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IMPORTANT SAFETY AND PATIENT INFORMATION ABOUT BENZNIDAZOLE TABLETS

What are Benznidazole Tablets?

Benznidazole Tablets are a prescription medicine used to treat children 2 to 12 years of age with Chagas disease (American trypanosomiasis) caused by Trypanosoma cruzi.

This indication is approved under accelerated approval based on the number of treated patients who became Immunoglobulin G (IgG) antibody negative against the recombinant antigens of T cruzi. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Who should not take Benznidazole Tablets?

Do not take Benznidazole Tablets if you have a history of hypersensitivity reactions to benznidazole or other nitroimidazole derivatives or if you have taken disulfiram within the last two weeks. Do not consume alcoholic beverages or products containing propylene glycol for at least 3 days after therapy with Benznidazole Tablets.

Before you take Benznidazole Tablets, tell your healthcare professional about all of your medical conditions, including if you:

• May be pregnant or are planning to become pregnant. Benznidazole Tablets can cause harm to an unborn baby if given to a pregnant woman. Your doctor may perform a pregnancy test before starting treatment. Use effective contraception during treatment with Benznidazole Tablets and for 5 days after the final dose
• Are breastfeeding or plan to breastfeed. Due to the potential for serious adverse reactions and transmission of Chagas disease, breastfeeding is not recommended during treatment with Benznidazole Tablets
• Drink alcohol or consume products containing propylene glycol

Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take Benznidazole Tablets?

• Read the Instructions for Use before taking Benznidazole Tablets and each time you get a refill
• Benznidazole Tablets should be taken exactly as your healthcare professional tells you to take it
• Benznidazole Tablets can be taken whole or broken at scored lines by mouth, with or without food

What should I avoid while taking Benznidazole Tablets?

• Do not drink alcohol or take disulfiram or products containing propylene glycol while taking Benznidazole Tablets
• Alcohol and products containing propylene glycol also should not be taken for at least 3 days after therapy with Benznidazole Tablets

What are the possible side effects of Benznidazole Tablets?

Benznidazole Tablets may cause:

• Abdominal pain
• Skin rash
• Decreased weight and/or decreased appetite
• Headache or dizziness
• Nausea and/or vomiting
• A change in white blood cell count (such as neutropenia or leukopenia)
• Hives and/or itching

The risk information provided here is not comprehensive. To learn more, talk about Benznidazole Tablets with your healthcare professional or pharmacist. Before taking Benznidazole Tablets, please read the full Prescribing Information here.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.