Hydroxyurea Oral capsule

What is this medicine?

HYDROXYUREA (hye drox ee yoor EE a) is a chemotherapy drug. This medicine is used to treat certain types of leukemias and head and neck cancer. It is also used to control the painful crises of sickle cell anemia.

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:

• HIV or AIDS

• kidney disease or on hemodialysis

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• prior or current interferon therapy

• recent or ongoing radiation therapy

• an unusual or allergic reaction to hydroxyurea, other chemotherapy, 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 your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

People who are not taking this medicine should not be exposed to it. Wash your hands before and after handling your bottle or medicine. Caregivers should wear disposable gloves if they must touch the bottle or medicine. Clean up any medicine powder that spills with a damp disposable towel and throw the towel away in a closed container, such as a plastic bag.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

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?

This medicine may also interact with the following medications:

• didanosine

• stavudine

• live virus vaccines

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?

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop. You will receive regular blood tests during your treatment.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

This medicine may increase your risk to bruise or bleed. Call your doctor or health care professional if you notice any unusual bleeding.

Talk to your doctor about your risk of cancer. You may be more at risk for certain types of cancers if you take this medicine.

You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for at least 6 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for at least a year after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine.

This may interfere with the ability to have or father a child. You should talk with your doctor or health care professional if you are concerned about your fertility.

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

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding.

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine

• signs of decreased red blood cells - unusually weak or tired, fainting spells, lightheadedness

• breathing problems

• burning, redness or pain at the site of any radiation therapy

• changes in skin color

• confusion

• mouth sores

• pain, tingling, numbness in the hands or feet

• seizures

• skin ulcers

• trouble passing urine or change in the amount of urine

• vomiting

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

• headache

• loss of appetite

• red color to the face

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.

See product for storage instructions. Each product may have different instructions. Keep tightly closed. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.