THALIDOMIDE-ORAL (cont.)
SIDE EFFECTS: Drowsiness, dizziness, headache, dry mouth, constipation, loss of appetite or unusual weakness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Report promptly: tingling or numbness of the hands and feet. Unlikely but report promptly: persistent sore throat, fever, slow or rapid heartbeat, swelling of the hands/feet. Very unlikely but report promptly: unusual bruising, mental or mood changes, chest pain, trouble breathing, calf pain/swelling. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS: Before taking thalidomide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: nerve disorders (peripheral neuropathy), blood disorders (neutropenia), heart problems (e.g., low blood pressure, slow heartbeat), seizures. Limit alcohol intake, as it may intensify drug side effects. Caution is advised when performing tasks requiring alertness (e.g., driving) as this drug may cause drowsiness. To avoid dizziness and lightheadedness when rising from a seated or lying position, get up slowly. Because thalidomide can cause severe birth defects or fetal death, several precautions are noted below. - Do not donate blood while using thalidomide. - It is unknown if this drug can be absorbed through the skin. Handle the capsules carefully. Caution is advised if you come in contact with the contents of a broken capsule. If this occurs, wash your hands thoroughly with soap and water. - Males - Use a latex condom when having sexual intercourse with a woman during childbearing years, even if you have had a vasectomy. You must not donate sperm while using thalidomide. - Effective birth control must be used for at least 1 month before beginning thalidomide treatment, during thalidomide treatment, and for 1 month after stopping thalidomide. Reliable birth control is necessary even if you have been unable to get pregnant in the past. Two effective forms of birth control must be used at the same time (unless continuous avoidance of sexual intercourse is your method). Consult your doctor. - Immediately report to your doctor if your period is late, or if you have abnormal vaginal (menstrual) bleeding. Thalidomide must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. Even a single dose of thalidomide taken by a pregnant woman during her pregnancy can cause severe birth defects. If pregnancy does occur during treatment, this drug must be discontinued immediately. It is not known if this drug is excreted into breast milk. Because of the potential for serious reactions in nursing infants, breast-feeding is not recommended while using thalidomide.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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