Taro-Carbamazepine CR: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TARO-CARBAMAZEPINE has been prescribed for you by your doctor :

• to reduce your number of seizures;
• to relieve the pain of trigeminal neuralgia;
• to treat your acute mania or bipolar disorder.

What it does:

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.

If you have any questions about how TARO-CARBAMAZEPINE works or why this medicine has been prescribed to you, ask your doctor.

When it should not be used:

You should not use TARO-CARBAMAZEPINE if:

• You are allergic (hypersensitive) to carbamazepine

  or to any of the other ingredients of TARO-CARBAMAZEPINE (see What the non-medicinal ingredients are). If you think you may be allergic, ask your doctor for advice. Do not take TARO-CARBAMAZEPINE if you are allergic to other tricyclic drugs such as amitriptyline, trimipramine, imipramine.

• You have severe heart disease (heart block).
• You have liver disease
• You have a history of bone marrow depression
• You have had serious blood illnesses in the past

• You have a disturbance in the production of

  porphyrin, a pigment important for liver function and blood formation (also called hepatic porphyria);

  • You are also taking medicines belonging to a special group of antidepressants called monoamineoxidase inhibitors (MAOIs).
  • You are also taking the drugs itraconazole or voriconazole (Vfend) for treatment of an infection.
  • TARO-CARBAMAZEPINE should not be used to relieve trivial pain in the face or headaches.

  • TARO-CARBAMAZEPINE Chewable tablets and

    Suspension contain sorbitol which may cause stomach upset and diarrhea. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

If any of the above applies to you, tell your doctor before taking TARO-CARBAMAZEPINE.

What the medicinal ingredient is:

Carbamazepine.

What the non-medicinal ingredients are:

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

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

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

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.

What dosage forms it comes in:

TARO-CARBAMAZEPINE is available in the following 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.

WARNING AND PRECAUTIONS Serious Warnings and Precautions

• Blood: Although infrequently reported and

  very rarely fatal, serious adverse effects affecting the blood cell counts have been observed during the use of carbamazepine. Other side effects include: low white blood cell count, bone marrow depression, hepatitis and signs of liver failure such as jaundice (yellowing of the skin or eyes). Contact your doctor immediately if you are experiencing any of these symptoms. Close clinical and frequent laboratory supervision with your doctor should be maintained throughout treatment with TARO-CARBAMAZEPINE in order to detect as early as possible any possible signs of a blood disorder. Your doctor should discontinue TARO-CARBAMAZEPINE, 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 carbamazepine. 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. Some cases of these skin reactions have been genetically linked. Your doctor may recommend a blood test to determine if you belong to an at-risk population.

• Contact your doctor immediately if you are developing any combination of:

  • 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 lymph nodes
  • joint pain
  • enlargement of the liver and/or the spleen
  • problems related to the lungs, kidneys, pancreas, heart, bone marrow, thymus, and colon

Your doctor will determine if it is indeed drug-related, and discontinue TARO-CARBAMAZEPINE in this case.

• Cancer: Long-term toxicity studies in rats

  have indicated a possible cancer risk associated with carbamazepine. Before taking TARO-CARBAMAZEPINE, discuss with your doctor the potential benefits and possible risks of this treatment for you.

  BEFORE you use TARO-CARBAMAZEPINE talk to your doctor or pharmacist:

  • About your medical conditions, especially if you have or have had any liver, kidney, heart or thyroid disease or blood disorders (including those caused by other drugs).

  • If you have a history, or family history, of bone disease or have taken antiepileptics (such as phenobarbital, phenytoin, primidone, oxcarbazepine, lamotrignine, sodium valproate and/or

    carbamazepine) for a prolonged period of time.

  • If you are taking delavirdine, a medicine used to treat HIV-1 infection.

  • About any allergies you may have, especially if you 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^®).

  • If you are pregnant. Your doctor may recommend that you take folic acid before and during your pregnancy and vitamin K during the last weeks of pregnancy. Your doctor may also recommend that the newborn receive vitamin K and be observed for liver and gall bladder problems.

  • If you are pregnant or planning on becoming pregnant to discuss the potential risk of taking TARO-CARBAMAZEPINE during pregnancy since it may cause harm or abnormalities in the unborn child.
  • If you are a female of childbearing age you should use an effective method of contraception throughout your treatment and for 2 weeks after your last dose. If you are taking hormonal contraceptive (birth control medicine), TARO-CARBAMAZEPINE may render this contraceptive ineffective. Therefore, you should use a different or additional non-hormonal method of contraception while you are taking TARO-CARBAMAZEPINE. This should help to prevent an unwanted pregnancy.
  • If you get irregular vaginal bleeding or spotting.

  • If you are breast-feeding. TARO-

    CARBAMAZEPINE is known to pass into breast milk. You must discuss with your doctor the benefits of breastfeeding against any possible risks to the infant. If you decide to breastfeed, the baby must be

observed for liver and gall bladder problems, drowsiness, and allergic skin reactions.

• About any other medicines (prescription and

  nonprescription) you are taking.

• About your usual alcohol consumption.
• If you have increased pressure in the eye (glaucoma).

• If you have difficulty passing urine (urinary

  retention).

• If you were told by your physician that you suffer

  from mental problems, a mental disorder called psychosis that may be accompanied by confusion or agitation, or have thoughts about suicide.

If any of the following apply to you, tell your doctor.

• If an allergic reaction happens such as fever with

  lymph nodes swelling, rash or skin blistering, tell your doctor immediately or go to the emergency department at your nearest hospital. (see Side effects and what to do about them)

• If you experience an increase in the number of

  seizures, tell your doctor immediately.

• If you experience any side effects such as

  drowsiness, headache, unsteadiness on the feet, double vision, dizziness, nausea or vomiting, consult your doctor.

• If, at any time, you have thoughts of harming or

  killing yourself. A small number of people being treated with antiepileptic drugs have reported having such thoughts or behavior. Should this happen to you, or to those in your care if you are a caregiver or guardian, talk to your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.

• If you have kidney problems associated with low

  sodium blood level or if you have kidney problems and you are also taking certain medicines that lower sodium blood level (diuretics such as

  hydrochlorothiazide, furosemide).

• If you experience dizziness, drowsiness, decrease in

  blood pressure, confusion, due to TARO-CARBAMAZEPINE treatment, which may lead to falls.

TARO-CARBAMAZEPINE may affect male fertility or cause abnormal sperm.

Periodic eye examinations are recommended while taking TARO-CARBAMAZEPINE.

Do not drive a car or operate dangerous machinery until you are sure that TARO-CARBAMAZEPINE does not cause dizziness, drowsiness sleepiness, blurred or double vision, affect your muscular coordination or affect your alertness.

INTERACTIONS WITH YOUR MEDICATION

Tell your doctor or pharmacist if you are taking or have recently taken any prescription, non-prescription medicines or natural health products. It 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.

Irregularity of the menstrual period may occur in women taking hormonal contraceptives (birth control medicines) and TARO-CARBAMAZEPINE. The hormonal contraceptive may become less effective and you should use another different or additional non-hormonal contraceptive method.

• 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 MEDICATION

PROPER USE OF THIS MEDICATION

Usual dose:

Dosage should be individualised. It is very important that you take TARO-CARBAMAZEPINE exactly as your doctor instructed.

• Never increase or decrease the recommended dose of

  TARO-CARBAMAZEPINE you are taking unless your doctor tells you to.

• If you are taking TARO-CARBAMAZEPINE, do not suddenly stop taking it without first checking with your doctor. Your doctor 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 unchewed with a little liquid during or after a meal.
• Shake TARO-CARBAMAZEPINE suspension well before you take it or else you may not receive the correct dose.

Adults and Children Over 12 Years of Age Initial dose 100 to 200 mg once or twice a day. Your doctor will decide the best dosage for you. Always follow your doctor’s instructions.

For the treatment of trigeminal neuralgia, the maximum dose is 1200 mg a day.

Children 6-12 Years of Age

Initial dose 100 mg in divided doses on the first day. Your doctor will decide the best dosage for you. Always follow your doctor’s instructions.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose, take your TARO-

CARBAMAZEPINE as soon as possible. However, if the time is close to the next dose, do not take the missed dose and return to your regular dosing schedule. Do not double the dose to make up for the forgotten dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

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, alterations in

  skin pigmentation, 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

Long-term use of antiepileptics such as carbamazepine, phenobarbital, phenytoin, primidone, oxcarbazepine, lamotrigine and sodium valproate is associated with a risk of decreased bone mineral density that may lead to weakened or brittle bones, or fracture

If any of these affects you severely, contact your doctor.

TARO-CARBAMAZEPINE can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

This is not a complete list of side effects. For any unexpected effects while taking TARO-CARBAMAZEPINE contact your doctor or pharmacist.

HOW TO STORE IT

• 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.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to:

    Canada Vigilance Program Health Canada

    Postal Locator 1908C

    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^TM Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.

This document plus the full product monograph, prepared for health professionals can be found at:

http://www.taro.ca

or by contacting the sponsor, Taro Pharmaceuticals, Inc. at: 1-800-268-1975

Taro Pharmaceuticals Inc.

130 East Drive,

Brampton, Ontario

L6T 1C1

TARO is a registered trademark of Taro

Pharmaceuticals Inc.

Last revised: August 31, 2018