Malarone Pediatric is a combination medicine used to treat or prevent malaria, a disease caused by parasites. These medicines work by interfering with the growth of parasites in the red blood cells of the human body.

Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Malarone Pediatric may also be used for purposes not listed in this medication guide.

You should not use Malarone Pediatric to prevent malaria if you have severe kidney disease.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine at the same time each day.

Take Malarone Pediatric with food or milk if it upsets your stomach.

If you vomit within 1 hour after taking this medication, take another dose.

If you are take this medicine to prevent malaria:

• Start taking the medicine 1 or 2 days before entering an area where malaria is common. Continue taking the medicine every day during your stay and for at least 7 days after you leave the area.

Use Malarone Pediatric regularly to best prevent malaria. If you stop using the medication early for any reason, talk to your doctor about other forms of malaria prevention.

If you take this medicine to treat malaria:

• Take the medicine every day for 3 days in a row.

• Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

Call your doctor as soon as possible if you have been exposed to malaria, or if you have fever, vomiting, or diarrhea during or after a stay in an area where malaria is common.

No medication is 100% effective in treating or preventing all types of malaria. For best results, keep using the medication as directed.

Store at room temperature away from moisture and heat.

You should not use this medicine if you are allergic to atovaquone or proguanil.

Do not use Malarone Pediatric to prevent malaria if you have severe kidney disease.

Malarone Pediatric should not be used to treat malaria in a child who weighs less than 11 pounds (5 kilograms), and should not be used to prevent malaria in a child who weighs less than 24 pounds (11 kilograms).

Tell your doctor if you have ever had:

• kidney disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Malaria is more likely to cause death in a pregnant woman. If you are pregnant, talk with your doctor about the risks of traveling to areas where malaria is common.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include stomach discomfort, vomiting, mouth sores, hair loss, easy bruising or bleeding, and peeling of the skin on your hands or feet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Malarone Pediatric may cause serious side effects. Call your doctor at once if you have:

• stomach pain (upper right side), loss of appetite;

• tiredness, itching;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Common side effects of Malarone Pediatric may include:

• stomach pain, vomiting, diarrhea;

• mouth sores;

• headache, dizziness, weakness;

• strange dreams;

• itching; or

• cough

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all other medicines you use, especially:

• metoclopramide;

• rifabutin;

• rifampin;

• tetracycline; or

• a blood thinner--warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may affect Malarone Pediatric, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.