Tiopronin delayed-release tablets

What is this medication?

TIOPRONIN (tye oh PROE nin) binds with cystine in the body. It is used to prevent kidney stones in patients with cystinuria.

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

COMMON BRAND NAME(S): Thiola EC

What should I tell my care team before I take this medication?

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

• Kidney disease
• An unusual or allergic reaction to tiopronin, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Swallow the tablets whole. You may crush the tablet and mix with 1 tablespoon of applesauce. Swallow the mixture right away. Keep taking it unless your care team tells you to stop.

You can take it with or without food. If it upsets your stomach, take it with food.

Talk to your care team about the use of this medication in children. While this medication 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 almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Alcohol

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 medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. You may need blood work and urine tests while you are taking this medication.

You may need to be on a special diet while you are taking this medication. Talk to your care team about the foods that you eat and the vitamins that you take. Also, find out how many glasses of fluids you need to drink each day.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

What side effects may I notice from receiving this medication?

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
• dark urine
• fever
• joint pain
• mouth sores
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• signs and symptoms of low red blood cells or anemia such as unusually weak or tired; feeling faint or lightheaded; falls; breathing problems
• swelling of the ankles, feet, hands
• swollen or painful glands
• trouble passing urine or change in the amount of urine
• unusual bruising or bleeding

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

• changes in taste
• diarrhea
• nausea, vomiting
• tiredness
• upset stomach
• wrinkling or thinning of the skin

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 medication?

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.