What Tacrolimus Capsules is used for and how to use it
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Tacrolimus Capsules - Consumer Medicine Information

Manufacture: Dr. Reddy's Laboratories Inc
Country: India
Condition: Graft-versus-host disease, Organ Transplant, Rejection Reversal, Organ Transplant, Rejection Prophylaxis
Class: Calcineurin inhibitors
Form: Capsules
Ingredients: tacrolimus, croscarmellose sodium, lactose monohydrate, magnesium stearate, gelatin, iron oxide red, iron oxide yellow, titanium dioxide

What is the Most Important Information I Should Know About Tacrolimus Capsules

Tacrolimus capsules can cause serious side effects, including:

  1. Increased risk of cancer. People who take tacrolimus capsules have an increased risk of getting some kinds of cancer, including skin and lymph gland cancer (lymphoma).
  2. Increased risk of infection. Tacrolimus capsules is a medicine that affects your immune system. Tacrolimus capsules can lower the ability of your immune system to fight infections. Serious infections can happen in people receiving tacrolimus capsules that can cause death. Call your doctor right away if you have symptoms of an infection such as:
    • fevers
    • weats or chills
    • cough or flu-like symptoms
    • muscle aches
    • warm, red, or painful areas on your skin

What are Tacrolimus Capsules

Tacrolimus capsules are a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, or heart transplant and tacrolimus capsules are not for use with medicines called cyclosporines (Gengraf, Neoral, and Sandimune).

Tacrolimus capsules are not for use with a medicine called sirolimus (Rapamune) in people who have had a liver or heart transplants.

It is not known if tacrolimus capsules are safe and effective when used with sirolimus in people who have had kidney transplants.

It is not known if tacrolimus capsules are safe and effective in children who have had a kidney or heart transplants.

Who Should not Take Tacrolimus Capsules

Do not take tacrolimus capsules if you are allergic to tacrolimus or any of the ingredients in tacrolimus capsules. See the end of this leaflet for a complete list of ingredients in tacrolimus capsules.

What Should I Tell My Doctor Before Taking Tacrolimus Capsules

Before you take tacrolimus capsules, tell your doctor if you:

  • plan to receive any live vaccines
  • have or have had liver, kidney or heart problems
  • are pregnant or plan to become pregnant. Tacrolimus capsules may harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • Are breastfeeding or plan to breastfeed. Tacrolimus capsules can pass into your breast milk. You and your doctor should decide if you will take tacrolimus capsules or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take:

  • cyclosporine (Gengraf, Neoral, and Sandimune)
  • sirolimus (Rapamune)
  • nelfinavir (Viracept)
  • telaprevir (Incivek)
  • boceprevir (Victrelis)
  • amiodarone (Cordarone, Nexterone, Pacerone)

Ask your doctor or pharmacist if you are not sure if you take any of the medicines listed above. Tacrolimus capsules may affect the way other medicines work, and other medicines may affect how tacrolimus capsules works. Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

How Should I Take Tacrolimus Capsules

  • Take tacrolimus capsules exactly as your doctor tells you to take it.
  • Your doctor will tell you how many tacrolimus capsules to take and when to take them.
  • Your doctor may change your tacrolimus capsules dose if needed. Do not stop taking or change your dose of tacrolimus capsules without talking to your doctor.
  • Take tacrolimus capsules with or without food.
  • Take tacrolimus capsules the same way everyday. For example, if you choose to take tacrolimus capsules with food, you should always take tacrolimus capsules with food.
  • Take tacrolimus capsules at the same time each day. For example, if you take your first dose at 7: 00 a.m. you should take your second dose at 7:00 p.m
    • Taking tacrolimus capsules at the same time each day helps to keep enough medicine in your body to give your transplanted organ the around-the-clock medicine it needs.
  • Do not eat grapefruit or drink grapefruit juice while taking tacrolimus capsules.
  • If you take too much tacrolimus capsules, call your doctor or go to the nearest hospital emergency room right away.

What Should I Avoid While Taking Tacrolimus Capsules

  • While you take tacrolimus capsules you should not receive any live vaccines such as:
    • flu vaccine through your nose
    • measles
    • mumps
    • rubella
    • polio by mouth
    • BCG (TB vaccine)
    • yellow fever
    • chicken pox (varicella)
    • typhoid
  • Avoid exposure to sunlight and UV light such as tanning machines. Wear protective clothing and use a sunscreen.

What are the Possible Side Effects of Tacrolimus Capsules

Tacrolimus capsules may cause serious side effects, including:

  • See What is the Most Important Information I Should Know About Tacrolimus Capsules
  • high blood sugar (diabetes). Your doctor may do certain tests to check for diabetes while you take tacrolimus capsules. Call your doctor right away if you have:
    • frequent urination
    • increased thirst or hunger
    • blurred vision
    • confusion
    • drowsiness
    • loss of appetite
    • fruity smell on your breath
    • nausea, vomiting, or stomach pain
  • kidney problems . Your doctor may do certain tests to check your kidney function while you take tacrolimus capsules.
  • nervous system problems . Call your doctor right away if you get any of these symptoms while taking tacrolimus capsules. These could be signs of a serious nervous system problem:
    • confusion
    • coma
    • muscle tremors
    • numbness and tingling
    • headache
    • seizures
    • vision changes
  • high levels of potassium in your blood. Your doctor may do certain tests to check your potassium level while you take tacrolimus capsules.
  • high blood pressure. Your doctor will monitor your blood pressure while you take tacrolimus capsules.
  • heart problems (myocardial hypertrophy). Tell your doctor right away if you get any of these symptoms of heart problems while taking tacrolimus capsules:
    • shortness of breath
    • chest pain
    • feel lightheaded
    • feel faint

The most common side effects of tacrolimus capsules in people receiving kidney transplant are:

  • infection
  • tremors (shaking of the body)
  • high blood pressure
  • kidney problems
  • constipation
  • diarrhea
  • headache
  • stomach pain
  • trouble sleeping
  • nauseal
  • ow levels of phosphate in your blood
  • swelling of the hands, ankles, or legs
  • weakness
  • pain
  • high levels of fat in your blood
  • high levels of potassium in your blood
  • low red blood cell count (anemia)

The most common side effects of tacrolimus capsules in people receiving liver transplants are:

  • shaking of the body tremors
  • headache
  • diarrhea
  • high blood pressure
  • nausea
  • kidney problems
  • stomach pain
  • trouble sleeping
  • numbness or tingling in your hands or feet
  • anemia
  • pain
  • fever
  • weakness
  • high levels of potassium in the blood
  • low levels of magnesium in the blood

The most common side effects of tacrolimus for heart transplant patients are:

  • kidney problems
  • high blood pressure

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of tacrolimus capsules. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Tacrolimus Capsules

Store Tacrolimus capsules at 20°C-25°C (68°F-77°F)

Safely throw away medicine that is out of date or no longer needed.

Keep tacrolimus capsules and all medicines out of reach of children.

General Information About the Safe and Effective Use of Tacrolimus Capsules

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use tacrolimus capsules for a condition for which it was not prescribed. Do not give tacrolimus capsules to other people, even if they have the same symptoms that you have. It may harm them.

How Does Tacrolimus Capsules Protect My New Organ

The body’s immune system protects the body against anything that it does not recognize as part of the body. For example, when the immune system detects a virus or bacteria it tries to get rid of it to prevent infection. When a person has a liver, kidney or heart transplant, the immune system does not recognize the new organ as a part of the body and tries to get rid of it, too. This is called “rejection”. Tacrolimus capsules protects your new organ by slowing down the body’s immune system.

This Patient Information leaflet summarizes the most important information about tacrolimus capsules. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about tacrolimus capsules that is written for health professionals.

For more information, call 1-888-375-3784.

What are the Ingredients in Tacrolimus Capsules

Active ingredient: tacrolimus

Inactive ingredients: croscarmellose sodium, lactose monohydrate and magnesium stearate. The 0.5 mg capsule shell contains gelatin, iron oxide red, iron oxide yellow and titanium dioxide, the 1 mg capsule shell contains gelatin and titanium dioxide and the 5 mg capsule shell contains gelatin, iron oxide red, iron oxide black, and titanium dioxide.

This Patient Information has been approved by the U.S. Food and Drug Administration.

To reorder additional Patient Information Sheets, Contact Dr. Reddy's Customer Service at 1-866-733-3952.

Manufactured by

Dr. Reddy’s Laboratories Limited

Bachupally - 500 090 INDIA

Revised: 0615