Carbatrol Sustained-Release CapsulesGeneric Name: Carbamazepine
Carbatrol Sustained-Release Capsules may rarely cause severe blood problems (eg, aplastic anemia, agranulocytosis). Contact your doctor right away if you develop fever, chills, or sore throat; rash; ulcers or sores in the mouth; unusual bruising or bleeding; unusual tiredness; or swollen lymph nodes. Lab tests, including complete blood cell counts, will be performed before and during treatment with Carbatrol Sustained-Release Capsules. These tests will be used to check for side effects.
Carbatrol Sustained-Release Capsules may rarely cause serious and sometimes fatal skin reactions. Contact your doctor at once if you develop red, swollen, blistered, or peeling skin with or without fever. The risk of this reaction may be greater in Asian patients. Asian patients may need to have a blood test before they start Carbatrol Sustained-Release Capsules to determine whether they have a greater risk of developing a severe skin reaction.
Carbatrol Sustained-Release Capsules are used for:
Controlling certain types of epileptic seizures. It is also used to treat severe pain of the jaw or cheek caused by a facial nerve problem (trigeminal neuralgia). It may also be used for other conditions as determined by your doctor.
Carbatrol Sustained-Release Capsules are an anticonvulsant. It works to control seizures by blocking certain nerve impulses in the brain. It works to treat trigeminal neuralgia by altering nerve impulses in certain facial nerves, which relieves pain.
Do NOT use Carbatrol Sustained-Release Capsules if:
- you are allergic to any ingredient in Carbatrol Sustained-Release Capsules
- you are allergic to tricyclic antidepressants (eg, amitriptyline), cyclobenzaprine, or similar medicines
- you have a history of bone marrow depression or other serious blood disorders
- you have a severe heart problem called heart block (atrioventricular block)
- you are taking nefazodone
- you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or you have taken an MAOI within the last 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Carbatrol Sustained-Release Capsules:
Some medical conditions may interact with Carbatrol Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are allergic to other seizure medicines (eg, phenytoin, phenobarbital)
- if you have a history of other types of seizures (eg, absence, atonic), increased pressure in the eye (eg, glaucoma), liver or kidney problems, mood or mental problems, suicidal thoughts or actions, or multiple sclerosis
- if you have a history of heart problems (eg, heart failure, heart block, irregular heartbeat), abnormal electrocardiogram (ECG), high blood pressure; or high blood cholesterol
- if you have a history of blood problems, including porphyria or blood problems caused by other medicine
- if you have previously taken Carbatrol Sustained-Release Capsules
Some MEDICINES MAY INTERACT with Carbatrol Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:
- MAOIs (eg, phenelzine) because of a severe reaction, including severe high blood pressure and high fever, may occur
- Nefazodone because its effectiveness may be decreased by Carbatrol Sustained-Release Capsules
- Many prescriptions and nonprescription medicines (eg, used for infections, mental or mood problems, allergies, pain, high blood pressure, cancer, asthma, inflammation, aches and pains, headaches, HIV, blood thinning, thyroid problems, seizures, birth control), multivitamin products, and herbal or dietary supplements (eg, St. John's wort) may interact with Carbatrol Sustained-Release Capsules, increasing the risk of side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if Carbatrol Sustained-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Carbatrol Sustained-Release Capsules:
Use Carbatrol Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take Carbatrol Sustained-Release Capsules by mouth with or without food.
- Swallow Carbatrol Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
- If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a teaspoonful of applesauce or similar food. Mix the medicine with the applesauce or similar food and swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing.
- Eating grapefruit or drinking grapefruit juice may increase the risk of Carbatrol Sustained-Release Capsules's side effects. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
- Do not suddenly stop taking Carbatrol Sustained-Release Capsules. You may have an increase risk of side effects (eg, seizures). If you need to stop Carbatrol Sustained-Release Capsules or add a new medicine, your doctor will gradually lower your dose.
- Take Carbatrol Sustained-Release Capsules on a regular schedule to get the most benefit from it.
- Taking Carbatrol Sustained-Release Capsules at the same time each day will help you remember to take it.
- Continue to take Carbatrol Sustained-Release Capsules even if you feel well. Do not miss any doses.
- If you miss a dose of Carbatrol Sustained-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Carbatrol Sustained-Release Capsules.
Important safety information:
- Carbatrol Sustained-Release Capsules may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Carbatrol Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Check with your doctor before you drink alcohol while you are using Carbatrol Sustained-Release Capsules.
- Do not take more than the recommended dose without checking with your doctor.
- Carbatrol Sustained-Release Capsules may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Carbatrol Sustained-Release Capsules may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Carbatrol Sustained-Release Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Carbatrol Sustained-Release Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Tell your doctor or dentist that you take Carbatrol Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
- Carbatrol Sustained-Release Capsules may interfere with certain lab tests, including thyroid function tests. Be sure your doctor and lab personnel know you are using Carbatrol Sustained-Release Capsules.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Carbatrol Sustained-Release Capsules. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Carbatrol Sustained-Release Capsules may cause the results of some pregnancy tests to be wrong. Check with your doctor if you have questions or concerns about your pregnancy test results.
- Lab tests, including complete blood cell counts, liver and kidney function, eye exams, and carbamazepine blood levels, may be performed while you use Carbatrol Sustained-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Carbatrol Sustained-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially agitation or confusion.
- PREGNANCY and BREAST-FEEDING: Carbatrol Sustained-Release Capsules has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Carbatrol Sustained-Release Capsules while pregnant. Carbatrol Sustained-Release Capsules are found in breast milk. Do not breast-feed while taking Carbatrol Sustained-Release Capsules.
Possible side effects of Carbatrol Sustained-Release Capsules:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; drowsiness; dry mouth; nausea; unsteadiness; vomiting.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; calf pain, swelling, or tenderness; change in the amount of urine produced; chest pain; confusion; dark urine; decreased coordination; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; joint pain; loss of appetite; mental or mood changes; pain, tenderness, or unusual swelling in the neck, groin, or under the arms; red, swollen, blistered, or peeling skin; severe or persistent dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; speech problems; stomach pain; sudden unusual weight gain; suicidal thoughts or actions; swelling of the hands, ankles, or feet; swollen lymph nodes; ulcers or sores in the mouth; uncontrolled muscle movements; unusual bruising or bleeding; unusual tiredness; vision or eye problems; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org), or emergency room immediately. Symptoms may include decreased urination; fast or irregular heartbeat; loss of consciousness; muscle twitching or tremor; seizures; severe dizziness or drowsiness; severe nausea or vomiting; slow, shallow, or irregular breathing.Proper storage of Carbatrol Sustained-Release Capsules:
Store Carbatrol Sustained-Release Capsules at 77 degrees F (25 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Carbatrol Sustained-Release Capsules out of the reach of children and away from pets.
- If you have any questions about Carbatrol Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
- Carbatrol Sustained-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
This information is a summary only. It does not contain all information about Carbatrol Sustained-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.