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 artemether or lumefantrine.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take this medicine with food, such as milk, pudding, or broth. Even if you do not feel hungry, try to eat because food helps your body absorb the medicine.
• You may crush the tablet if you have trouble swallowing it. Mix the crushed tablet with 1 or 2 teaspoons of water in a clean container. After you swallow the mixture, rinse the container with a bit more water and swallow that also. Follow with milk, pudding, or broth.
• If you vomit within 2 hours of taking this medicine, take another dose. If you vomit the second dose, tell your doctor right away. You may need a different medicine to treat your condition.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• 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.

• Do not use this medicine if you are also taking carbamazepine, phenytoin, rifampin, or St John's wort.
• Some medicines can affect how artemether/lumefantrine works. Tell your doctor if you are taking any of the following:
  
  • Antibiotics
  • Birth control pills or patches
  • Depression medicine, such as amitriptyline, clomipramine, imipramine
  • HIV or AIDS medicine, such as efavirenz, lopinavir, ritonavir
  • Medicine to treat a fungal infection, such as ketoconazole
  • Medicine to treat heart rhythm problems, such as amiodarone, disopyramide, flecainide, procainamide, quinidine, sotalol
  • Medicine to treat mental illness, such as pimozide, ziprasidone
• Tell your doctor if you have used other medicines to treat your malaria infection, such as halofantrine, mefloquine, or quinine.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, severe heart disease, slow heartbeat (bradycardia), a history of heart rhythm problems (such as prolonged QT interval, congenital long QT interval), or low potassium or magnesium levels.
• Birth control pills or patches may not work as well while you are using this medicine. Use a second form of birth control with your pills or patches.
• Call your doctor if your symptoms do not improve or if they get worse.
• 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
• Chills, fever, headache, or muscle pains after you finish treatment
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting
• Fast, pounding, or uneven heartbeat or pulse
• Lightheadedness or fainting
• Unusual bleeding or bruising
• Yellow skin or eyes

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

• Headache, dizziness
• Joint or muscle pain
• Tiredness or weakness

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