Artemether; Lumefantrine Tablets

What is this medication?

ARTEMETHER; LUMEFANTRINE (ar TEM e ther; loo me FAN treen) treats malaria. It works by killing the parasite that causes malaria. It will not treat colds, the flu, or infections caused by bacteria or viruses.

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

COMMON BRAND NAME(S): Coartem

What should I tell my care team before I take this medication?

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 medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with food or a milky drink. Take it as directed on the prescription label at the same time every day. Swallow the tablets whole. You may crush the tablet and mix it with 1 to 2 teaspoons of water in a clean container. Swallow the medication and water right away. If you vomit within 1 hour after taking your dose, take your dose again. If you vomit the second dose, tell your care team. Take all the medication unless your care team tells you to stop it early. Keep taking it even if you think you are better.

Do not take this medication with grapefruit juice.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 2 months for selected conditions, precautions do apply.

Overdosage: If you think you have 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 medication?

Do not take this medication with any of the following:

• Arsenic trioxide
• Carbamazepine
• Certain antibiotics, such as erythromycin, levofloxacin
• Certain medications for blood pressure or heart disease
• Certain medications for depression, anxiety, or mental health conditions
• Certain medications for fungal infections, such as fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole
• Certain medications for irregular heartbeat, such as dronedarone
• Droperidol
• Grapefruit juice
• Lumacaftor; ivacaftor
• Other medications for malaria, such as chloroquine and halofantrine
• Phenytoin
• Pimozide
• Rifampin
• St. John's wort
• Thioridazine

This medication may also interact with the following:

• Antiviral medications for HIV or AIDS
• Dofetilide
• Estrogen or progestin hormones
• Other medications that cause heart rhythm changes
• Ziprasidone

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 medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse. Tell your care team if you get flu-like symptoms (chills, fever, muscle pains, or headaches) again after you have finished all of your medication.

Estrogen and progestin hormones may not work as well while you are taking this medication. If you are using these hormones for contraception, talk to your care team about using a second type of contraception. A barrier contraceptive, such as a condom or diaphragm, is recommended.

Tell your care team if you vomited any of your doses or if you are not able to eat.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing

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

• Dizziness
• Headache
• Joint pain
• Loss of appetite
• Muscle pain
• Unusual weakness or fatigue

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 medication?

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.