Hydrea/Hydroxyurea IS USED FOR:

Reducing the number of painful episodes and blood transfusions needed by adults with sickle cell anemia experiencing recurrent episodes associated with moderate to severe pain. It may also be used for other conditions as determined by your doctor.

Hydroxyurea/Hydrea is an antineoplastic agent. Exactly how it works is unknown, but it is thought to increase the ability of deformed red blood cells to change shape, which may lessen pain associated with sickle cell anemia.

Treatment for:

• Polycythemia vera
• Sickle-cell disease (breaks down cells that are prone to sickle, as well as increasing fetal hemoglobin content)
• Chronic myelogenous leukemia
• Essential thrombocytosis
• AIDS as an adjunct to ddI in combination antiretroviral therapies
• Biochemical research as a DNA replication inhibitor that causes ribonucleotide depletion and results in DNA double strand breaks near replication forks (see DNA repair)

Moderate to severe psoriasis (slows down the rapid division of skin cells)

BEFORE USING Hydrea/Hydroxyurea :

Some medical conditions may interact with Hydroxyurea/Hydrea . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you have allergies to medicines, foods, or other substances
• if you have kidney problems
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you are pregnant, planning to become pregnant, or are breastfeeding

Some MEDICINES MAY INTERACT with Hydroxyurea/Hydrea . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Didanosine/Videx ec because the risk of side effects such as inflammation of the pancreas may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Hydroxyurea/Hydrea may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

HOW TO USE Hydrea/Hydroxyurea :

Use Hydroxyurea/Hydrea as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash your hands before and after handling Hydroxyurea/Hydrea or the bottle it comes in. Wear gloves while you are handling Hydroxyurea/Hydrea or its bottle. Follow your doctor's instructions for disposing of the gloves after you remove them.
• If you have difficulty swallowing, empty the contents of the capsule into a glass of water and drink immediately. Use care when emptying the capsule into water. Do not allow the powder to come into contact with the skin or mucous membranes and do not inhale the powder when opening the capsules. If the powder is spilled, it should be immediately wiped up with a damp towel and disposed of, as should the empty capsules.
• Drinking extra fluids while you are taking Hydroxyurea/Hydrea is recommended. Check with your doctor for instructions.
• Hydroxyurea/Hydrea may be taken with or without food.
• If you miss a dose of Hydroxyurea/Hydrea , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
• Do not use Hydroxyurea/Hydrea if the expiration date has passed. Ask your doctor or pharmacist how to properly dispose of expired medicine.
• Hydroxyurea/Hydrea comes with an additional patient leaflet. Read it carefully and reread it each time you get Hydroxyurea/Hydrea refilled.

Ask your health care provider any questions you may have about how to use Hydroxyurea/Hydrea .

DO NOT USE Hydrea/Hydroxyurea IF:

• you have severe bone marrow depression, low white blood cell counts, low blood platelet levels, or severe anemia
• you are allergic to any ingredient in Hydroxyurea/Hydrea

Contact your doctor or health care provider right away if any of these apply to you.

POSSIBLE SIDE EFFECTS OF Hydrea/Hydroxyurea :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; drowsiness; hair loss; inflammation of the mouth; loss of appetite; nausea; redness of the face.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood disorders, including low numbers of red or white blood cells; blood in the urine; chills; diarrhea; fever; inflammation of the pancreas; liver toxicity; lower back or abdominal pain; painful urination; persistent cough; secondary leukemia; shortness of breath; skin cancer; skin sore or lesions; sore throat; sores on the mouth or lips; unusual bruising or bleeding; vomiting.

IMPORTANT SAFETY INFORMATION:

• PREGNANCY and BREAST-FEEDING: Hydroxyurea/Hydrea has been shown to cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Hydroxyurea/Hydrea during pregnancy. Hydroxyurea/Hydrea is excreted in breast milk. Do not breast-feed while taking Hydroxyurea/Hydrea .
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Hydroxyurea/Hydrea .
• Hydroxyurea/Hydrea may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.
• Hydroxyurea/Hydrea may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
• Use Hydroxyurea/Hydrea with caution in the ELDERLY because they may be more sensitive to its effects.
• LAB TESTS, including complete blood cell and platelet counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Hydroxyurea/Hydrea . Vaccinations may be less effective.
• Hydroxyurea/Hydrea is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.