The U.S. Food and Drug Administration has banned the sale of all non-approved brands of quinine. Do not purchase Qualaquin on the Internet or from vendors outside of the United States.

Qualaquin is used to treat uncomplicated malaria, a disease caused by parasites. Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia.

Qualaquin will not treat severe forms of malaria, and it should not be taken to prevent malaria.

Some people have used Qualaquin to treat leg cramps, but this is not an FDA-approved use. Using this medication improperly or without the advice of a doctor can result in serious side effects or death.

Qualaquin may also be used for purposes not listed in this medication guide.

Qualaquin can cause serious side effects on your heart, kidneys, or blood cells. Stop taking Qualaquin and call your doctor at once if you have headache with chest pain and severe dizziness, fast or pounding heartbeats, unusual bruising or bleeding (nosebleeds, bleeding gums, purple or red spots under your skin), signs of infection (fever, chills, mouth sores), severe lower back pain, or blood in your urine.

You should not take Qualaquin if you have a heart rhythm disorder called Long QT syndrome, a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G-6-PD), myasthenia gravis, optic neuritis (inflammation of the nerves in your eyes), if you have taken this medicine in the past and it caused a blood cell disorder or severe bleeding.

Some people have used Qualaquin to treat leg cramps, but this is not an FDA-approved use. Using this medication improperly or without the advice of a doctor can result in serious side effects or death.

Follow all directions on your prescription label. Do not take Qualaquin in larger or smaller amounts or for longer than recommended.

Take with food if Qualaquin upsets your stomach.

Take this medication for the full prescribed length of time. Your symptoms may get better before your condition is completely cleared.

If you need surgery or medical tests, tell your caregivers ahead of time that you are using Qualaquin. You may need to stop using the medicine for a short time.

Call your doctor if your symptoms do not improve after 2 days of treatment, or if your symptoms return after you have finished the medicine.

Store at room temperature away from moisture and heat.

You should not use this medication if you have ever had an allergic reaction to Qualaquin or similar medicines such as mefloquine or quinidine, or if you have:

• a heart rhythm disorder called Long QT syndrome;

• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G-6-PD);

• myasthenia gravis;

• optic neuritis (inflammation of the optic nerve); or

• if you have taken Qualaquin in the past and it caused a blood cell disorder, severe bleeding, or kidney problems.

To make sure Qualaquin is safe for you, tell your doctor if you have:

• heart disease or a heart rhythm disorder;

• low levels of platelets in your blood;

• low potassium levels in your blood (hypokalemia); or

• liver or kidney disease.

FDA pregnancy category C. It is not known whether Qualaquin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Quinine can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 16 years old.

Take the missed dose as soon as you remember. If you are more than 4 hours late for your dose, skip the missed dose and take the medicine at your next scheduled dose time. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid taking other anti-malaria medications without your doctor's advice. This includes chloroquine, halofantrine, and mefloquine.

Avoid using antacids without your doctor's advice. Use only the type of antacid your doctor recommends. Some antacids can make it harder for your body to absorb Qualaquin.

Qualaquin may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Do not use Qualaquin to treat any condition that has not been checked by your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Qualaquin may cause serious side effects. Call your doctor at once if you have:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with balance;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• problems with vision or hearing;

• pain, swelling, warmth, or redness in one or both legs;

• severe pain in your side or lower back, blood in your urine, little or no urine;

• low blood sugar (more common in pregnant women)--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;

• loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects of Qualaquin may include:

• headache, blurred vision, changes in color vision;

• sweating or flushing (warmth, redness, or tingly feeling);

• mild dizziness, spinning sensation, ringing in your ears; or

• upset stomach, vomiting, stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many drugs can interact with Qualaquin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with this medicine, especially:

• acetazolamide, sodium bicarbonate;

• aminophylline, theophylline;

• arsenic trioxide, vandetanib;

• bosentan;

• imatinib;

• methadone;

• tacrolimus;

• St. John's wort;

• an antibiotic--azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine, telithromycin, tetracycline;

• an antidepressant--amitriptyline, citalopram, clomipramine, desipramine, nefazodone, venlafaxine;

• antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

• cholesterol-lowering medicine--atorvastatin, simvastatin, lovastatin;

• cough medicine that contains dextromethorphan;

• heart medication--amiodarone, digoxin, dofetilide, disopyramide, dronedarone, flecainide, ibutilide, metoprolol, procainamide, propafenone, quinidine, sotalol, verapamil;

• hepatitis C medications--boceprevir, telaprevir;

• HIV/AIDS medication--atazanavir, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, nevirapine, ritonavir, saquinavir;

• medicine to prevent or treat nausea and vomiting--dolasetron, droperidol, ondansetron;

• medicine to treat a psychiatric disorder--chlorpromazine, clozapine, haloperidol, mesoridazine, pimozide, thioridazine, ziprasidone;

• seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone;

• stomach acid reducers--cimetidine, ranitidine; or

• tuberculosis medication--rifabutin, rifampin, rifapentine.

This list is not complete and many other drugs can interact with Qualaquin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.