disease with shortness of breath and swelling of the feet or legs due to fluid retention.
- If you know that your blood level of sodium is low.
- If you are pregnant, breast-feeding or planning to become pregnant (see ‘What special precautions should pregnant or breast-feeding women take?’).
- If you are taking other medicines (see INTERACTIONS WITH THIS MEDICATION: ‘Can you use APO-OXCARBAZEPINE if you are taking other medicines?’).
- If you have a history, or family history, of bone disease.
You should also tell your doctor if any of these statements were applicable at any time in the past.
If you are a woman taking a hormonal contraceptive (such as “the pill”), APO-OXCARBAZEPINE may render this contraceptive ineffective. Therefore, you should use either a different method of contraception or an additional nonhormonal method of contraception while you are taking APO-OXCARBAZEPINE. This should help to prevent an unwanted pregnancy. Tell your doctor at once if you get irregular vaginal bleeding or spotting. If you have any questions about this, check with your doctor or health professional.
Do not stop your treatment with APO-OXCARBAZEPINE without first checking with your doctor. To prevent sudden worsening of your seizure, do not discontinue your medicine abruptly.
If you have any further questions on the use of this medicine, ask your doctor.
Will APO-OXCARBAZEPINE affect your ability to drive or use machines?
It is important to discuss with your doctor if you can drive a vehicle or operate machines. APO-OXCARBAZEPINE may make you feel sleepy or dizzy, or may cause blurred vision, double vision, lack of muscle coordination or a depressed level of consciousness, especially at the beginning of treatment, and may affect your ability to operate machinery, including a vehicle.
What special precautions should pregnant or breastfeeding women take?
Tell your doctor if you are pregnant, breast-feeding, or planning to become pregnant. It is important to control epileptic seizures during pregnancy. However, there may be a risk to your baby if you take antiepileptic drugs during pregnancy. Your doctor will tell you the benefits and potential risks involved and help you to decide whether you should take APO-OXCARBAZEPINE.
Do not stop your treatment with APO-OXCARBAZEPINE during pregnancy without first checking with your doctor.
During pregnancy there can be a gradual decrease in the amount of the active ingredient in APO-OXCARBAZEPINE in your blood. As a precaution to check that the blood levels of the active ingredient are adequate for controlling your seizures, your doctor may recommend periodic blood testing throughout your pregnancy.
The active ingredient in APO-OXCARBAZEPINE passes into breast milk. This could cause side effects for breast-fed babies. Therefore, you should not use APO-OXCARBAZEPINE during breast- feeding.
Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or while you are breastfeeding.
Interactions with this medication
Can you use APO-OXCARBAZEPINE if you are taking other medicines?
Before taking any medicine at the same time as APO-OXCARBAZEPINE talk to your doctor or pharmacist. This applies to both prescription and non-prescription (over-the-counter) medicines because these might interact with APO-OXCARBAZEPINE and especially to:
- Hormonal contraceptives (such as the birth-control pill). (see WARNINGS AND PRECAUTIONS)
- Other antiepileptic drug (e.g. carbamazepine, phenobarbital, phenytoin).
- rifampicin
- Calcium antagonists (such as felodipine) (type of medicine used to treat high blood pressure).
- Medicines which reduce the level of sodium in your blood, e.g. diuretics (used to help the kidneys get rid of salt and water by increasing the amount of urine produced).
- Medicines which control your body’s immune system (such as cyclosporine).
What foods and drinks should be avoided?
Alcohol may increase the sedative effects (making you more sleepy) of APO-OXCARBAZEPINE. Avoid alcohol as much as possible and ask your doctor for advice.
Proper use of this medication
APO-OXCARBAZEPINE can be taken with or without food.
Usual dose
Take your medicine exactly as your doctor or pharmacist tells you.
APO-OXCARBAZEPINE should be taken twice a day, every day, at about the same time of day, unless the doctor tells you otherwise. Taking APO-OXCARBAZEPINE at the same time each day will have the best effect on controlling epilepsy. It will also help you to remember when to take APO-OXCARBAZEPINE.
The usual starting dose of APO-OXCARBAZEPINE for adults (including elderly patients) is 600 mg per day. Take one 300 mg tablet twice daily or two 150 mg tablets twice daily. This dosage may be gradually increased if necessary until the best results are obtained. This is usually achieved at a dose between 600 and 2400 mg per day.
If APO-OXCARBAZEPINE is being taken with another antiepileptic, best results may be obtained with a dose between 600 and 1200 mg per day. Your doctor will decide the best dose of APO-OXCARBAZEPINE if you are taking another antiepileptic.
The starting dose in patients with kidney disease (with impaired renal function) is half the usual starting dose.
The dosage for children will be calculated by your doctor and depends on your child’s weight. The starting dose is 8 to 10 mg/kg bodyweight per day given in two divided doses.
Your doctor will tell you how long your/your child’s treatment with APO-OXCARBAZEPINE will last. The duration of treatment is based on your/your child’s seizure type; and ongoing treatment for many years may be necessary to control the seizures. Do not change the dose or stop treatment without talking to your doctor.
Overdose
Missed Dose
If you have only forgotten one dose, take it as soon as you remember. However, if it is time for your next dose, do not take the missed dose. Just go back to your regular dosing timetable. Do not double the dose at any time.
If you have forgotten to take several doses, contact your doctor.
Side effects and what to do about them
The most common side-effects may include:
- Fatigue, sleepiness, dizziness, unsteadiness,
- Headache
- Nausea, vomiting, abdominal pain, diarrhea, constipation
- Double vision, uncontrolled eye movement, blurred vision
- Anxiety, nervousness, feeling of depression, mood swing, memory problems, difficulty concentrating, apathy (feeling indifferent/loss of interest), agitation, confusion
- Trembling, problems with muscle coordination, weakness
- Acne, hair loss.
- 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.
If any of the side effects affects you severely, or if you notice any side effect not listed in this leaflet, please tell you doctor or pharmacist.
| Symptom / effect | Talk with your doctor or pharmacist right away Only if severe | Talk with your doctor or pharmacist right away In all cases | Seek immediate emergency medical treatment |
|---|---|---|---|
| Uncommon | |||
| Decreased White Blood Cells: frequent infections, fever, sore throat, 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 | ✔ | ||
| Hypersensitivity reactions: skin rash, fever, swollen glands (swelling of the lymph nodes), and pain in the muscles and joints | ✔ | ||
| Serious skin reaction: blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals | ✔ | ||
| Systemic lupus erythematosus: red blotchy rash mainly on face which may be accompanied by fatigue, fever, nausea, loss of appetite | ✔ | ||
| Decrease blood cells: tiredness, shortness of breath when exercising, looking pale, headache, chills, dizziness, frequent infections leading to fever, sore throat, mouth ulcers | ✔ | ||
| Decrease blood platelets: bleeding or bruising more easily than normal, nose bleeds, reddish or purplish patches, or unexplained blotches on the skin | ✔ | ||
| Low sodium level in blood: Lack of energy, confusion, muscular twitching or significant worsening of convulsions | ✔ | ||
| Hepatitis: nausea, loss of appetite, vomiting combined with itching, upper stomach (abdominal) pain, yellowing of the skin or eyes | ✔ | ||
| Flu-like symptoms accompanied with liver disorders | ✔ | ||
| Underactive thyroid gland: weight gain, tiredness, hair loss, muscle weakness, feeling cold | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APO-OXCARBAZEPINE, contact your doctor or pharmacist.
How to store
The tablets should be stored at room temperature (15°C to 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 the reach and sight of children.
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 (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) 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.
More information
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 this patient medication information by visiting the Health Canada website (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.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last revised: November 13, 2018