In Canada—

• Antimalarial

Proguanil ( pro-GWAN-il) belongs to a group of medicines called antimalarials. It is used to prevent malaria, a red blood cell infection transmitted by the bite of a mosquito.

Malaria transmission occurs in large areas of Central and South America, Hispaniola, sub-Saharan Africa, the Indian subcontinent, Southeast Asia, the Middle East, and Oceania. Country-specific information on malaria can be obtained from the Centers for Disease Control and Prevention (CDC), or from the CDC's web site at http://www.cdc.gov/travel.

This medicine may be given together with another medicine to prevent malaria infection.

Proguanil is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For proguanil, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to proguanil. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Proguanil has not been shown to cause birth defects or other problems in humans. However, it is best if pregnant women can avoid traveling to areas where there is a chance of getting malaria.

Breast-feeding—Proguanil passes into the breast milk. This medicine has not been reported to cause problems in nursing babies. However, the amount of proguanil that passes into breast milk is not sufficient to protect the infant from malaria.

Children—Although there is no specific information comparing use of proguanil in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults. However, children should avoid traveling to areas where there is a chance of getting malaria, unless they can take more effective antimalarial medicines.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of proguanil in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Kidney problems, severe—Patients with kidney problems may have an increased chance of side effects.

Take proguanil with a glass of water after meals to lessen possible stomach upset, unless otherwise directed by your doctor.

For young children, proguanil may be given by crushing the tablet and mixing it with milk, honey, or jam.

You may start taking proguanil at least 24 hours before you arrive in an area where there is a chance of getting malaria. This will allow your body to absorb enough medicine to fight the malaria parasites. Also, keep taking this medicine every day while you are in an area where malaria occurs and take it every day for 6 weeks after you leave the area.

No medicine will protect you completely from malaria. However, to protect yourself as completely as possible, keep taking this medicine for the full time your doctor ordered.

Dosing—

The dose of proguanil will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of proguanil. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For prevention of malaria:
    • Adults and children older than 12 years of age—100 milligrams (mg) (1 tablet) a day.
    • Children up to 1 year of age—25 mg (1/4 tablet) a day.
    • Children 1 to 4 years of age—50 mg (1/2 tablet) a day.
    • Children 5 to 8 years of age—75 mg (3/4 tablet) a day.
    • Children 9 to 12 years of age—100 mg (1 tablet) a day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Malaria is spread by the bites of certain kinds of infected female mosquitoes. If you are living in, or will be traveling to, an area where there is a chance of getting malaria, the following mosquito-control measures will help to prevent infection:

• Remain in air-conditioned or well-screened rooms to reduce contact with mosquitoes.
• If possible, sleep under mosquito netting, preferably netting coated or soaked with permethrin, to avoid being bitten by malaria-carrying mosquitoes.
• Wear long-sleeved shirts or blouses and long trousers to protect your arms and legs, especially from dusk through dawn when mosquitoes are out.
• Apply mosquito repellent, preferably one containing DEET, to uncovered areas of the skin from dusk through dawn when mosquitoes are out.
• Use a pyrethrum-containing flying insect spray to kill mosquitoes in living and sleeping quarters during evening and nighttime hours.

If fever or “flu-like” symptoms develop during your travels or within a year (especially within the first 2 months) after you leave an area where malaria occurs, check with your doctor immediately .

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Rare
  • Skin rash or itching 
  
  

• Symptoms of overdose
  • Abdominal or stomach pain;  bloody urine ;  lower back pain;  pain or burning while urinating;  vomiting 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Diarrhea;  headache;  loss of appetite;  mouth sores or ulcers;  nausea;  vomiting 
  
  

• Less common or rare
  • Temporary hair loss 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.