Carbamazepine Extended-Release Capsules

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): Carbatrol

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
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Low blood cell levels (white cells, red cells, or platelets)
• Mental health conditions
• Porphyria
• Suicidal thoughts, plans, or attempt by you or a family member
• An unusual or allergic reaction to carbamazepine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medication. Take this medication with or without food. The capsules can be opened and the beads sprinkled over food such as applesauce or other similar food product. Take your doses at regular intervals. Do not take your medication more often than directed. Do not stop taking except on your care team's advice.

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. While this medication may be prescribed for selected conditions, precautions do apply.

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 for HIV or AIDS that are given in combination with cobicistat
• Delavirdine
• MAOIs, such as 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, such as phenobarbital
• Certain antibiotics, such as clarithromycin, erythromycin, or troleandomycin
• Cimetidine
• Cyclosporine
• Danazol
• Dicumarol
• Doxycycline
• Estrogen or progestin hormones
• Grapefruit juice
• Isoniazid, INH
• Levothyroxine and other thyroid hormones
• Lithium
• Loratadine
• Medications for angina or blood pressure
• Medications for cancer
• Medications for depression, anxiety, or other mental health conditions
• Medications for fungal infections, such as fluconazole, itraconazole, or ketoconazole
• Medications for HIV or AIDS
• Medications for seizures
• Medications that help you fall asleep
• Methadone
• Niacinamide
• Praziquantel
• Propoxyphene
• Rifampin or rifabutin
• 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 regular checks on your progress. Do not change brands or dosage forms of this medication without discussing it 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. You may also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Estrogen and progestin hormones may not work as well while you are taking this medication. A barrier contraceptive, such as a condom or diaphragm, is recommended if you are using these hormones for contraception. Talk to your care team about effective forms of contraception.

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 sunscreen. Do not use sun lamps, tanning beds, or tanning booths.

This medication may cause thoughts of suicide or depression. This includes sudden changes in mood, behaviors, or thoughts. These changes can happen at any time but are more common in the beginning of treatment or after a change in dose. Call your care team right away if you experience these thoughts or worsening depression.

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.