Thiola EC

This medication is used to prevent kidney stones in people with a certain inherited disorder (cystinuria). Cystinuria occurs when there is too much of a certain natural substance (the amino acid cystine) in the urine, leading to formation of kidney stones. Tiopronin works by making cystine more dissolvable in the urine.

This medication should be used in combination with other methods to prevent kidney stones (such as drinking plenty of water, taking alkali treatment, following a special diet).

Take this medication by mouth with or without food as directed by your doctor, usually three times daily. You may take this medication with or without food, but it is important to choose one way and take this medication the same way with every dose.

Do not crush or chew the delayed-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Swallow the whole tablet without crushing or chewing.

Avoid drinking alcohol 2 hours before and 3 hours after taking this medication. Drinking alcohol may increase the amount of this medication in your body which may cause serious side effects.

Continue to drink plenty of water and to take the alkali medication as directed by your doctor. Closely follow the diet recommended by your doctor.

The dosage is based on your medical condition, lab tests, and response to treatment. For children, the dosage may be based on their weight.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Tell your doctor if your condition gets worse.

Nausea, diarrhea, or decreased sense of taste/smell may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: muscle/joint pain, swollen lymph nodes, loss of appetite, tiredness, signs of kidney problems (such as change in the amount of urine, painful urination, cloudy/bloody/frothy urine), muscle weakness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking tiopronin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Because of possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Do not share this medication with others.

Lab and/or medical tests (such as urine cystine levels, urine tests) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.