Mazepine: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

MAZEPINE has been prescribed for you by your doctor:

• to reduce your number of seizures;
• to relieve the pain of trigeminal neuralgia.

What it does:

MAZEPINE (carbamazepine) belongs to the family of medicines called anticonvulsants for treating epilepsy. MAZEPINE is also used for treating the pain of trigeminal neuralgia.

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

When it should not be used:

You should not use MAZEPINE if YOU:

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

  the other ingredients of MAZEPINE (See What the non-medicinal ingredients are). If you think you may be allergic, ask your doctor for advice. Do not take MAZEPINE if you are allergic to other trycyclic drugs such as amitriptyline, trimipramine, imipramine.

• 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 drugs belonging to a special group of

  antidepressants called monoamine-oxidase inhibitors (MAOIs);

• are also taking the drug voriconazole (Vfend) for treatment

  of an infection.

  MAZEPINE 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 MAZEPINE.

What the medicinal ingredient is:

Carbamazepine.

What the nonmedicinal ingredients are:

Eudragit, lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium carboxymethyl starch, and starch.

What dosage forms it comes in:

Tablets containing 200 mg of carbamazepine.

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 MAZEPINE. 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 MAZEPINE in order to detect as early as possible any possible signs of a blood disorder. Your doctor should discontinue MAZEPINE 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 MAZEPINE. Other serious skin reactions such as Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Acute Generalized Exanthematous Pustulosis (AGEP) and Maculopapular Rash have been also reported. Although very rare, serious forms of DRESS and AGEP may also lead to death. Since some cases of these skin reactions have been genetically linked, your doctor may recommend a blood test to determine whether you belong to an at-risk population.
• Contact your doctor immediately if you are developing a rash or any serious skin reactions such as red skin, blistering of the lips, eyes or mouth, and skin peeling accompanied by fever. Your doctor will determine if it is indeed drug related, and discontinue MAZEPINE in this case.

WARNINGS AND PRECAUTIONS

• Cancer: Long-term toxicity studies in rats have indicated a possible cancer risk associated with carbamazepine. Before taking MAZEPINE, discuss with your doctor the potential benefits and possible risks of this treatment for you.

BEFORE you use MAZEPINE talk to your doctor or pharmacist:

• About your medical conditions, especially if you have or have had any liver, kidney or heart 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 MAZEPINE (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 MAZEPINE with your doctor. This is especially important during the first three months of pregnancy. Your doctor may recommend that you take folic acid before and during your pregnancy and vitamin K during the last weeks of pregnancy.
• If you are a women taking hormonal contraceptive (birth control medicine), MAZEPINE may render this contraceptive ineffective. Therefore, you should use a different or additional non-hormonal method of contraception while you are taking MAZEPINE. 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. MAZEPINE is known to pass into breast milk. You must discuss with your doctor the benefits of breastfeeding against any possible risks to the infant.
• MAZEPINE may affect male fertility or cause abnormal sperm.
• Of any other medicines (prescription and nonprescription) 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.

    Periodic eye examinations are recommended while taking MAZEPINE.

    Do not drive a car or operate dangerous machinery until you are sure that MAZEPINE does not cause dizziness, drowsiness 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 MAZEPINE, 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 MAZEPINE. The hormonal contraceptive may become less effective and you should consider using other contraceptive methods.

• Avoid alcohol consumption when taking MAZEPINE.
• Do not drink grapefruit juice or eat grapefruit since this can increase the effect of MAZEPINE. 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 MAZEPINE exactly as your doctor instructed.

• Never increase or decrease the recommended dose of

  MAZEPINE you are taking unless your doctor tells you to.

• If you are taking MAZEPINE, do not suddenly stop taking it without first checking with your doctor. Your doctor will tell you if and when if and when you can stop taking this medicine.

• MAZEPINE tablets should be taken in 2 to 4 divided doses

  daily, with meal whenever possible.

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.

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 MAZEPINE 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

MAZEPINE, can have some side effects in some people. These are often mild and occur more often early in treatment and usually wear off after a few days of treatment.

Check with your doctor as soon as possible if any of the following side effects occur, since they may need medical attention:

More common: loss of muscle coordination, allergic skin reactions, swelling of the ankles, feet or lower legs (oedema), increase in seizures (fits), blurred vision, double vision. Less common: trembling, uncontrolled body movements. Rare: changes in behavior, confusion, weakness, itching with redness and swelling of the eye (conjunctivitis), feeling pressure/pain in the eye (signs of increased pressure in the eye), muscle spasms, uncontrolled eye movements, itching, swollen glands, agitation or hostility (especially in the elderly), fainting, difficulty in speaking or slurred speech, depression with restlessness, nervousness or other mood or mental changes, hallucinations (see or hear things that are not there), ringing or other unexplained sounds in the ears, decreased hearing, troubled breathing, chest pain, fast or unusually slow heartbeat, numbness, tingling in hands and feet, frequent urination, sudden decrease in amount of urine, taste disturbances, unusual secretion of breast milk, breast enlargement in men, swelling and redness along a vein which is extremely tender when touched, often experienced as painful (thrombophlebitis), increased sensitivity of the skin to

sun.

Usually the following side effects do not need medical attention. However, if they last for more than a few days or cause real distress, check with your doctor.

More common: vomiting, nausea, dizziness, sleepiness, unsteadiness, weight gain, headache, dry mouth.

Less common: constipation, diarrhea.

Rare: abdominal pain, aching joints or muscles, increased sweating, loss of appetite, loss of hair, excessive body and facial hair, sexual disturbances, male infertility, red and sore tongue, mouth sores, alterations in skin pigmentation, acne.

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.

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

HOW TO STORE IT

• Store at room temperature (below 30°C).

  • Protect from humidity, such as in bathrooms when you shower often.
  • 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: --------------------------------------------------------------------------

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 0701D

    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 found at:

http://webprod3.hc-sc.gc.ca/dpd-bdpp/index-eng.jsp or by contacting the sponsor,

Biomed 2002 Inc.

5950, Côte de Liesse, Suite100

Ville Mont-Royal

Québec H4T 1E2

September 25, 2014