PMS-Carbamazepine CR: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

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

If you have any questions about how pms-CARBAMAZAPINE 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-CARBAMAZAPINE CR if:

• You are allergic (hypersensitive) to carbamazepine or to

  any of the other ingredients of pms-CARBAMAZAPINE CR (See What the non-medicinal ingredients are). If you think you may be allergic, ask your doctor for advice. Do not take pms-CARBAMAZAPINE 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 drugs belonging to a special group

  of antidepressants called monoamine-oxidase inhibitors (MAOIs).

• You are also taking the drug voriconazole for treatment

  of an infection.

• pms-CARBAMAZAPINE 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 CR.

What the medicinal ingredient is:

Carbamazepine.

What the non-medicinal ingredients are:

Polyacrylate dispersion 40%, ethylcellulose, microcrystalline cellulose, croscarmellose sodium, purified talc, colloidal anhydrous silica, magnesium stearate, hydroxypropylmethyl cellulose, titanium dioxide, polyethylene glycol, iron oxide yellow, iron oxide red, iron oxide black

What dosage forms it comes in:

Tabelts: 200 mg and 400 mg.

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 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 pms-CARBAMAZEPINE CR in order to detect as early as possible any possible signs of a blood disorder. Your doctor should discontinue 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 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. 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 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 CR, discuss with your doctor the potential benefits and possible risks of this treatment for you.

  BEFORE you use pms-CARBAMAZEPINE CR be sure to tell 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, lamotrigine, sodium valproate and/or carbamazepine) 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 CR (Carbamazepine), there is an approximately 1 in 4 (25%) chance that you could also have an allergic reaction to oxcarbazepine.

  • If you are pregnant.

  • If you are planning on becoming pregnant, discuss the

    potential benefits against any potential hazards of pms-CARBAMAZEPINE CR 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), 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 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. 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.

  • 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 behaviour. 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 pms-CARBAMAZEPINE CR.

Do not drive a car or operate dangerous machinery until you are sure that pms-CARBAMAZEPINE CR 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 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 CR. The hormonal contraceptive may become less effective and you should consider using other contraceptive methods.

• Avoid alcohol consumption when taking pms-

  CARBAMAZEPINE CR.

• Do not drink grapefruit juice or eat grapefruit since this can increase the effect of pms-CARBAMAZEPINE CR. Other juices, like orange juice or apple juice, do not have this effect.

PROPER USE OF T

PROPER USE OF THIS MEDICATION

Usual dose:

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

• Never increase or decrease the recommended dose of

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

• If you are taking 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 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.

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:

Missed Dose:

If you miss a dose, take your 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

pms-CARBAMAZEPINE CR 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 (conjunctivis), 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.

Very rare Signs of

angioedema and severe allergic

reactions (swelling of the face, eyes, or tongue, difficulty swallowing,

wheezing, hives and generalized itching, rash, fever,

abdominal cramps, chest discomfort or tightness, difficulty breathing,

unconsciousness).

√

Signs of serious skin

reactions (skin rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling,

accompanied by fever, chills,

headache cough, body aches)

√

Signs of hepatitis

(Yellowing of the white of your eyes or your skin).

√

Signs of meningitis

(fever, nausea,

vomiting, headache, stiff neck and

extreme sensitivity to bright light).

√

Signs of pancreatitis

(severe upper

abdominal pain, vomiting, loss of appetite).

√

HOW TO STORE IT

• 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.

MORE INFORMATION

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

Last revised: October 15, 2012

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 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.