Coartem

What is Coartem used for?

• Coartem is used to treat malaria.

Before taking Coartem, tell your doctor:

• If you are allergic to Coartem; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Low potassium or magnesium levels.
• If you have ever had a long QT on ECG or other heartbeat that is not normal.
• If a family member has a long QT on ECG or has ever died all of a sudden.
• If you have heart problems.
• If you have had a recent heart attack.
• If you are taking any of these drugs: Amitriptyline, carbamazepine, clomipramine, flecainide, imipramine, phenytoin, rifampin, or St. John's wort.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.
• If you are taking or have taken halofantrine within a month of Coartem.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Coartem with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Coartem?

• Tell all of your health care providers that you take Coartem. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Coartem affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• You may need to have an ECG checked before starting Coartem and while taking it. Talk with your doctor.
• Avoid grapefruit and grapefruit juice.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Coartem.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Coartem while you are pregnant.
• This medicine has been shown to cause birth defects in animals. Talk with the doctor.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Coartem best taken?

Use Coartem as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Keep taking Coartem as you have been told by your doctor or other health care provider, even if you feel well.
• Take Coartem with food.
• You may crush tablet and mix with 1 or 2 teaspoons (5 or 10 mL) of water.
• Rinse cup with more water and drink.
• If mixed, swallow the mixed drug right away. Do not store for use at a later time.
• If you throw up within 1 hour of taking Coartem, take 1 more dose.
• If you throw up again after taking the second dose, call your doctor.
• If you are not able to eat food when you take Coartem, talk with your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Coartem that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness.
• Feeling very tired or weak.
• A type of abnormal heartbeat (prolonged QT interval) can happen with Coartem. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.

What are some other side effects of Coartem?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Dizziness.
• Fever or chills.
• Upset stomach or throwing up.
• Belly pain.
• Not hungry.
• Feeling tired or weak.
• Muscle or joint pain.
• Not able to sleep.
• Cough.
• Diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Coartem?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Coartem, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Coartem or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Coartem. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.