Teva-Carbamazepine: Uses, Side Effects and Dosage

Serious Warnings and Precautions

• Blood: Serious side effects affecting blood cell counts have been reported in patients taking TEVA-CARBAMAZEPINE. These side effects are very rare but have been fatal. Other side effects that may happen with taking TEVA-CARBAMAZEPINE include: low white blood cell count, bone marrow depression and liver problems, including liver failure. Your healthcare professional will do blood tests and frequent exams while you are taking TEVA-CARBAMAZEPINE to watch for signs of these serious side effects. If you experience any of the following symptoms, contact your healthcare professional immediately:

  • signs of infections (fever, sore throat, rash, ulcers in the mouth, swollen glands)
  • signs of liver problems (yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite)
  • weakness, fatigue
  • easy bruising, bleeding of the nose, gums or mouth, tiny red spots on the skin
  • shortness of breath
  • pale skin, lips and nail beds

• Skin: Serious and sometimes fatal skin reactions known as Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), have been reported in patients taking TEVA-CARBAMAZEPINE. Other serious skin reactions such as Drug Reaction 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. Some cases of these skin reactions have been genetically linked. Your healthcare professional may recommend a blood test to see if you are at risk before you start taking TEVA-CARBAMAZEPINE. If you experience any of the following symptoms, contact your healthcare professional immediately:

  • a rash or any serious skin reactions such as red skin, blistering of the lips, eyes or mouth, and skin peeling accompanied by fever
  • swollen glands
  • joint pain
  • enlargement of the liver and/or the spleen with symptoms such as flu-like feeling, yellowing of the skin or eyes
  • problems related to the lungs, kidneys, pancreas, heart, bone marrow, thymus, and colon with symptoms such as shortness of breath, dry cough, chest pain or discomfort, feeling thirsty, urinating less often
• Cancer: Taking TEVA-CARBAMAZEPINE may increase your risk of developing certain cancers. Before taking TEVA-CARBAMAZEPINE, discuss the potential benefits and possible risks of this treatment with your healthcare professional.

What is TEVA-CARBAMAZEPINE used for?

TEVA-CARBAMAZEPINE is used to treat:

• Epilepsy: TEVA-CARBAMAZEPINE can be use alone or with other anticonvulsant drugs to reduce the number of seizures you experience.
• Trigeminal Neuralgia: TEVA-CARBAMAZEPINE relieves the pain of trigeminal neuralgia. TEVA-CARBAMAZEPINE should not be used to relieve trivial pain in the face or headaches.
• Mania and Bipolar Disorders: TEVA-CARBAMAZEPINE can be used alone or together with the medicine lithium to treat acute mania or bipolar disorder. TEVA-CARBAMAZEPINE can be used if you are unable to take other antimanic drugs or do not respond to them.

How does TEVA-CARBAMAZEPINE work?

TEVA-CARBAMAZEPINE belongs to the family of medicines called anticonvulsants for treating epilepsy. TEVA-CARBAMAZEPINE is also used for treating the pain of trigeminal neuralgia and for treating mania.

What are the ingredients in TEVA-CARBAMAZEPINE?

Medicinal ingredient: carbamazepine

Non-medicinal ingredients: magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulphate and sodium starch glycolate.

TEVA-CARBAMAZEPINE comes in the following dosage forms:

Tablets; 200 mg

Do not use TEVA-CARBAMAZEPINE if you:

• are allergic (hypersensitive) to carbamazepine, tricyclic drugs (such as amitriptyline, trimipramine, imipramine), or to any of the other ingredients of TEVA-CARBAMAZEPINE (See What the non-medicinal ingredients are).
• have severe heart disease (heart block).
• have liver disease.
• have a history of bone marrow depression.
• have had serious blood illnesses in the past.
• have a disturbance in the production of porphyrin, a pigment important for liver function and blood formation (also called hepatic porphyria).
• are also taking, or have recently taken, medicines belonging to a special group of antidepressants called monoamine-oxidase inhibitors (MAOIs). You should not take TEVA-CARBAMAZEPINE within 14 days of taking a MAOI.
• are also taking the drugs 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 TEVA-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 or if you 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 disorders (including those caused by other medicines).
• are taking delavirdine, a medicine used to treat HIV-1 infection.
• have ever shown any unusual sensitivity (rash or other signs of allergy) to oxcarbazepine or other drugs used to treat your condition. It is important to note that if you are allergic to TEVA-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 TEVA-CARBAMAZEPINE, have had suicidal thoughts or behaviours. This might be more likely to happen when you first start taking TEVA-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 TEVA-CARBAMAZEPINE for epilepsy and you experience an increase in the number of seizures you are having, contact your healthcare professional immediately.

Falls: TEVA-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, lamotrignine, sodium valproate and/or carbamazepine) for a prolonged period of time. Long-term use of antiepileptics, including TEVA CARBAMAZEPINE, can lead to weakened or brittle bones.

Eye Problems: TEVA-CARBAMAZEPINE can cause eye problems. Periodic eye exams are recommended while you are taking TEVA CARBAMAZEPINE.

Alcohol: You should not drink alcohol while taking TEVA 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 TEVA CARBAMAZEPINE. This drug may harm your unborn baby. Babies born to mothers who took TEVA 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 TEVA-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 TEVA-CARBAMAZEPINE. Taking TEVA-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 TEVA-CARBAMAZEPINE. Talk to your healthcare professional about the birth control options that are right for you.
  • TEVA-CARBAMAZEPINE pass into breastmilk. You should not breastfeed while you are taking TEVA-CARBAMAZEPINE as they can cause serious side effects in your baby.

• Male Patients:

  • TEVA-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: TEVA-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 TEVA-CARBAMAZEPINE.

Blood Tests: TEVA-CARBAMAZEPINE can cause abnormal blood test results. Your healthcare professional will perform blood tests before you start taking TEVA-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 TEVA-CARBAMAZEPINE, since many other medicines interact with them. You may need a change in your dose or, sometimes, to stop one of these other medicines.

Serious Drug Interactions

• TEVA-CARBAMAZEPINE must not be taken within 14 days of monoamine oxidase (MAO) inhibitors, a special group of antidepressant medicines.
• TEVA-CARBAMAZEPINE must not be taken with itraconazole and voriconazole, medicines used to treat fungal infections.

The following may interact with TEVA-CARBAMAZEPINE:

• Medicines used to treat pain and reduce inflammation such as; buprenorphine, methadone, paracetamol (acetaminophen), phenazone (antipyrine), tramadol, dextropropoxyphene, ibuprofen
• Medicines used to treat bacterial infections such as; doxycycline, rifabutin, erythromycin, troleandomycin, josamycin, clarithromycin, telithromycin, ciprofloxacine
• Medicines used to prevent blood clots such as; warfarin, phenprocoumon, dicoumarol, acenocoumarol, rivaroxaban, dabigatran, apixaban, edoxaban, ticlopidine
• Antidepressants such as; bupropion, citalopram, mianserin, nefadozone, sertraline, trazodone, tricyclic antidepressants (e.g. imipramine, amitriptyline, nortryptyline, clomipramine), desipramine, fluoxetine, fluvoxamine, paroxetine, viloxazine
• Antihistamines used to treat allergies such as; terfenadine, loratadine
• 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, brivaracetam
• Medicines used to treat fungal infections such as; itraconazole, ketoconazole, fluconazole, voriconazole, caspofungin
• Medicines used to treat parasites such as; praziquantel, albendazole
• Medicines used to treat tuberculosis infection such as; isoniazid, rifampicin
• Medicines used to treat cancer such as; imatinib, irinotecan, gefitinib, cyclophosphamide, lapatinib, temsirolimus, cisplatin, doxorubicin
• Medicines used to treat mental health problems such as; clozapine, haloperidol, bromperidol, olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, paliperidone, loxapine, lithium, metoclopramide
• Medicines used to treat HIV infection and AIDS such as; indinavir, ritonavir, saquinavir, delavirdine
• Medicines used to treat anxiety such as; alprazolam, midazolam
• Medicines used to treat heart problems such as; felodipine, digoxin, disopyramide, quinidine, propranolol, simvastatin, atorvastatin, lovastatin, ivabradine, verapamil, diltiazem
• Medicines used to treat stomach problems such as; cimetidine, omeprazole
• Medicines used to treat inflammation called corticosteroids such as; prednisolone, dexamethasone
• Medicines used to suppress the immune system such as; cyclosporin, everolimus, tacrolimus, sirolimus
• Medicines used to treat breathing problems such as; theophylline, aminophylline
• Diuretics or “water pills” such as; hydrochlorothiazide, furosemide
• Muscle relaxants such as; oxybutynin, dantrolene, 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 medicines 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, niacinamide.
• Avoid alcohol consumption when taking TEVA-CARBAMAZEPINE.
• Do not drink grapefruit juice or eat grapefruit since this can increase the effect of TEVA- CARBAMAZEPINE. Other juices, like orange juice or apple juice, do not have this effect.

How to take TEVA-CARBAMAZEPINE:

• Always take TEVA-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 TEVA-CARBAMAZEPINE without talking to your healthcare professional. Your healthcare professional will tell you if and when you can stop taking this medicine.
• TEVA-CARBAMAZEPINE should be taken in 2-4 divided doses daily, with meals whenever possible.

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, TEVA-CARBAMAZEPINE, 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 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 forgotten dose.

What are possible side effects from using TEVA-CARBAMAZEPINE?

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

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

  • (https://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.

Storage:

• Store between 15°C and 30°C
• Protect from humidity, such as in bathrooms where you shower often.
• Keep out of reach and sight of children.

If you want more information about TEVA-CARBAMAZEPINE:

• 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/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.

Last revised: SEP 12, 2025