Taro-Carbamazepine: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is TARO-CARBAMAZEPINE used for?

TARO-CARBAMAZEPINE is used in adults to treat:

• Epilepsy: TARO-CARBAMAZEPINE can be use alone or with other anticonvulsant drugs to reduce the number of seizures you experience.

• Trigeminal Neuralgia: TARO-CARBAMAZEPINE relieves the pain of trigeminal neuralgia.

  TARO-CARBAMAZEPINE should not be used to relieve trivial pain in the face or headaches.

• Mania and Bipolar Disorders: TARO- CARBAMAZEPINE can be used alone or together with the medicine lithium to treat acute mania or bipolar disorder. TARO-CARBAMAZEPINE can be used if you are unable to take other antimanic drugs or do not respond to them.

How does TARO-CARBAMAZEPINE work?

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

What are the ingredients in TARO-CARBAMAZEPINE?

Medicinal ingredients: Carbamazepine.

Non-medicinal ingredients:

TARO-CARBAMAZEPINE Tablets 200 mg: Carboxymethylcellulose Sodium, Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose.

TARO-CARBAMAZEPINE Chewable Tablets 100 mg and 200 mg: Croscarmellose Sodium, Diethyl Phthalate, Eudragit RS 30D, FD & C Red No.40 Lake, Magnesium Stearate, Microcrystalline Cellulose, Natural Cherry Flavour, Pregelatinized Starch, Sorbitol.

TARO-CARBAMAZEPINE CR 200 mg and 400 mg Tablets: Diethyl Phthalate, Eudragit RS30D, Lactose Monohydrate, Magnesium Stearate, Maize Starch, Microcrystalline Cellulose, Sodium Starch Glycolate.

TARO-CARBAMAZEPINE Suspension 100 mg/5 mL: Citric Acid, FD&C Yellow # 6, Orange Flavour, Poloxamer 188, Potassium Sorbate, Propylene Glycol, Purified Water, Sucrose, Sorbitol Solution, Xanthan Gum.

TARO-CARBAMAZEPINE comes in the following dosage forms:

• Tablets containing 200 mg carbamazepine.
• CR tablets (controlled-release) containing 200 mg or 400 mg carbamazepine.
• Chewable tablets containing 100 mg or 200 mg carbamazepine.
• Oral suspension: 5 mL (1 measure) containing 100 mg carbamazepine.

Do not use TARO-CARBAMAZEPINE if you:

• are allergic (hypersensitive) to carbamazepine, tricyclic drugs (such as amitriptyline, trimipramine, imipramine), or to any of the other ingredients of TARO-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 ofporphyrin, 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 TARO-CARBAMAZEPINE within 14 days of taking a MAOI.
• are also taking the drugs itraconazole or voriconazole (Vfend) medicines used to treat fungal infections.
• have a rare hereditary problem of fructose intolerance as TARO-CARBAMAZEPINE Chewable Tablets and Suspension contain sorbitol.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TARO-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

  TARO-CARBAMAZEPINE there is an approximately 1 in 4 (25%) chance that you could also have an allergic reaction to oxcarbazepine (TRILEPTAL^®).

• 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 TARO-CARBAMAZAPINE have had suicidal thoughts or behavior. This might be more likely to happen when you first start taking TARO-CARBAMAZAPINE 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 TARO-CARBAMAZAPINE for epilepsy and you experience an increase in the number of seizures you are having, contact your healthcare professional immediately.
• Falls: TARO-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 TARO-CARBAMAZEPINE, can lead to weakened or brittle bones.
• Eye Problems: TARO-CARBAMAZEPINE can cause eye problems. Periodic eye examinations are recommended while taking TARO-CARBAMAZEPINE.

• Alcohol: You should not drink alcohol while taking TARO-CARBAMAZEPINE. Talk to your healthcare professional about your alcohol consumptions and if you have a history of alcohol dependence.

TARO-CARBAMAZEPINE Chewable Tablets and Suspension contain sorbitol which may cause stomach upset and diarrhea.

Fertility, Birth Control, Pregnancy and Breastfeeding:

• Female Patients:

  • Avoid becoming pregnant while taking TARO-CARBAMAZEPINE. It may harm your unborn baby. Babies born to mothers who took TARO-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

    TARO-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 TARO-CARBAMAZEPINE. Taking TARO-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

    TARO-CARBAMAZEPINE. Talk to your healthcare professional about the birth control options that are right for you.

  • TARO-CARBAMAZEPINE pass into breastmilk. You should not breastfeed while you are taking TARO-CARBAMAZEPINE as it can cause serious side effects in your baby.

• Male Patients:

  • TARO-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: TARO-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 TARO-CARBAMAZEPINE.

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

The following may interact with TARO-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
• 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, zisprasidone, 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
• 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 TARO-CARBAMAZEPINE.

• Do not drink grapefruit juice or eat grapefruit since this can increase the effect of

  TARO-CARBAMAZEPINE. Other juices, like orange juice or apple juice, do not have this effect.

PROPER USE OF THIS M

How to take TARO-CARBAMAZEPINE:

• Always take TARO-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 TARO-CARBAMAZEPINE without talking to your healthcare professional. Your healthcare professional will tell you if and when you can stop taking this medicine.
• TARO-CARBAMAZEPINE Tablets, Chewable Tablets and Suspension should be taken in 2-4 divided doses daily, with meals whenever possible.
• TARO-CARBAMAZEPINE CR tablets should be swallowed whole with a little liquid during or after a meal. Do not crush or chew TARO-CARBAMAZEPINE CR tablets.
• Shake TARO-CARBAMAZEPINE suspension well before you take it or else you may not receive the correct dose.

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 does 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:

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 double the dose to make up for the forgotten dose.

What are possible side effects from using TARO-CARBAMAZEPINE ?

These are not all the possible side affects you may have when taking TARO-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

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

Storage:

• Taro-Carbamazepine Tablets: 25°C (15°C- 30°C) Protect from moisture and light.
• Taro-Carbamazepine CR Tablets: Store at 15°C - 25°C, protect from humidity.
• Taro-Carbamazepine Chewable Tablets: Store at room temperature (15°C -30°C). Protect from humidity and light.
• Taro-Carbamazepine Suspension: Store in tightly closed container at room temperature (15°C -30°C). Protect from humidity and light. Discard 2 months after opening.

Keep out of reach and sight of children.

If you want more information about TARO-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 (www.taro.ca), or by calling 1-800-268-1975.

130 East Drive, Brampton, Ontario L6T 1C1

TARO is a registered trademark of Taro Pharmaceuticals Inc.

Last revised: March 3, 2022.