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COARTEM (artemether lumefantrine tablets) ®
(co-AR-tem)
(artemether and lumefantrine) Tablets

Read this patient information before you start taking Coartem (artemether lumefantrine tablets) . There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is Coartem (artemether lumefantrine tablets) ?

Coartem (artemether lumefantrine tablets) is a prescription medicine used to treat uncomplicated malaria in adults and children who weigh at least 11 pounds (5 kg).

Who should not take Coartem (artemether lumefantrine tablets) ?

Do not take Coartem (artemether lumefantrine tablets) if you are allergic to any of the ingredients. See the end of this leaflet for a complete list of ingredients in Coartem (artemether lumefantrine tablets) .

What should I tell my healthcare provider before taking Coartem (artemether lumefantrine tablets) ?

Before you take Coartem (artemether lumefantrine tablets) , tell your healthcare provider about all your medical conditions including if you have:

• heart disease or a family history of heart problems or heart disease
• liver or kidney problems
• recently taken other medicines used to treat malaria
• if you are pregnant or are planning to become pregnant. Coartem (artemether lumefantrine tablets) may increase your risk for loss of pregnancy. Fetal defects have been reported when artemisinins are administered to animals. Talk to your healthcare provider before taking Coartem (artemether lumefantrine tablets) .
• if you are breast-feeding. It is not known if Coartem (artemether lumefantrine tablets) passes into your breast milk. You and your doctor will decide the best way to feed your baby if you take Coartem (artemether lumefantrine tablets) .

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Coartem (artemether lumefantrine tablets) and other medicines may affect each other causing side effects. Coartem (artemether lumefantrine tablets) may affect the way other medicines work and other medicines may affect how Coartem (artemether lumefantrine tablets) works.

Especially tell your doctor if you take:

• any other medicines to treat or prevent malaria
• medicines for your heart
• antipsychotic medicines
• antidepressants
• antibiotics
• antihistamines
• Cisapride (Propulsid®)
• medicines to treat HIV-infection
• hormonal methods of birth control (for example, birth control pills or patch)

Ask your healthcare provider if you are not sure if your medicine is one that is listed above. Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.

How should I take Coartem (artemether lumefantrine tablets) ?

• Take Coartem (artemether lumefantrine tablets) exactly as prescribed.
• If you weigh 77 pounds (35 kg) or more, one dose of Coartem (artemether lumefantrine tablets) is 4 tablets.
• If you weigh less than 77 pounds (35 kg), your healthcare provider will tell you how many tablets to take for each dose.
• A full course of treatment is 6 doses of Coartem (artemether lumefantrine tablets) taken over 3 days:
  • Day 1: take 1 dose; 8 hours later take 1 dose
    Day 2: take 1 dose in the morning, 1 dose in the evening
    Day 3: take 1 dose in the morning, 1 dose in the evening
    Take Coartem (artemether lumefantrine tablets) for 3 days even if you are feeling better.
• Every dose of Coartem (artemether lumefantrine tablets) should be taken with food, such as milk, infant formula pudding, porridge, or broth. It is important for you to eat as soon as you can so that your malaria will go away and not get worse.
• Do not drink grapefruit juice while you take Coartem (artemether lumefantrine tablets) . Drinking grapefruit juice during treatment with Coartem (artemether lumefantrine tablets) can cause you to have too much medicine in your blood.
• Coartem (artemether lumefantrine tablets) may be crushed and mixed with one to two teaspoons of water in a clean container.
• If you vomit within 1 hour of taking Coartem (artemether lumefantrine tablets) you should take another dose of Coartem (artemether lumefantrine tablets) . If you vomit the second dose, tell your healthcare provider. A different medicine may need to be prescribed for you.

Tell your healthcare provider right away if:

• your malaria does not get better
• you vomited any of your doses of Coartem (artemether lumefantrine tablets)
• you are not able to eat
• you get flu-like symptoms (chills, fever, muscle pains, or headaches) again after you have finished your treatment with Coartem (artemether lumefantrine tablets) .
• you have any change in the way your heart beats or a loss of consciousness (fainting).

What are the possible side effects of Coartem (artemether lumefantrine tablets) ?

Coartem (artemether lumefantrine tablets) can cause serious side effects including:

• A heart problem called QT prolongation that can cause an abnormal heartbeat can happen in people who take Coartem (artemether lumefantrine tablets) . The chance of this happening is higher in people with a family history of prolonged QT interval, low potassium (hypokalemia), and in people who take medicines to control heartbeats.
• Allergic reactions. Symptoms of an allergic reaction include: rash, hives, fast heartbeat, trouble swallowing or breathing, swelling of lips, tongue, face, tightness of the throat, or trouble speaking. If you have a serious allergic reaction, stop taking Coartem (artemether lumefantrine tablets) and get emergency medical help right away.

The most common side effects in adults are:

• headache
• feeling dizzy
• feeling weak
• loss of appetite
• muscle and joint pain or stiffness
• feeling tired
• chills
• fever

The most common side effects in children are:

• fever
• cough
• vomiting
• headache
• loss of appetite

These are not all the possible side effects of Coartem (artemether lumefantrine tablets) . For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Coartem (artemether lumefantrine tablets) ?

Store Coartem (artemether lumefantrine tablets) between 59°F to 86°F (15°C to 30°C).

Keep Coartem (artemether lumefantrine tablets) and all medicines out of the reach of children.

General information about the safe and effective use of Coartem (artemether lumefantrine tablets) .

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflets. Do not use Coartem (artemether lumefantrine tablets) for a condition for which it was not prescribed. Do not give Coartem (artemether lumefantrine tablets) to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Coartem (artemether lumefantrine tablets) . If you would like more information about Coartem (artemether lumefantrine tablets) talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Coartem (artemether lumefantrine tablets) that is written for health professionals. For more information call 1-888-2946287.

What are the ingredients in Coartem (artemether lumefantrine tablets) ?

Active ingredients include: artemether, lumefantrine

Inactive ingredients include: colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate 80

Last reviewed on RxList: 5/4/2009
This monograph has been modified to include the generic and brand name in many instances.