Artemether, Lumefantrine Oral tablet

What is this medicine?

ARTEMETHER; LUMEFANTRINE is an antimalarial agent. It is used to treat malaria infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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

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

• heart disease
• kidney disease
• liver disease
• an unusual or allergic reaction to artemether; lumefantrine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with food or a milky drink. Do not drink grapefruit juice with this medicine. Follow the directions on the prescription label. The tablets may be crushed and mixed with 1-2 teaspoons of water in a clean container just before the dose. 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 you are better. Do not skip doses or stop your medicine early. If you vomit within 1 hour after taking your dose, take your dose again. If you vomit the second dose, tell your healthcare provider.

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

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

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.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• arsenic trioxide
• cisapride
• droperidol
• grapefruit juice
• other medicines for malaria like chloroquine and halofantrine
• some antibiotics like erythromycin, levofloxacin
• some medicines for blood pressure, heart disease, irregular heartbeats, rhythm
• some medicines for depression, anxiety, or psychotic disturbances

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS
• female hormones, like estrogens or progestins and birth control pills
• medicines for fungal infections like ketoconazole and itraconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Tell your doctor if you get flu-like symptoms (chills, fever, muscle pains, or headaches) again after you have finished all of your medicine.

Birth control pills may not work properly while you are taking this medicine. Talk to your doctor about using an extra method of birth control.

Tell you doctor or healthcare professional if you vomited any of your doses or if you are not able to eat.

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
• irregular heartbeat

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

• cough
• dizziness
• fever or chills
• headache
• loss of appetite
• muscle aches
• nausea, vomiting
• weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.