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Moderiba

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    • Moderiba Patient Information Including Side Effects

    Brand Names: Copegus, Moderiba, Moderiba 1000 Dose Pack, Moderiba 1200 Dose Pack, Moderiba 600 Dose Pack, Moderiba 800 Dose Pack, Rebetol, RibaPak, RibaPak 600, Ribasphere, RibaTab

    Generic Name: ribavirin (oral)

    What is ribavirin?

    Ribavirin is an antiviral medication that is used to treat chronic hepatitis C.

    Ribavirin is not effective when used alone. This medicine must be used in combination with interferon alfa or peginterferon alfa.

    Ribavirin is sometimes given to people taking other antiviral medications to treat hepatitis C.

    Ribavirin may also be used for purposes not listed in this medication guide.

    What are the possible side effects of ribavirin?

    Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

    Ribavirin can cause anemia. In rare cases, this can lead to fatal heart problems. Get emergency medical attention if you have chest pain.

    Call your doctor at once if you have:

    • problems with your vision;
    • severe pain in your upper stomach spreading to your back, nausea, vomiting, diarrhea;
    • new or worsening cough, fever, stabbing chest pain, wheezing, feeling short of breath;
    • severe depression, thoughts about suicide, or thoughts about hurting someone else;
    • signs of serious anemia--pale or yellowed skin, dark colored urine, confusion or weakness; or
    • other signs of low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, easy bruising, unusual bleeding, feeling light-headed.

    Ribavirin can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

    Common side effects may include:

    • nausea, vomiting, loss of appetite;
    • fever, chills or shaking;
    • low blood cell counts, anemia;
    • feeling weak or tired;
    • headache, muscle pain; or
    • mood changes, feeling anxious or irritable.

    This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    What is the most important information I should know about ribavirin?

    You should not use ribavirin if you have autoimmune hepatitis, moderate to severe kidney disease, a hemoglobin blood cell disorder, or if you take didanosine.

    Ribavirin can harm an unborn baby if the mother or the father is using this medicine. Do not use if you are pregnant, or if you are a man whose sex partner is pregnant. Both men and women should use effective birth control while taking ribavirin and for at least 6 months after the last dose.

    Ribavirin is not effective when used alone and must be used in combination with an interferon.

    In rare cases, ribavirin can cause fatal heart problems. Get emergency medical attention if you have chest pain.

    Moderiba Patient Information including How Should I Take

    What should I discuss with my healthcare provider before taking ribavirin?

    You should not take ribavirin if you are allergic to it, or if you have:

    • a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia;
    • autoimmune hepatitis;
    • moderate to severe kidney disease;
    • if you are also taking didanosine; or
    • if you are pregnant, or if you are a man whose sex partner is pregnant.

    When you take ribavirin in combination with other medications: There may be other reasons you should not take the combination treatment. Tell your doctor about all your medical conditions.

    Tell your doctor if you have ever had:

    Both men and women taking ribavirin should use effective birth control to prevent pregnancy. Ribavirin can cause birth defects, miscarriage, or death to an unborn baby if the mother or father is using this medicine.

    • If you are a woman, do not take ribavirin if you are pregnant. You will need to have a negative pregnancy test before taking ribavirin. You will also need pregnancy tests during treatment and for 6 months after your last dose.
    • If you are a man, do not take ribavirin if your sex partner is pregnant.
    • Both men and women should keep using effective birth control for at least 6 months after the last dose of ribavirin.
    • Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin. Your name may be listed on a pregnancy registry to track the effects of ribavirin on the baby.

    It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

    Ribavirin is not approved for use by anyone younger than 3 years old. Ribavirin tablets are not approved for use by anyone younger than 5 years old.

    How should I take ribavirin?

    Ribavirin is not effective when used alone and must be used in combination with other medications to treat hepatitis C.

    Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

    Take ribavirin with food.

    Swallow the capsule whole and do not crush, chew, break, or open it. Tell your doctor if you have trouble swallowing the capsule.

    Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

    Drink extra fluids while you are taking ribavirin to keep from getting dehydrated.

    Ribavirin can cause dry mouth, which could lead to tooth decay or gum disease. If you vomit while taking ribavirin, rinse your mouth out with water to prevent damage to your teeth or gums. Be sure to have regular dental exams while you are taking this medication.

    You will need frequent medical tests.

    Store ribavirin tablets or capsules at room temperature away from moisture, heat, and light.

    Store ribavirin liquid (oral solution) at room temperature or in the refrigerator.

    Moderiba Patient Information including If I Miss a Dose

    What happens if I miss a dose?

    Take the missed dose on the same day you remember it. Skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

    Get your prescription refilled before you run out of medicine completely.

    What happens if I overdose?

    Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

    What should I avoid while taking ribavirin?

    Avoid drinking alcohol. It can make your liver problems worse.

    Using this medicine will not prevent you from passing hepatitis to other people. Follow your doctor's instructions about how to prevent passing the disease to another person.

    What other drugs will affect ribavirin?

    Tell your doctor about all your other medicines, especially:

    • azathioprine; or
    • medicines to treat HIV or AIDS.

    This list is not complete. Other drugs may affect ribavirin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

    Where can I get more information?

    Your doctor or pharmacist can provide more information about ribavirin.

    Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
    Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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