Uses of Tacrolimus Extended-Release Tablets:

• It is used to keep the body from harming the organ after an organ transplant.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Tacrolimus Extended-Release Tablets?

• If you have an allergy to tacrolimus or any other part of this medicine (tacrolimus extended-release tablets).
• If you are allergic to this medicine (tacrolimus extended-release tablets); any part of this medicine (tacrolimus extended-release tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have a long QT on ECG.
• If you are taking any of these drugs: Cyclosporine or sirolimus.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine (tacrolimus extended-release tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (tacrolimus extended-release tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tacrolimus Extended-Release Tablets?

• Tell all of your health care providers that you take this medicine (tacrolimus extended-release tablets). This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Many other drugs affect how much of this medicine (tacrolimus extended-release tablets) is in your body. This may raise the chance of organ rejection or raise the chance of side effects. If you take other drugs, check with your doctor to see if you need to have your blood work checked more closely while taking them with this medicine (tacrolimus extended-release tablets).
• High blood pressure has happened with this medicine (tacrolimus extended-release tablets). Have your blood pressure checked as you have been told by your doctor.
• High blood sugar has happened with this medicine (tacrolimus extended-release tablets). This includes diabetes that is new or worse.
• Check your blood sugar as you have been told by your doctor.
• Tell your doctor if you have signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Avoid grapefruit and grapefruit juice.
• Avoid drinking alcohol while taking this medicine (tacrolimus extended-release tablets).
• If you are taking a salt substitute that has potassium in it, a potassium-sparing diuretic, or a potassium product, talk with your doctor.
• If you are not up to date with all of your vaccines, talk with your doctor. You may need to have some vaccines before treatment with this drug.
• Talk with your doctor before getting any vaccines. Use of some vaccines with this medicine (tacrolimus extended-release tablets) may either raise the chance of an infection or make the vaccine not work as well.
• The chance of skin cancer may be raised. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Very bad and sometimes deadly holes in the GI (gastrointestinal) tract have happened with this medicine (tacrolimus extended-release tablets). Talk with the doctor.
• A very bad and sometimes deadly brain problem called posterior reversible encephalopathy syndrome (PRES) has happened with this medicine (tacrolimus extended-release tablets). Call your doctor right away if you have signs like feeling confused, lowered alertness, change in eyesight, loss of eyesight, seizures, or very bad headache.
• This medicine may cause a type of abnormal heartbeat (prolonged QT interval). If this happens, the chance of other unsafe and sometimes deadly abnormal heartbeats may be raised.
• This medicine may affect fertility. Fertility problems may lead to not being able to get pregnant or father a child.
• This medicine may cause harm to the unborn baby if taken during pregnancy. Males and females who will be taking this medicine (tacrolimus extended-release tablets) must talk with the doctor about birth control methods.
• If you are a man and your sex partner is pregnant or gets pregnant at any time while you are being treated, talk with your doctor.
• If you are pregnant or you get pregnant while taking this medicine (tacrolimus extended-release tablets), call your doctor right away.

How is this medicine (Tacrolimus Extended-Release Tablets) best taken?

Use this medicine (tacrolimus extended-release tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking this medicine (tacrolimus extended-release tablets) as you have been told by your doctor or other health care provider, even if you feel well.
• Take this medicine (tacrolimus extended-release tablets) at the same time of day.
• Check your drug when you get a new prescription to make sure you have the right drug. Call your doctor right away if you think you were given the wrong drug or if you are not sure what your drug should look like.
• Take in the morning on an empty stomach. Take at least 1 hour before or at least 2 hours after breakfast.
• Swallow whole with a drink of water.
• Do not chew, break, or crush.
• If you have trouble swallowing, talk with your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it has been more than 15 hours since the missed dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of too much acid in the blood (acidosis) like confusion; fast breathing; fast heartbeat; a heartbeat that does not feel normal; very bad stomach pain, upset stomach, or throwing up; feeling very sleepy; shortness of breath; or feeling very tired or weak.
• Warm, red, or painful skin or sores on the body.
• Chest pain or pressure.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Shakiness.
• Trouble moving around.
• Any unexplained bruising or bleeding.
• A burning, numbness, or tingling feeling that is not normal.
• Pale skin.
• Feeling very tired or weak.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.
• A very bad brain problem called progressive multifocal leukoencephalopathy (PML) has happened with this medicine (tacrolimus extended-release tablets). It may cause disability or can be deadly. Tell your doctor right away if you have signs like confusion, memory problems, low mood (depression), change in the way you act, change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight.

What are some other side effects of Tacrolimus Extended-Release Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, tired, or weak.
• Headache.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Heartburn.
• Trouble sleeping.
• Back pain.
• Joint pain.
• Nose or throat irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tacrolimus Extended-Release Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (tacrolimus extended-release tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.