When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to miltefosine, if you have Sjögren-Larsson syndrome, or if you are pregnant.

How to Use This Medicine:
Capsule

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Swallow the capsule whole. Do not crush, break, or chew it.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control to prevent pregnancy during treatment and for 5 months after your last dose.
• You must have a negative pregnancy test before you will be allowed to take this medicine. If you miss a period while you are using this medicine, tell your doctor right away.
• Do not breastfeed for 5 months after taking this medicine.
• Tell your doctor if you have kidney disease or liver disease.
• This medicine may cause serious skin reactions.
• Vomiting and diarrhea are common side effects when you use this medicine, and they may make birth control pills less effective. Use another form of birth control if you have diarrhea and vomiting. Other forms include condoms, a diaphragm, contraceptive foam, or jelly.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Change in how much or how often you urinate
• Dark urine or pale stools, nausea, vomiting, loss of appetite, upper stomach pain, yellow skin or eyes
• Fever

If you notice these less serious side effects, talk with your doctor:

• Decreased appetite
• Diarrhea, nausea, vomiting, or stomach pain
• Headache or dizziness

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088