QUALAQUIN®
quinine sulfate CAPSULES USP 324 mg

This leaflet contains a summary of the most important information about Qualaquin capsules and should be read completely before starting your treatment. This leaflet does not replace talking to your doctor or health care provider about your treatment or medical condition. If you have any questions about your treatment or medical condition, ask your doctor. Only your doctor or other health care provider can prescribe Qualaquin and determine if it is right for you.

Malaria is a serious infection, and if not treated, can be life-threatening. Quinine Sulfate has been used for many years as an effective treatment for uncomplicated malaria caused by the parasite Plasmodium falciparum.

What is Qualaquin?

Qualaquin is a prescription medication used in the treatment of uncomplicated malaria caused by the parasite Plasmodium falciparum.

Qualaquin is NOT approved for the prevention of malaria or for the prevention or treatment of nighttime leg cramps.

Who should not take Qualaquin?

Do not take Qualaquin if you:

• Had previous allergic reactions to quinine, quinidine, or mefloquine (Lariam®).
• Had previous serious side effects to quinine, such as decreased platelets, which are components of blood necessary for clotting.
• Have low levels of an enzyme called Glucose-6-phosphate dehydrogenase (G-6-PD).
• Have myasthenia gravis.
• Have optic neuritis, which is an inflammation of the nerve important for vision.
• Have certain heart rhythm problems or certain inherited abnormalities on your electrocardiogram (ECG). Your doctor will tell you whether your ECG has these abnormalities.

What should I tell my doctor or health care provider before taking Qualaquin?

Tell your doctor or health care provider:

• About all your medical conditions, including any heart, kidney, or liver problems.
• About all the prescription and non-prescription medications you are taking, including vitamins and herbal medications.
• If you are pregnant or could be pregnant. Treatment of malaria is important because it can be a serious disease for a pregnant woman and her unborn baby. Your doctor can tell you more about the benefits and risks of taking this medication during pregnancy for uncomplicated malaria. You and your doctor can decide if Qualaquin is right for you.
• If you are breast-feeding. Small amounts of Qualaquin can pass into the breast milk, but no problems with this medicine have been reported in nursing babies. Discuss with your doctor whether you should breastfeed while taking Qualaquin.

How should I take Qualaquin?

• Take Qualaquin exactly as prescribed.
• Qualaquin is a clear capsule that is taken by mouth.
• Unless directed otherwise by your doctor, the usual dose is 648 mg (two 324 mg capsules) of Qualaquin every 8 hours by mouth at the same time every day for 7 days.
• To lower the chance of stomach upset, take this medication WITH FOOD.
• Finish all the Qualaquin that is prescribed even if you feel better. Do not stop taking the medication without talking to your doctor.
• Do not take more than the amount prescribed. Do not take more than 2 capsules at one time or more than 3 doses in one day. If you take more than the prescribed dose, call your doctor right away.

What should I do if I miss a dose?

If you forget to take Qualaquin, do NOT double the next dose. If it has been more than 4 hours since the missed dose, WAIT and take the regular dose at the next scheduled time. Call your doctor if you are not sure what to do.

What are the possible side effects of Qualaquin?

The most common side effects that you may have when taking Qualaquin are not usually serious, and will usually get better when Qualaquin is stopped. Common side effects with Qualaquin include:

• Headache
• Sweating
• Ringing in your ears
• Dizziness
• Change in color vision
• Nausea
• Flushing
• Mild hearing loss
• Blurred vision

Occasionally, more severe symptoms such as vomiting, diarrhea, and abdominal pain may occur. Rarely, rapid or irregular heartbeat, severe hearing loss, or blindness, may occur. If you experience any severe side effects, call your doctor.

Some patients may experience low blood sugar (hypoglycemia) while taking Qualaquin. Symptoms of low blood sugar include lightheadedness, dizziness, sweating, confusion, shakiness, anxiety, and weakness. If you experience symptoms of low blood sugar, drink some fruit juice or eat a snack, and call your doctor.

Elderly patients may be more sensitive to the side effects of Qualaquin than younger patients, and should quickly report any side effects to their doctor.

Qualaquin has other less common side effects that are not listed here. For a complete list of side effects, ask your doctor. If you notice any side effects not mentioned in this leaflet, or if you have any concerns about a side effect you are having, talk to your doctor.

Qualaquin is NOT approved for the treatment of leg cramps because quinine has not been proven to work for this condition, and may cause serious or life-threatening side effects. Some of the more serious side effects of quinine are blindness, deafness, and abnormal heart rhythm. Your doctor can tell you additional information about serious side effects reported with quinine.

Call your doctor or health care provider right away if:

• You feel worse; or if you do not start feeling better within a day or two of taking Qualaquin.
• If your fevers come back after completing treatment with Qualaquin, call your doctor to make sure that the malaria has not returned.
• You experience serious problems such as:
  • Serious allergic reactions: rash, hives, severe itching, severe flushing, trouble breathing.
  • Eyesight problems: blurred vision, double vision, blindness.
  • Heart problems: chest pain, rapid heartbeats, abnormal heart rhythm.
  • Other reactions: dizziness, confusion, lightheadedness, fainting, seizure.
  • Other problems: abnormal bleeding, (such as severe nosebleed, and blood in the urine, or stool), severe bruising, or the appearance of unusual purple-brown or red spots on your skin.

What about other medications I am taking?

• Tell your doctor about all other prescription and non-prescription medications you are taking, including vitamins and herbal supplements.
• Certain medications should be avoided when you are taking Qualaquin.
• Your doctor has a list of medications that should be avoided or which may require special precautions while taking Qualaquin.

How do I store Qualaquin?

Keep Qualaquin out of reach of children. Keep the capsules in a tightly closed container. Do not refrigerate or freeze. Store at 25-30ºC (77-86ºF).

General advice about Qualaquin:

Do not use Qualaquin for a condition for which it was not prescribed. Do NOT give Qualaquin to other people, even if they have the same symptoms, because it may be harmful.

This leaflet highlights the most important information about Qualaquin. For more information, you should talk with your doctor or health care provider.

Active Ingredients: Quinine Sulfate, USP

Inactive Ingredients: Cornstarch, magnesium stearate, talc

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