Thiola

THIOLA® (NDC 0178-0900-01), is available for oral administration as 100 mg. round, white, sugar coated tablets in bottles of 100 tablets each. Each tablet is imprinted in red with “M” on one side and blank on the other side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Mission Pharmacal Company, San Antonio, TX 78230 1355.

• Mission Pharmacal Co.

• Mission Pharmacal Company

In the U.S.

• Thiola

Available Dosage Forms:

• Tablet

Therapeutic Class: Renal-Urologic Agent

Your doctor should check your progress at regular visits to make sure that this medicine is working properly and does not cause unwanted effects.

• If you have an allergy to tiopronin or any other part of Thiola (tiopronin).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If this medicine has caused anemia, low platelet count, or low white blood cell count before.
• If you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take Thiola.

This is not a list of all drugs or health problems that interact with this medicine.

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 Thiola with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Very bad health problems like low white blood cell counts, aplastic anemia, and other blood problems may happen with Thiola. Sometimes, these health problems could be deadly. Talk with the doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your urine checked as you have been told by your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Take on an empty stomach. Take 1 hour before or 2 hours after meals.
• Follow the diet plan that your doctor told you about.
• Drink at least ten 10-ounce (300 mL) glasses of water each day, unless told otherwise by your doctor. Drink 2 glasses with each meal and at bedtime. You may wake up at night to urinate; if you do, drink 2 more glasses before returning to bed.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

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.

Applies to tiopronin: oral tablet

Along with its needed effects, tiopronin (the active ingredient contained in Thiola) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tiopronin:

• Yellow skin or eyes

• Muscle pain
• sore throat and fever
• unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur while taking tiopronin:

• Pain, swelling, or tenderness of the skin
• skin rash, hives or itching
• ulcers or sores in mouth

• Bloody or cloudy urine
• chills
• difficulty in breathing
• high blood pressure
• hoarseness
• joint pain
• swelling of feet or lower legs
• tenderness of glands
• unusual bleeding

• Chest pain
• cough
• difficulty in chewing, talking, or swallowing
• double vision
• general feeling of discomfort, illness, or weakness
• muscle weakness
• spitting up blood
• swelling of lymph glands

Some side effects of tiopronin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain
• bloating or gas
• diarrhea or soft stools
• loss of appetite
• nausea and vomiting
• warts
• wrinkling or peeling or unusually dry skin

• Changes in taste or smell

There are no data on the excretion of tiopronin into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, mothers taking tiopronin should not nurse their infants.