Miltefosine Oral Capsules

What is this medicine?

MILTEFOSINE (mill TEFF oh seen) is an antiprotozoan agent. It is used to treat certain kinds of parasite infections. It will not work for colds, flu, or other viral infections.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Take this medicine with food. Do not cut, crush or chew this medicine. Follow the directions on the prescription label. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think your are better. Do not skip doses or stop your medicine early.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• unusual bleeding or bruising

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

• diarrhea

• headache

• nausea, vomiting

• stomach pain

What may interact with this medicine?

• birth control pills

• certain medicines that treat or prevent blood clot

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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

• kidney disease

• liver disease

• Sjogren-Larsson-Syndrome

• an unusual or allergic reaction to miltefosine, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

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

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

Do not become pregnant while taking this medicine or for 5 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

This medicine has caused reduced sperm counts in some men. This may interfere with the ability to father a child. This medicine may also interfere with the ability of a woman to have a child. You should talk to your doctor or health care professional if you are concerned about your fertility.

Check with your doctor or health care professional if you get an attack of severe diarrhea, nausea and vomiting, or if you sweat a lot. The loss of too much body fluid can make it dangerous for you to take this medicine. Do not treat diarrhea with over the counter products. Contact your doctor if you have diarrhea that lasts more than 2 days or if it is severe and watery.