Cysteamine Bitartrate Oral capsule

What is this medicine?

CYSTEAMINE (sis TEE a meen) breaks down cystine in the body. It is used to treat nephropathic cystinosis in children and adults. This medicine is not a cure.

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:

• bone problems

• depression or other nervous system problems

• history of blood disease

• history of stomach bleeding

• liver disease

• seizures

• skin conditions or sensitivity

• stomach or intestine problems

• an unusual or allergic reaction to cysteamine, penicillamine, 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 glass of water. Follow the directions on the prescription label. Capsules of this medicine may be opened and sprinkled on food. Take your medicine at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed 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.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is within 2 hours of your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Interactions are not expected.

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 for regular check ups. You will need regular blood tests while you are taking this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

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

• bone pain or fractures

• breathing problems

• changes in vision

• confusion, depression, other mood changes

• dark urine

• eye pain

• feeling faint or lightheaded, falls

• fever or chills, sore throat

• general ill feeling or flu-like symptoms

• nausea, vomiting

• purple skin lesions

• ringing in the ears

• seizures

• trouble passing urine or change in the amount of urine

• unusually bleeding or bruising

• unusually weak or tired

• yellowing of 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 or diarrhea

• drowsiness

• headache

• loss of appetite

• stomach upset

• unpleasant breath

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 20 and 25 degrees C (68 and 77 degrees F). Store in a dry place away from light. Throw away any unused medicine after the expiration date.

Cysteamine Oral capsule, gastro-resistant

What is this medicine?

CYSTEAMINE (sis TEE a meen) breaks down cystine in the body. It is used to treat nephropathic cystinosis in children and adults. This medicine is not a cure.

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:

• bone problems

• depression or other nervous system problems

• history of blood disease

• history of stomach bleeding

• liver disease

• seizures

• skin conditions or sensitivity

• stomach or intestine problems

• an unusual or allergic reaction to cysteamine, penicillamine, 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 glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Take this medicine on an empty stomach, at least 30 minutes before or 2 hours after food. If it upsets your stomach, you may take it within 1 hour before eating or after eating 4 ounces (1/2 cup) of a low fat food. If you have a hard time swallowing, the capsules may also be opened and sprinkled on 4 ounces (1/2 cup) of applesauce, berry jelly, orange juice, or apple juice. Eat or drink the mixture within 30 minutes of preparation, do not store for later use. You should always take your medicine the same way each time. Take your medicine at regular intervals. Do not take it more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 2 years 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.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is less than 4 hours away, then skip the missed dose and only take your next regularly scheduled dose. Do not take double or extra doses.

What may interact with this medicine?

• alcohol or any product that contains alcohol

• certain medicines for stomach problems like antacids, cimetidine, famotidine, omeprazole, lansoprazole

• sodium bicarbonate

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 for regular check ups. You will need regular blood tests while you are taking this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

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

• bone pain or fractures

• breathing problems

• changes in vision

• confusion, depression, other mood changes

• dark urine

• eye pain

• feeling faint or lightheaded, falls

• fever or chills, sore throat

• general ill feeling or flu-like symptoms

• nausea, vomiting

• purple skin lesions

• ringing in the ears

• seizures

• trouble passing urine or change in the amount of urine

• unusually bleeding or bruising

• unusually weak or tired

• yellowing of eyes or skin

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

• constipation or diarrhea

• drowsiness

• headache

• loss of appetite

• stomach upset

• unpleasant breath

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 20 and 25 degrees C (68 and 77 degrees F). Store in a dry place away from light. 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.