Atovaquone, Proguanil Hydrochloride Oral tablet

What is this medicine?

ATOVAQUONE; PROGUANIL (a TOE va kwone; pro GWAN il) is an antimalarial agent. It is used to prevent and to treat malaria infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• kidney disease

• liver disease

• stomach problems

• an unusual or allergic reaction to atovaquone, proguanil, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine at the same time each day with food or a milky drink. The tablets may be crushed and mixed with condensed milk just before the dose. If you vomit within 1 hour after taking your dose, take your dose again. Take all of your medicine as directed even if you think you are better. Do not skip doses or stop your medicine early. To prevent malaria, take this medicine daily starting 1 or 2 days before entering the area, and continue for 7 days after leaving.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• metoclopramide

• rifabutin

• rifampin

• tetracycline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

If you get a fever during or after you are in a malaria-endemic area, call your doctor. Tell your doctor that you may have been exposed to malaria.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

While in areas where malaria is common, take steps to prevent mosquito bites.

1. Stay in air-conditioned or well-screened rooms to reduce human-mosquito contact.

2. Sleep under mosquito netting, preferably one with pyrethrum-containing insecticide.

3. Wear long-sleeved shirts or blouses and long trousers to protect arms and legs.

4. Apply mosquito repellents containing DEET to uncovered areas of skin.

5. Use a pyrethrum-containing flying insect spray to kill mosquitoes.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• changes in vision

• fever or infection

• redness, blistering, peeling or loosening of the skin, including inside the mouth

• unusually weak or tired

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough

• diarrhea

• dizziness

• headache

• loss of appetite

• nausea, vomiting

• stomach pain

• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.