Carbamazepine Extended-Release Tablets

What is this medication?

CARBAMAZEPINE (kar ba MAZ e peen) prevents and controls seizures in people with epilepsy. It may also be used to treat nerve pain. It works by calming overactive nerves in your body.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tegretol -XR

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Asian ancestry
• Bone marrow disease
• Glaucoma
• Heart disease or irregular heartbeat
• Kidney disease
• Liver disease
• Low blood counts, like low white cell, platelet, or red cell counts
• Porphyria
• Psychotic disorders
• Suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• An unusual or allergic reaction to carbamazepine, tricyclic antidepressants, phenytoin, phenobarbital or other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Swallow whole, do not cut, crush or chew. The tablets should be inspected for chips or cracks. Do not take any tablets that are damaged. Take this medication with food. Take your doses at regular intervals. Do not take your medication more often than directed. Do not stop taking this medication except on the advice of your care team.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Certain medications used to treat HIV infection or AIDS that are given in combination with cobicistat
• Delavirdine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Nefazodone
• Oxcarbazepine

This medication may also interact with the following:

• Acetaminophen
• Acetazolamide
• Barbiturate medications for inducing sleep or treating seizures, like phenobarbital
• Certain antibiotics like clarithromycin, erythromycin or troleandomycin
• Cimetidine
• Cyclosporine
• Danazol
• Dicumarol
• Doxycycline
• Female hormones, including estrogens and birth control pills
• Grapefruit juice
• Isoniazid, INH
• Levothyroxine and other thyroid hormones
• Lithium and other medications to treat mood problems or psychotic disturbances
• Loratadine
• Medications for angina or high blood pressure
• Medications for cancer
• Medications for depression or anxiety
• Medications for sleep
• Medications to treat fungal infections, like fluconazole, itraconazole or ketoconazole
• Medications used to treat HIV infection or AIDS
• Methadone
• Niacinamide
• Praziquantel
• Propoxyphene
• Rifampin or rifabutin
• Seizure or epilepsy medication
• Steroid medications such as prednisone or cortisone
• Theophylline
• Tramadol
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for a regular check on your progress. Do not change brands or dosage forms of this medication without discussing the change with your care team. If you are taking this medication for epilepsy (seizures), do not stop taking it suddenly. This increases the risk of seizures. Wear a Medic Alert bracelet or necklace. Carry an identification card with information about your condition, medications, and care team.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

You may get drowsy, dizzy, or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase drowsiness and dizziness. Avoid alcoholic drinks.

Birth control pills may not work properly while you are taking this medication. Talk to your care team about using an extra method of birth control.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

The coating on the tablets is not absorbed by the body, and you may notice it in your stool. This is no cause for concern.

The use of this medication may increase the chance of suicidal thoughts or actions. Pay special attention to how you are responding while on this medication. Any worsening of mood, or thoughts of suicide or dying should be reported to your care team right away.

Women who become pregnant while using this medication may enroll in the North American Antiepileptic Drug Pregnancy Registry by calling 1-888-233-2334. This registry collects information about the safety of antiepileptic medication use during pregnancy.

This medication may cause a decrease in vitamin D and folic acid. You should make sure that you get enough vitamins while you are taking this medication. Discuss the foods you eat and the vitamins you take with your care team.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Aplastic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, increased bleeding or bruising
• Change in vision
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Infection—fever, chills, cough, or sore throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low sodium level—muscle weakness, fatigue, dizziness, headache, confusion
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling or loosening of the skin, including inside the mouth
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Dizziness
• Drowsiness
• Loss of balance or coordination
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Protect from moisture. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.