Uses of Cysteamine Delayed-Release Capsules:

• It is used to treat nephropathic cystinosis.

What do I need to tell my doctor BEFORE I take Cysteamine Delayed-Release Capsules?

• If you are allergic to this medicine (cysteamine delayed-release capsules); any part of this medicine (cysteamine delayed-release capsules); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding. Do not breast-feed while you take this medicine (cysteamine delayed-release capsules).

This medicine may interact with other drugs or health problems.

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 (cysteamine delayed-release capsules) 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 Cysteamine Delayed-Release Capsules?

For all patients taking this medicine (cysteamine delayed-release capsules):

• Tell all of your health care providers that you take this medicine (cysteamine delayed-release capsules). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (cysteamine delayed-release capsules) affects you.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Avoid drinking alcohol while taking this medicine (cysteamine delayed-release capsules).
• This medicine may raise the chance of ulcers or bleeding from the stomach or bowel. Talk with the doctor.
• Low white blood cell counts have happened with this medicine (cysteamine delayed-release capsules). This may lead to a higher chance of getting an infection. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• If you are pregnant or you get pregnant while taking this medicine (cysteamine delayed-release capsules), call your doctor right away.

Children:

• If your child's weight changes, talk with the doctor. The dose of this medicine (cysteamine delayed-release capsules) may need to be changed.

How is this medicine (Cysteamine Delayed-Release Capsules) best taken?

Use this medicine (cysteamine delayed-release capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Swallow whole. Do not chew or crush.
• Take this medicine (cysteamine delayed-release capsules) with fruit juice (not grapefruit juice) or water.
• You may sprinkle contents of capsule on up to 1/2 cup (4 ounces/120 mL) of applesauce or berry jelly. The contents may also be mixed in 1/2 cup (4 ounces/120 mL) of fruit juice (not grapefruit juice) or water. Do not chew. Take within 30 minutes of mixing.
• Keep taking this medicine (cysteamine delayed-release capsules) as you have been told by your doctor or other health care provider, even if you feel well.
• Take at least 30 minutes before or 2 hours after a meal.
• If you cannot take this medicine (cysteamine delayed-release capsules) without eating, you can eat a little bit of food (about 1/2 cup) within 1 hour before taking this medicine (cysteamine delayed-release capsules) through 1 hour after taking it.
• Always take with a little bit of food or always take on an empty stomach.
• Avoid high-fat food close to when you take this medicine (cysteamine delayed-release capsules).
• Those who have feeding tubes may use this medicine (cysteamine delayed-release capsules). Use as you have been told. Flush the feeding tube after this medicine (cysteamine delayed-release capsules) is given.
• Some other drugs may need to be taken at some other time than this medicine (cysteamine delayed-release capsules). If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than this medicine (cysteamine delayed-release capsules).

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If the next dose is less than 4 hours away, 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 fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Ringing in ears.
• Dizziness or passing out.
• Feeling sleepy.
• Eye pain.
• Stomach pain; black, tarry, or bloody stools; throwing up blood; or throw up that looks like coffee grounds.
• Upset stomach or throwing up.
• Not hungry.
• Low mood (depression).
• A very bad skin reaction (toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Raised pressure in the brain has happened with this medicine (cysteamine delayed-release capsules). Most of the time, this will go back to normal after this medicine (cysteamine delayed-release capsules) is stopped. Sometimes, loss of eyesight may happen and may not go away even after this medicine (cysteamine delayed-release capsules) is stopped. Call your doctor right away if you have a headache or eyesight problems like blurred eyesight, seeing double, or loss of eyesight.
• Very bad skin problems like stretch marks, joint problems, and bone problems like broken bones and deformed bones have happened with this drug. Call your doctor right away if you have any skin changes or bone or joint pain.

What are some other side effects of Cysteamine Delayed-Release Capsules?

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:

• Diarrhea.
• Feeling tired or weak.
• Change in body odor.
• Bad breath.
• Eye irritation.
• Flu-like signs.
• Nose or throat irritation.
• Ear pain.

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 Cysteamine Delayed-Release Capsules?

• Store at room temperature protected from light. Store in a dry place. Do not store in a bathroom.
• Store in the original container. Do not take out the antimoisture cube or packet.
• Keep lid tightly closed.
• 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 (cysteamine delayed-release capsules), 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.