PMS-Carbamazepine (Pharmascience, 200 mg, 100 mg, 400 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR 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:

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

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

When it should not be used:

You should not use pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR if:

• You are allergic (hypersensitive) to carbamazepine or to any

  of the other ingredients of pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR (See What the non-medicinal ingredients are) If you think you may be allergic, ask your doctor for advice. Do not take pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR if you are allergic to other trycyclic 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 monoamine-oxidase inhibitors (MAOIs).
  • You are also taking the drug voriconazole (Vfend) for treatment of an infection.

  • pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-

    CR should not be used to relieve trivial pain in the face or headaches.

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

What the medicinal ingredient is:

Carbamazepine.

What the important nonmedicinal ingredients are:

pms-CARBAMAZEPINE 200 mg Tablets: cellulose compounds, magnesium stearate, silicon dioxide.

pms-CARBAMAZEPINE 100 mg and 200 mg chewable tablets: cherry-mint flavour, corn starch, erythrosine, gelatin, glycerin, magnesium stearate, silicon dioxide, sodium starch glycolate, stearic acid, sugar.

pms-CARBAMAZEPINE-CR 200 and 400 mg: acrylic esters, cellulose compounds, iron oxides, magnesium stearate, silicon dioxide, talc, titanium dioxide, castor oil derivative.

What dosage forms it comes in:

pms-CARBAMAZEPINE is available in the following forms:

• Tablets containing 200 mg carbamazepine.
• Chewable tablets containing 100 mg or 200 mg carbamazepine.
• CR tablets (controlled-release tablets, which can be divided) containing 200 mg or 400 mg carbamazepine.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Blood: Although infrequently reported and very rarely fatal, serious adverse effects affecting blood cell counts have been observed during the use of pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR. 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 pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR in order to detect as early as possible any possible signs of a blood disorder. Your doctor should discontinue pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR, 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 pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR in this case.

• Cancer: Long-term toxicity studies in rats have

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

BEFORE you use pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR talk to your doctor or pharmacist if:

• 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 carbamezepine) for a prolonged period of time.

• Of 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 pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR (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.

  If you are planning on becoming pregnant, discuss the potential benefits against any potential hazards of pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR with your doctor. This is especially important during the first three months of pregnancy. The risk to a fetus may be less if pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR is:

  • the only drug used to control seizures
  • used at the lowest dose that still controls seizures
  • Your doctor may recommend that you take folic acid before and during your pregnancy and vitamin K during the last weeks of pregnancy.
  • The doctor may recommend that the newborn receive vitamin K and be observed for liver and gall bladder problems.
  • If you are a women taking hormonal contraceptive (birth control medicine), pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR may render this contraceptive ineffective. Therefore, you should use a different or additional non-hormonal method of contraception while you are taking pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR. 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, ask your doctor or health professional.
  • If you are breast-feeding. pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR 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.

  • pms-CARBAMAZEPINE and pms-CARBAMAZEPINE-

    CR may affect male fertility or cause abnormal sperm.

  • Of any other medicines (prescription and non-prescription) you are taking.
  • Of 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 these 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).

Periodic eye examinations are recommended while taking pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR.

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

INTERACTIONS WITH THIS 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 pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR, 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 pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR. The hormonal contraceptive may become less effective and you should use another contraceptive method (non-hormonal).

• Avoid alcohol consumption when taking pms-

  CARBAMAZEPINE or pms-CARBAMAZEPINE-CR.

• Do not drink grapefruit juice or eat grapefruit since this can

  increase the effect of pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR. Other juices, like orange juice or apple juice, do not have this effect.

PROPER USE OF THIS MEDICATION

Usual dose:

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

• Never increase or decrease the recommended dose of pms-

  CARBAMAZEPINE or pms-CARBAMAZEPINE-CR you are taking unless your doctor tells you to.

• If you are taking pms-CARBAMAZEPINE or pms-

  CARBAMAZEPINE-CR, 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

• pms-CARBAMAZEPINE Tablets should be taken in 2-4

  divided doses daily, with meals whenever possible.

• pms-CARBAMAZEPINE-CR tablets should be swallowed

  unchewed with a little liquid during or after a meal.

  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 pms-CARBAMAZEPINE or pms-CARBAMAZEPINE-CR 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

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

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

Very rare

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

HOW TO STORE IT

• Store at room temperature (below 30^oC).

• Protect from humidity, such as in bathrooms where you

  shower often.

• Protect pms-CARBAMAZEPINE chewable tablets from light.
• 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 0701E

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ 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 obtained by contacting Pharmascience Inc. at 1-888-550-6060.

Pharmascience Inc.

Montreal Quebec

H4P 2T4

www.pharmascience.com

Last revised: April 8, 2014