Tasigna (Nilotinib Hydrochloride Monohydrate)

They need to know if you have any of these conditions: -circulation problems in legs -heart disease -history of irregular heartbeat -history of pancreatitis -history of surgery -liver disease -long QT syndrome -low magnesium or potassium levels in the body -total gastrectomy -an unusual or allergic reaction to nilotinib, lactose, gelatin, other medicines, foods, dyes, or preservatives -pregnant or trying to get pregnant -breast-feeding

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food or with grapefruit juice. Take H2-blockers at least 10 hours before or 2 hours after this medicine. Avoid taking antacids within 2 hours of taking this medicine. Do not cut, crush, or chew this medicine. If you cannot swallow the capsules whole, you may open the capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce. Immediately swallow the mixture. Do not store for future use. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor'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 pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 year of age 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.

If you miss a dose, do not make up the missing dose. Take your next dose as scheduled. Do not take double or extra doses.

Do not take this medicine with any of the following medications: -amoxapine -astemizole -bupivacaine -cisapride -clozapine -cyclobenzaprine -disopyramide -droperidol -flecainide -grapefruit or grapefruit juice -halofantrine -haloperidol -maprotiline -methadone -perphenazine -pimozide -quinidine -ranolazine -risperidone -sunitinib -tacrolimus -terfenadine -thioridazine -ziprasidone This medicine may also interact with the following medications: -antacids -antiviral medicines for HIV or AIDS -certain antibiotics like clarithromycin, erythromycin, telithromycin, troleandomycin -dexamethasone -medicines for blood pressure, heart disease, irregular heart beat -medicines for depression, anxiety, or psychotic disturbances -medicines for fungal infections like ketoconazole, itraconazole, voriconazole, fluconazole -medicines for seizures like carbamazepine, phenobarbital, phenytoin -medicines for stomach problems like cimetidine, famotidine, omeprazole, lansoprazole -medicines for sleep -mifepristone -propoxyphene -rifabutin -rifampin -rifapentine -St. John's Wort -tamoxifen -warfarin -zafirlukast

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.

Visit your doctor for checks on your progress. You will need to have regular blood tests while on this medicine. Report any new symptoms promptly. Continue your course of treatment even though you feel ill unless your doctor tells you to stop. Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick. This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding. Do not become pregnant while taking this medicine or for at least 14 days after. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for at least 14 days after the last dose.

Side effects that you should report to your doctor or health care professional as soon as possible: -allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue -breathing problems -chest pain or palpitations -confusion, trouble speaking or understanding -dizziness or fainting -fast, irregular heartbeat -fever or chills, sore throat -increased hunger or thirst -increased urination -light-colored stools -pain, swelling, warmth in the leg -signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark-brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose -sudden numbness or weakness of the face, arm or leg -swelling of the ankles, feet, hands -trouble walking, dizziness, loss of balance or coordination -unusually weak or tired -weight gain -yellowing of the eyes or skin Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): -constipation -diarrhea -headache -loss of appetite -nausea, vomiting -muscle aches -stomach pain -trouble sleeping

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.

Keep out of the reach of children. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine 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.