Generic Artemether/Lumefantrine

This medication is used to treat malaria in adults and children. The two ingredients in this medication belong to a class of drugs known as antimalarials. Malaria is an infection caused by mosquito bites received while traveling or living in regions of the world where malaria is common. Malaria parasites enter the body, and live in body tissues such as red blood cells or the liver. This medication is used to kill the malaria parasites living inside red blood cells. In some cases, you may need to take a different medication (such as primaquine) to kill the malaria parasites living in the liver. Both treatments may be needed for a complete cure and to avoid the return of infection (relapse). This product is not used to prevent malaria. The United States Centers for Disease Control provide updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before starting treatment with this medication.

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions regarding the information, ask your doctor or pharmacist. Take this medication by mouth, with food, exactly as prescribed by your doctor. This medication is usually taken twice a day with a meal for 3 days (6 doses) or as directed by your doctor. On your first day of treatment, take your first dose with food, followed by your second dose 8 hours later. Then each day for the next 2 days, take one dose in the morning and one dose in the evening. It is important to take every dose of this medication with food or milk, infant formula, pudding, porridge, or broth. Food helps this medication work better. Tell your doctor if you are unable to eat. Dosage (number of tablets per dose) is based on your medical condition, weight, and response to treatment. It is very important to continue taking this medication exactly as prescribed by your doctor. Do not take more or less of this drug than prescribed. Do not skip any doses. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few doses. Skipping doses or stopping the medication too early may make the infection more difficult to treat and result in a return of the infection. This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day. If you or your child cannot swallow tablets, the artemether/lumefantrine tablets may be crushed and mixed with one or two teaspoons (5 to 10 milliliters) of water in a clean container at the time your dose is due. Do not crush tablets or mix with water in advance. Follow the dose of medication with food or drink (such as whole milk, formula, pudding, broth, or porridge). If you or your child vomits within 1 to 2 hours of taking this drug, repeat this dose and contact your doctor immediately. You will need to make sure you have enough tablets to complete your full course of therapy. If you vomit 2 doses, you may need to be treated with a different medication. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of this medication in your bloodstream. Consult your doctor or pharmacist for more details. Seek immediate medical attention if your symptoms of malaria (such as fever, chills, headache, other flu-like symptoms), persist or worsen after 1 to 2 days of taking this medication. If your fever returns after completing this prescription, contact your doctor so that he/she can determine whether the malaria has returned. Quick treatment of malaria is needed to prevent serious, possibly fatal, outcomes.

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 infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using artemether/lumefantrine, tell your doctor or pharmacist 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 medication may make you dizzy, or cause you to feel tired, or weak. Do not drive, use machinery, or perform any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). 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 and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.

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 and resume your usual dosing schedule. Do not double the dose to catch up.

See also Precautions section. The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may interact with this drug include: mefloquine. 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. 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), HIV drugs (such as ritonavir), macrolide antibiotics (such as erythromycin), 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 flecainide, certain beta blockers such as metoprolol, certain tricyclic antidepressants (such as amitriptyline and imipramine), among others. 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), fluoroquinolone antibiotics (such as ciprofloxacin, moxifloxacin), among others. Therefore, before using this product, report all medications you are currently using to your doctor or pharmacist. 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. Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause dizziness. Ask your pharmacist about using those products safely. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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 persist after stopping the medication or if these effects worsen while taking this medication, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she 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. Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting, fast/irregular/pounding heartbeat. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Store at room temperature at 77 degrees F (25 degrees C) away from sunlight and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in bathroom. Keep all medicines 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 for more details about how to safely discard your product.