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Important Safety Information

What is THIOLA® EC (tiopronin) delayed-release tablets?

THIOLA EC delayed-release tablets is a prescription medicine. It is used in combination with high fluid intake, alkali (low acid), and dietary changes to help prevent the formation of one type (cystine) of kidney stones in certain adult and pediatric patients that weigh at least 44 lbs (20 kg) and who do not respond to these measures alone.

Who should not take THIOLA EC?

THIOLA EC should not be taken if you:

  • are allergic to THIOLA EC, or any of the ingredients in THIOLA EC.

What should I tell my doctor before taking THIOLA EC?

THIOLA EC may not be right for you. Before taking THIOLA EC, tell your doctor about:

  • all health conditions you may have and any medications you may be taking.
  • if you are pregnant or plan to become pregnant.
  • if you are breastfeeding or plan to breastfeed.

What should I avoid while taking THIOLA EC?

You should avoid drinking alcohol 2 hours before and 3 hours after taking THIOLA EC.

What are possible side effects of THIOLA EC?

Serious Side Effects: THIOLA EC can cause proteinuria (high amounts of protein in urine), including serious kidney problems, and hypersensitivity reactions (including fever, rash, joint pain and enlarged or swollen lymph nodes).

Most Common Side Effects: Nausea, diarrhea or soft stools, sores in the mouth, rash, fatigue, fever, muscle or joint pain, high amounts of protein in urine, vomiting.

These are not all the possible side effects of THIOLA EC. Call your doctor for medical advice about side effects.

You may report negative side effects to Retrophin® Medical Information at 1-877-659-5518, or to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full THIOLA EC Prescribing Information.