Patient Medication Information: uses, side effects, how to take - Auro-Carbamazepine
Serious warnings and precautions box
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What Auro-Carbamazepine is used for:
Auro-Carbamazepine is used to treat:
- Epilepsy: Auro-Carbamazepine can be use alone or with other anticonvulsant drugs to reduce the number of seizures in adults and children 6 years of age or older.
- Trigeminal Neuralgia: Auro-Carbamazepine relieve the pain of trigeminal neuralgia in adults. Auro-Carbamazepine should not be used to relieve trivial pain in the face or headaches.
- Mania and Bipolar Disorders: Auro-Carbamazepine can be used alone or together with the medicine lithium to treat acute mania or bipolar disorder in adults. Auro-Carbamazepine can be used if you are unable to take other antimanic drugs or do not respond to them.
How Auro-Carbamazepine works:
Auro-Carbamazepine belongs to the family of medicines called antiepileptics for treating epilepsy. Auro-Carbamazepine are also used for treating the pain of trigeminal neuralgia and for treating mania.
The ingredients in Auro-Carbamazepine are:
Medicinal ingredient: Carbamazepine.
Non-medicinal ingredients: Cellulose microcrystalline, croscarmellose sodium, hypromellose, magnesium stearate and silica colloidal anhydrous.
Auro-Carbamazepine comes in the following dosage form(s):
Tablets; 200 mg
Do not use Auro-Carbamazepine if:
- you are allergic to carbamazepine, tricyclic drugs (such as amitriptyline, trimipramine, and imipramine), or any of the other ingredients of Auro-Carbamazepine.
- you have severe heart disease (including heart block).
- you have or have had liver disease.
- you have a history of bone marrow depression.
- you have or have had serious blood problems.
- you have a history of hepatic porphyria (unable to make heme, a component needed for blood formation and liver function).
- you are also taking, or have recently taken, medicines belonging to a group of antidepressants called monoamine-oxidase inhibitors (MAOIs). You should not take Auro-Carbamazepine within 14 days of taking a MAOI.
- you are also taking itraconazole or voriconazole (medicines used to treat fungal infections).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Auro-Carbamazepine. Talk about any health conditions or problems you may have, including if you:
- have or have had any liver, kidney, heart, or thyroid problems.
- have kidney problems associated with low levels of sodium in the blood.
- have kidney problems and you are also taking certain medicines that lower sodium blood levels (diuretics or “water pills” such as hydrochlorothiazide, furosemide).
- have any blood problems (including those caused by other medicines).
- have ever shown any unusual sensitivity (rash or other signs of allergy such as swelling of lips, eyelids, face, throat, mouth, or sudden breathing problems) to oxcarbazepine or other drugs used to treat your condition. It is important to note that if you are allergic to Auro-Carbamazepine (carbamazepine), there is an approximately 1 in 4 (25%) chance that you could also have an allergic reaction to oxcarbazepine.
- get irregular vaginal bleeding or spotting.
- have increased pressure in the eye (glaucoma).
- have difficulty passing urine (urinary retention).
Other warnings you should know about:
Mental Health Problems and Thoughts of Suicide: Tell your healthcare professional if you have any mental health problems, including psychosis, agitation or confusion (especially in the elderly) or if you have ever had thoughts of harming or killing yourself. A small number of patients taking antiepileptic drugs, including Auro-Carbamazepine, have had suicidal thoughts or behaviours. This might be more likely to happen when you first start taking Auro-Carbamazepine or when your dose is changed. Get immediate medical help if you, or someone you are caring for, has thoughts of suicide or suicidal behaviours.
Increase in Seizures: If you are taking Auro-Carbamazepine for epilepsy and you experience an increase in the number of seizures you are having, contact your healthcare professional immediately.
Falls: Auro-Carbamazepine may cause lack of coordination, dizziness, drowsiness, low blood pressure, confusion and sedation which may lead to falls, fractures and other injuries. This risk can be increased if you have other diseases, medical conditions or take other medications. Talk to your healthcare professional if you have questions about this.
Bone Mineral Density: Talk to your healthcare professional if you have, or have a family history, of bone disease or if you have taken antiepileptics (such as phenobarbital, phenytoin, primidone, oxcarbazepine, lamotrigine, sodium valproate and/or carbamazepine) for a prolonged period of time. Long-term use of antiepileptics, including Auro-Carbamazepine can lead to weakened or brittle bones.
Eye Problems: Auro-Carbamazepine can cause eye problems. Periodic eye exams are recommended while you are taking Auro-Carbamazepine.
Alcohol: You should not drink alcohol while taking Auro-Carbamazepine. Talk to your healthcare professional about your alcohol consumptions and if you have a history of alcohol dependence.
Fertility, Birth Control, Pregnancy and Breastfeeding:
Female Patients:
- Avoid becoming pregnant while taking Auro-Carbamazepine. Auro-Carbamazepine may harm your unborn baby. Babies born to mothers who took Auro-Carbamazepine during pregnancy are at risk of serious side effects.
- Tell your healthcare professional immediately if you become pregnant or think you might be pregnant.
- Use highly effective birth control if you can get pregnant while taking Auro-Carbamazepine and for 2 weeks after your last dose.
- If you are using oral hormonal birth control (such as “The Pill”) it might not work while you are taking Auro-Carbamazepine. Taking Auro-Carbamazepine while on oral birth control might also cause irregular periods. You must use a different or an additional non-hormonal method of birth control while you are taking Auro-Carbamazepine. Talk to your healthcare professional about the birth control options that are right for you.
- Carbamazepine passes into breastmilk. You should not breastfeed while you are taking Auro-Carbamazepine as Auro-Carbamazepine can cause serious side effects in your baby.
Male Patients:
- Auro-Carbamazepine may affect your fertility. It may also cause abnormal sperm production. This means it may be difficult for you to father a child. Talk to your healthcare professional if you have questions about this.
Driving and Using Machines: Auro-Carbamazepine can cause dizziness, drowsiness, sleepiness, blurred or double vision and can affect your muscular coordination and your alertness. Do not drive or use machines until you know how you respond to Auro-Carbamazepine.
Blood Tests: Auro-Carbamazepine can cause abnormal blood test results. Your healthcare professional will perform blood tests before you start taking Auro--Carbamazepine and regularly during your treatment, and will interpret the results.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
This is particularly important for Auro-Carbamazepine, since many other medicines interact with them. Your healthcare professional may need to change in your dose or, sometimes, to stop one of these other medicines.
Serious drug interactions:
Serious drug interactions with Auro-Carbamazepine include:
- monoamine oxidase inhibitors (MAOIs). Auro-Carbamazepine must not be taken within 14 days of MAOIs, a group of antidepressant medicines.
- itraconazole and voriconazole, medicines used to treat fungal infections. Auro-Carbamazepine must not be taken with itraconazole or voriconazole.
The following may also interact with Auro-Carbamazepine:
- Medicines used to treat pain and reduce inflammation such as; buprenorphine, methadone, paracetamol (acetaminophen), phenazone (antipyrine), tramadol, dextropropoxyphene, and ibuprofen.
- Medicines used to treat bacterial infections such as; doxycycline, rifabutin, erythromycin, troleandomycin, josamycin, clarithromycin, telithromycin, and ciprofloxacin.
- Medicines used to prevent blood clots such as; warfarin, phenprocoumon, dicoumarol, acenocoumarol, rivaroxaban, dabigatran, apixaban, edoxaban, and ticlopidine.
- Antidepressants used to treat depression such as; bupropion, citalopram, mianserin, nefadozone, sertraline, trazodone, tricyclic antidepressants (e.g. imipramine, amitriptyline, nortryptyline, and clomipramine), desipramine, fluoxetine, fluvoxamine, paroxetine, and viloxazine.
- Medicines used to prevent seizures such as; oxcarbazepine, clobazam, clonazepam, ethosuximide, methsuximide, primidone, valproic acid, felbamate, lamotrigine, eslicarbazepine, zonisamide tiagabine, topiramate, phenytoin, stiripentol, vigabatrin, valpromide, phenobarbital, phensuximide, progabide, levetiracetam, and brivaracetam.
- Medicines used to treat fungal infections such as; itraconazole, ketoconazole, fluconazole, voriconazole, and caspofungin.
- Medicines used to treat parasites such as; praziquantel, and albendazole.
- Medicines used to treat tuberculosis infection such as; isoniazid and rifampicin.
- Medicines used to treat cancer such as; imatinib, irinotecan, gefitinib, cyclophosphamide, lapatinib, temsirolimus, cisplatin, and doxorubicin.
- Medicines used to treat mental health problems such as; clozapine, haloperidol, bromperidol, olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, paliperidone, loxapine, lithium, and metoclopramide.
- Medicines used to treat HIV infection and AIDS such as; indinavir, ritonavir, saquinavir, and delavirdine.
- Medicines used to treat anxiety such as; alprazolam and midazolam.
- Medicines used to treat heart problems such as; felodipine, digoxin, disopyramide, quinidine, propranolol, simvastatin, atorvastatin, lovastatin, ivabradine, verapamil, and diltiazem.
- Medicines used to treat stomach problems such as; cimetidine, and omeprazole.
- Medicines used to treat inflammation called corticosteroids such as; prednisolone, and dexamethasone.
- Medicines used to suppress the immune system such as; cyclosporin, everolimus, tacrolimus, and sirolimus.
- Medicines used to treat breathing problems such as; theophylline, and aminophylline.
- Diuretics or “water pills” such as; hydrochlorothiazide, and furosemide.
- Muscle relaxants such as; oxybutynin, dantrolene, and pancuronium.
- Terfenadine, a medicine used to treat allergies.
- Acetazolamide, a medicine used to treat glaucoma.
- Aprepitant, a medicine used to prevent nausea and vomiting.
- Danazol, a medicine used to treat endometriosis and other conditions.
- Isotretinoin, a medicine used to treat skin conditions such as acne.
- Levothyroxine, a medicine used to treat thyroid problems.
- Tadalafil, a medicine used to treat erectile dysfunction.
- Hormonal birth control including estrogens and progesterones.
- St. John’s wort, an herbal medicine used to treat depression.
- Vitamin B-3 such as; nicotinamide and niacinamide.
- Alcohol.
- Grapefruit juice.
How to take Auro-Carbamazepine:
- Always take Auro-Carbamazepine exactly as your healthcare professional has told you to. Your healthcare professional will decide on the dose that is right for you. Never increase or decrease your dose without talking to your healthcare professional.
- Do not stop taking Auro-Carbamazepine without talking to your healthcare professional. Your healthcare professional will tell you if and when you can stop taking this medicine.
- Auro-Carbamazepine should be taken in 2-4 divided doses daily, with meals whenever possible.
- Avoid alcohol consumption when taking Auro-Carbamazepine.
- Do not drink grapefruit juice or eat grapefruit since this can increase the effect of Auro-Carbamazepine. Other juices, like orange juice or apple juice, do not have this effect.
Usual dose:
Epilepsy:
Adults and Children Over 12 Years of Age:
Initial dose: 100 to 200 mg once or twice a day.
Usual dose: 800 to 1200 mg daily in divided doses.
Children 6-12 Years of Age
Initial dose: 100 mg a day in 2 to 4 divided doses.
The dose will be increased gradually by your healthcare professional until the right dose is found.
Trigeminal Neuralgia:
Adults:
Initial dose: 100 mg twice a day.
Usual dose: 200 to 800 mg daily in divided doses.
Maximum dose: 1200 mg a day in divided doses.
Mania and Bipolar Disorders:
Adults:
Initial dose: 200 to 400 mg daily in divided doses.
Usual dose: 400 to 1200 mg daily in divided doses.
Maximum dose: 1600 mg a day in divided doses.
Overdose:
If you think you, or a person you are caring for, have taken too much Auro-Carbamazepine, 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 miss a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and return to your regular dosing schedule. Do not take a double dose to make up for the missed dose.
Possible side effects from using Auro-Carbamazepine:
These are not all the possible side effects you may have when taking Auro-Carbamazepine. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- purple or reddish-purple bumps that may be itchy;
- trembling, uncontrolled body movements, muscle spasm, loss of muscle coordination, weakness;
- agitation or hostility (especially in the elderly);
- depression with restlessness;
- nervousness or other mood or mental changes;
- changes in behaviour, confusion, headache, memory loss;
- blurred vision, double vision, itching with redness and swelling of the eye (conjunctivitis), uncontrolled eye movements;
- difficulty speaking or slurred speech, taste disturbances, dry mouth, red and sore tongue, mouth sores;
- ringing or other unexplained sounds in the ears, decreased hearing;
- numbness, tingling in hands and feet;
- unusual secretion of breast milk, breast enlargement in men, sexual disturbances (erectile dysfunction), male infertility;
- increased sensitivity of the skin to sun, changes in skin colouring, acne, increased sweating ;
- reactivation of herpes virus infection (can be serious when the immune system is depressed);
- complete loss of the nails, loss of hair, excessive body and facial hair;
- vomiting, nausea, loss of appetite, constipation, diarrhea, abdominal pain;
- dizziness, sleepiness, unsteadiness, drowsiness, fatigue;
- weight gain;
- aching joints or muscles;
- experience a fall due to dizziness, drowsiness, decrease in blood pressure, confusion;
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very common | |||
| Decreased White Blood Cells: fever, sore throat, rash, ulcers in the mouth, swollen glands, or more easily getting infections. | √ | ||
| Suicidal Thoughts or Actions: thoughts, plans and actions taken for the purpose of killing or harming yourself. | √ | ||
| Common | |||
| Edema: unusual swelling of the ankles, feet or lower legs. | √ | ||
| Rare | |||
| Hallucination: see or hear things that are not there. | √ | ||
| High Blood Pressure or Low Blood Pressure: dizziness, fainting, light-headedness. | √ | ||
Systemic Lupus Erythematosus (autoimmune disease that occurs when your body’s immune system attacks your own tissues and organs): red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite. | √ | ||
| Very rare | |||
| Angioedema and 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. | √ | ||
| Bone marrow depression (lack of all blood cells): tiredness, headache, being short of breath when exercising, dizziness, looking pale, frequent infections leading to fever, chills, sore throat or mouth ulcers, bleeding or bruising more easily than normal, nose bleeds. | √ | ||
| Circulatory Collapse: the body is unable to circulate blood to the organs. This is very serious and can lead to death. | √ | ||
| Disturbed consciousness, fainting. | √ | ||
| Glaucoma: increased pressure or pain in the eyes. | √ | ||
| Heart Problems: irregular heartbeat, chest pain, fast or unusually slow heartbeat, trouble breathing. | √ | ||
| Hyponatremia (low sodium in the blood): lethargy, confusion, muscular twitching or significant worsening of convulsions. | √ | ||
| Kidney Problems: severely decreased urine output, blood in the urine, frequent urination. | √ | ||
| Liver Problems: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite. | √ | ||
| Meningitis: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. | √ | ||
| Neuroleptic Malignant Syndrome: muscular stiffness, high fever, altered consciousness, high blood pressure, excessive salivation. | √ | ||
| Pancreatitis (inflammation of the pancreas): severe upper abdominal pain, vomiting, loss of appetite. | √ | ||
| Porphyria (a disorder that affects how the blood functions): darkening of urine, severe abdominal pain, excessive sweating, vomiting, anxiety. | √ | ||
Serious Skin Reactions: itchy skin rash, redness, blistering of the lips, eyes or mouth, reddish or purplish, round or oval patches with blisters, skin peeling, fever, chills, headache, cough, body aches, swollen lymph nodes, joint pain, flu-like feeling, yellowing of the skin or eyes, shortness of breath, dry cough, chest pain, chest discomfort, feeling thirsty, urinating less often. | √ | ||
| Thromboembolism (blood clot): swelling, pain and redness in an arm or a leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations. | √ | ||
Thrombophlebitis: swelling and redness along a vein which is extremely tender or painful when touched. | √ | ||
| Unknown | |||
| Inflammation of the colon: diarrhea, abdominal pain, fever. | √ | ||
| Fixed drug eruption (FDE): a demarcated skin patch (red, itchy, or blistered) that reappears in the same place as a previous reaction and may leave a dark mark. Repeated use of the medication can cause this to become a more widespread, and life-threatening serious skin reaction called generalized bullous fixed drug reaction (GBFDE). | √ | ||
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:
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. |
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Storage:
- Store at 15-25°C, protect from humidity.
- Keep Auro-Carbamazepine out of reach and sight of children.
If you want more information about Auro-Carbamazepine:
- 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 (http://www.auropharma.ca) or by calling 1-855-648-6681.
Date of Authorization: SEP. 3, 2026