Impavido

Read the Medication Guide provided by your pharmacist before you start taking miltefosine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with food, as directed by your doctor, usually 2 or 3 times daily. The dosage is based on your medical condition, weight, and response to treatment.

Swallow the capsule whole. Do not chew, break, crush, or dissolve the capsule.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Take this drug at evenly spaced intervals.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

Nausea, vomiting, diarrhea, stomach/abdominal pain, joint pain, dizziness, or drowsiness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Take this medication with food to help reduce stomach/intestinal side effects. Drink plenty of fluids to avoid dehydration and kidney problems if vomiting or diarrhea occur.

Remember that this medication has been prescribed because your doctor 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: easy bruising/bleeding, bloody/black/tarry stool, signs of kidney problems (such as change in the amount of urine), yellowing eyes/skin, dark urine, testicular pain/swelling.

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 miltefosine, 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: a certain genetic disorder (Sjogren-Larsson syndrome), kidney disease, liver disease.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

This medication can affect fertility in males. Ask your doctor for more details.

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor, for use during treatment and for 5 months after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor right away. See also Warning section.

Vomiting or diarrhea can make birth control pills not work well. If you are using birth control pills and have vomiting or diarrhea, also use reliable forms of non-hormonal backup birth control (such as condoms, diaphragm with spermicide). Talk to your doctor for more information and about other options.

It is unknown if miltefosine passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 5 months after the last dose. Consult your doctor before breastfeeding.

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. Symptoms of overdose may include: severe vomiting/diarrhea.

Do not share this medication with others.

Lab and/or medical tests (such as kidney and liver function tests, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments.

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.

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.