Patient Medication Information: uses, side effects, how to take - Mylan-Carbamazepine CR
ABOUT THIS MEDICATION
What the medication is used for:
MYLAN-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:
MYLAN-CARBAMAZAPINE CR belongs to the family of medicines called anticonvulsants for treating epilepsy. MYLAN-CARBAMAZAPINE CR is also used for treating the pain of trigeminal neuralgia and for treating mania.
If you have any questions about how MYLAN-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 MYLAN-CARBAMAZAPINE CR if:
- You are allergic (hypersensitive) to carbamazepine or to any of the other ingredients of MYLAN-CARBAMAZAPINE CR (See What the non-medicinal ingredients are). If you think you may be allergic, ask your doctor for advice. Do not take MYLAN-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 medicines belonging to a special group of antidepressants called monoamine-oxidase inhibitors (MAOIs).
- You are also taking the drugs itraconazole or voriconazole (Vfend) for treatment of an infection.
MYLAN-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 MYLAN-CARBAMAZEPINE CR.
What the medicinal ingredient is:
Carbamazepine.
What the important non-medicinal ingredients are:
MYLAN-CARBAMAZAPINE CR 200 mg and 400 mg Tablets: 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, ethanol (volatile).
What dosage forms it comes in:
MYLAN-CARBAMAZAPINE CR is available in 200 mg and 400 mg tablets.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
|
blistering of the lips, eyes or mouth, and skin peeling accompanied by fever
-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 MYLAN-CARBAMAZEPINE CR in this case.
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BEFORE you use MYLAN-CARBAMAZEPINE CR talk to your doctor or pharmacist:
- About your medical conditions, especially if you have or have had any liver, kidney, or 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, lamotrigine, 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 MYLAN-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. 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 planning on becoming pregnant, discuss the potential benefits against any potential hazards of MYLAN-CARBAMAZEPINE CR.
- If you are a women taking hormonal contraceptive (birth control medicine). MYLAN-CARBAMAZEPINE CR may render this contraceptive ineffective. Therefore, you should use a different or additional non-hormonal method of contraception while you are taking MYLAN-CARBAMAZEPINE CR. This should help to prevent an unwanted pregnancy.
- If you get irregular vaginal bleeding or spotting.
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. 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 non-prescription) 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).
MYLAN-CARBAMAZEPINE CR may affect male fertility or cause abnormal sperm.
Periodic eye examinations are recommended while taking MYLAN-CARBAMAZEPINE CR.
Do not drive a car or operate dangerous machinery until you are sure that MYLAN-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 MYLAN-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 MYLAN-CARBAMAZEPINE CR. The hormonal contraceptive may become less effective and you should use another contraceptive method (non-hormonal).
- Avoid alcohol consumption when taking MYLAN-CARBAMAZEPINE CR.
- Do not drink grapefruit juice or eat grapefruit since this can increase the effect of MYLAN-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 MYLAN-CARBAMAZEPINE CR exactly as your doctor instructed.
- Never increase or decrease the recommended dose of MYLAN-CARBAMAZEPINE CR you are taking unless your doctor tells you to.
- If you are taking MYLAN-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
MYLAN-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 MYLAN-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
MYLAN-CARBAMAZEPINE CR can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
|---|---|---|---|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||
| Only if severe | In all cases | |||
| Very common | Decreased White Blood Cells: fever, sore throat, rash, ulcers in the mouth, swollen glands, or more easily getting infections. | ✓ | ||
Suicidal Thoughts or Actions: thoughts, plans and actions taken for the purpose of killing or harming yourself. | ✓ | |||
| Common | Edema: swelling of the ankles, feet or lower legs. | ✓ | ||
| Rare | Systemic Lupus Erythematosus: red blotchy rash mainly on the face which may be accompanied by fatigue, fever, nausea, loss of appetite. | ✓ | ||
Hallucination: see or hear things that are not there. | ✓ | |||
High Blood Pressure Low Blood Pressure: dizziness, fainting, light-headedness. | ✓ | |||
| Very rare | Glaucoma: pressure/pain in the eye. | ✓ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
Thrombophle bitis: swelling and redness along a vein which is extremely tender or painful when touched. | ✓ | ||
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. | ✓ | ||
Serious Skin Reactions: any combination of itchy skin rash, redness, blistering of the lips, eyes or mouth, skin peeling, accompanied by fever, chills, headache cough, body aches or swollen lymph nodes, joint pain, enlargement of the liver and/or the spleen. Any problems related to the lungs, kidneys, pancreas, heart, bone marrow, thymus, and colon. | ✓ | ||
| Hepatitis: yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite. | ✓ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| Meningitis: fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. | ✓ | ||
| Pancreatitis: severe upper abdominal pain, vomiting, loss of appetite. | ✓ | ||
| Severe decreased urine output due to kidney disorders, blood in the urine. Frequent urination. | ✓ | ||
Porphyria: darkening of urine, severe abdominal pain, excessive sweating, vomiting, and anxiety. | ✓ | ||
| Lack of All Blood Cells: tiredness, headache, being short of breath when exercising, dizziness; looking pale, frequent infections leading to fever, chills, sore throat or mouth ulcers; bleeding or bruising more easily than normal, nose bleeds. | ✓ | ||
| Neuroleptic Malignant Syndrome: muscular stiffness, high fever, altered consciousness high blood pressure, excessive salivation. | ✓ | ||
| Irregular heartbeat, chest pain, fast or unusually slow heartbeat, trouble breathing. | ✓ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM |
|---|
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
Thromboembolism (blood clot): swelling, pain and redness in an arm or a leg that can be warm to touch. You may develop sudden chest pain, difficulty breathing and heart palpitations. | ✓ | ||
Circulatory Collapse: the body is unable to circulate blood to the organs. This is very serious and can lead to death | ✓ | ||
| Disturbed consciousness, fainting. | ✓ | ||
| Hyponatremia (low sodium in the blood): lethargy, confusion, muscular twitching or significant worsening of convulsions. | ✓ | ||
| Unknown | |||
Inflammation of the colon: Diarrhea, abdominal pain and fever. | ✓ | ||
This is not a complete list of side effects. For any unexpected effects while taking MYLAN-CARBAMAZEPINE CR contact your doctor or pharmacist.
HOW TO STORE IT
- Store at room temperature (15°C - 30°C). Protect from humidity, such as in bathrooms where you shower often.
- Keep out of reach and sight of children.
REPORTING SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php). NOTE: Contact your health professional if you need information about how to manage your side effects. 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 can be found at: www.mylan.ca
The full Product Monograph, prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-800-575-1379
Etobicoke, Ontario M8Z 2S6
Revised on: February 12, 2015
Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-800-575-1379 www.mylan.ca