Tacrolimus Oral capsule

What is this medicine?

TACROLIMUS (ta KROE li mus) is used to decrease the immune system's response to a transplanted organ.

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

What should I tell my health care provider before I take this medicine?

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

• diabetes
• heart disease or heart failure
• high blood pressure
• immune system problems
• infection
• kidney disease
• liver disease
• an unusual or allergic reaction to tacrolimus, lactose, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a full glass of water. If you take the medicine with food, always take it with food. Do not take the medicine with grapefruit juice. Follow the directions on the prescription label. Take your medicine at regular intervals. You must take the medicine at the same time each day. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine 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, and call your doctor or health care professional. Call your doctor or health care professional if you vomit after a dose.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• astemizole
• cidofovir
• cisapride
• cyclosporine
• droperidol
• grepafloxacin
• pimozide
• probucol
• ziprasidone

This medicine may also interact with the following medications:

• alcohol and medicines that contain alcohol
• aminoglycosides
• amphotericin B
• antacids
• bromocriptine
• calcium channel blockers like diltiazem, nicardipine, nifedipine, and verapamil
• carbamazepine
• caspofungin
• protease inhibitors
• chloramphenicol
• cimetidine
• cisplatin
• clarithromycin
• danazol
• diuretics
• erythromycin
• ethinyl estradiol
• ganciclovir
• medicines for fungal infections like clotrimazole, fluconazole, itraconazole, ketoconazole, and voriconazole
• metoclopramide
• omeprazole
• phenobarbital
• phenytoin
• rifabutin
• rifampin
• sirolimus
• St. John's wort
• steroid medicines like prednisone or cortisone
• troleandomycin
• vaccines

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 medicine?

Visit your doctor or health care professional for regular checks on your progress. You will need frequent blood checks.

If you get a cold or other infection while receiving this medicine, call your doctor or health care professional. Do not treat yourself. The medicine may decrease your body's ability to fight infections.

This medicine 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.

What side effects may I notice from receiving this medicine?

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
• burning or tingling in the hands or feet
• changes in vision
• chest pain
• difficulty breathing, wheezing
• fever, chills or any other sign of infection
• frequent urination
• increased thirst or hunger
• pain or difficulty passing urine
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• seizures
• swelling of the feet or legs, unusual or sudden weight gain
• unusual bleeding or bruising
• unusually weak or tired
• yellowing of skin or eyes

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

• confusion
• constipation
• diarrhea
• difficulty sleeping
• headache
• nausea
• tremor

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 medicine?

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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.