Fexinidazole oral tablets

What is this medication?

FEXINIDAZOLE (fex i NID a zole) is an antiinfective. It is used to treat certain kinds of parasite infections. It will not work for colds, flu, or other viral infections.

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

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

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

• Cockayne syndrome
• Heart failure
• If you often drink alcohol
• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Low levels of calcium, magnesium, or potassium in the blood
• Mental health disease
• An unusual or allergic reaction to fexinidazole, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the tablets whole. Take it with food. Take all of this medicine unless your health care provider tells you to stop it early. Keep taking it even if you think you are better.

Talk to your health care provider about the use of this medicine in children. While it may be prescribed for children as young as 6 years 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?

It is important not to miss any doses. Talk to your health care provider about what to do if you miss a dose.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• Alcohol or any product that contains alcohol
• Cisapride
• Dronedarone
• Mavacamten
• Pimozide
• Thioridazine

This medicine may also interact with the following medications:

• Adefovir
• Bupropion
• Carbamazepine
• Certain antibiotics, such as cefaclor, ciprofloxacin, clarithromycin, erythromycin, levofloxacin, pentamidine, rifampin
• Certain medications for blood pressure, heart disease, irregular heart beat
• Certain medications for depression, anxiety, or other mental health conditions
• Certain medications for fungal infections, such as itraconazole, voriconazole, fluconazole
• Diazepam
• Disulfiram
• Dofetilide
• Duloxetine
• Efavirenz
• Furosemide
• Lansoprazole
• Lovastatin
• Metformin
• Midazolam
• Nisoldipine
• Other medications that cause heart rhythm changes
• Phenytoin
• Saquinavir
• Simvastatin
• St. John's Wort
• Tacrine
• Tizanidine
• Theophylline

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?

Tell your doctor or health care provider if your symptoms do not start to get better or if they get worse.

Some products may contain alcohol. Ask your health care provider if your medicines contain alcohol. Be sure to tell all health care providers you are taking this medicine. Certain medicines, such as fexinidazole and disulfiram, can cause an unpleasant reaction when taken with alcohol. The reaction includes flushing, headache, nausea, vomiting, sweating, and increased thirst. The reaction can last from 30 minutes to several hours.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your health care provider right away.

You may need blood work while you are taking this medicine.

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 (skin rash, itching or hives, swelling of the face, lips, or tongue)
• Anxious
• Changes in emotions or moods
• Depressed mood
• Hallucinations
• Headache
• Heartbeat rhythm changes (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls)
• Infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• Liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• Nausea, vomiting
• Suicidal thoughts, mood changes
• Tremors
• Trouble sleeping

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

• Back pain
• Dizziness
• Lack or loss of appetite
• Stomach pain
• Unusually weak or tired
• Upset stomach

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 at room temperature below 30 degrees C (86 degrees F). Keep this medicine in the original container. Protect from light and moisture. Keep the container tightly closed. Get rid of any unused medicine after the expiration date.

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

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine 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.