Coartem

Headache, dizziness, loss of appetite, weakness, fever, chills, tiredness, muscle/joint pain, nausea, vomiting, abdominal pain, cough, and trouble sleeping may occur. If any of these effects last after stopping the medication or if these effects get worse while taking this medication, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if you have any very serious side effects, including: chest pain, severe dizziness, fainting, fast/irregular/pounding heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking artemether/lumefantrine, tell your doctor or pharmacist if you are allergic to artemether or lumefantrine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent use (within the past month) of any medication to prevent or treat malaria (such as halofantrine, quinine, or quinidine), kidney problems, liver problems.

Artemether/lumefantrine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using artemether/lumefantrine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using artemether/lumefantrine safely.

This drug may make you feel dizzy or tired or weak. Alcohol or marijuana (cannabis) can make you more dizzy or tired. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Be sure to tell your doctor about all medications you take for malaria within the 4 weeks before, during, and after treatment with artemether/lumefantrine. Some antimalarial drugs (such as halofantrine) should not be used within one month of treatment with artemether/lumefantrine. In some cases a serious (possibly fatal) drug interaction may occur.

Many drugs besides artemether/lumefantrine may affect the heart rhythm (QT prolongation), including other antimalarial drugs (such as quinine, quinidine), antiarrhythmic drugs (such as amiodarone, sotalol, procainamide, disopyramide), antipsychotics (such as pimozide, ziprasidone), macrolide antibiotics (such as erythromycin), quinolone antibiotics (such as ciprofloxacin, moxifloxacin), among others.

Other medications can affect the removal of artemether/lumefantrine from your body, which may affect how this product works. Examples include azole antifungals (such as ketoconazole, itraconazole), mefloquine, HIV NNRTIs (such as efavirenz), HIV protease inhibitors (such as nelfinavir), rifamycins (such as rifabutin, rifampin), ritonavir, St. John's wort, some anti-seizure drugs (such as carbamazepine, phenobarbital, phenytoin), among others.

This medication can speed up or slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include clomipramine, flecainide, certain beta blockers such as metoprolol, certain tricyclic antidepressants (such as amitriptyline and imipramine), among others.

This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting, slow/irregular heartbeat.

Do not share this medication with others.

Lab and/or medical tests (such as EKG) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.