Moderiba 600 Dose Pack

Ribavirin is an antiviral medication.

Ribavirin must be used together with an interferon alfa product (such as Pegasys, PegIntron, Sylatron, or Intron A) to treat chronic hepatitis C.

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

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

Ribavirin is not effective when used alone. It must be used together with an interferon alfa product. You should not take ribavirin with didanosine.

Ribavirin can cause birth defects or death in an unborn baby. Do not use this medicine if you are pregnant, or if you are a man and your sexual partner is pregnant. Use 2 forms of birth control to prevent pregnancy while either sexual partner is taking ribavirin, and for at least 6 months after treatment ends.

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

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;
• severe kidney disease;
• if you are also taking didanosine (Videx); or
• if you are pregnant, or if you are a man whose sexual partner is pregnant.

You should not take ribavirin with peginterferon alfa-2a if you have:

• autoimmune hepatitis; or
• severe liver disease (especially cirrhosis).

To make sure ribavirin is safe for you, tell your doctor if you have:

• heart disease;
• a blood cell disorder such as anemia (low red blood cells);
• breathing problems;
• vision problems;
• liver problems other than hepatitis C;
• a thyroid disorder;
• kidney disease;
• human immunodeficiency virus (HIV or AIDS);
• diabetes;
• a history of depression, mental illness, or suicide attempt;
• a history of organ transplant; or
• if you have ever received treatment for hepatitis C that did not work well.

Ribavirin can cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before taking this medicine and every month during your treatment.

• If you are a woman, do not take ribavirin if you are pregnant.
• If you are a man, do not take ribavirin if your sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.
• Use at least 2 effective forms of birth control to prevent pregnancy while either sexual partner is taking ribavirin. Keep using 2 forms of birth control for at least 6 months after treatment ends.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

If a pregnancy occurs, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of ribavirin on the baby.

It is not known whether ribavirin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

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

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

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;
• 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.

Common side effects may include:

• nausea, flu-like symptoms, tiredness;
• fever, chills or shaking;
• headache;
• mood changes, feeling irritable;
• muscle pain; or
• stomach pain, vomiting, loss of appetite.

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.

Avoid drinking alcohol. It may increase your risk of liver damage.

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.

Tell your doctor about all your current medicines and any you start or stop using, especially:

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

This list is not complete. Other drugs may interact with ribavirin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Ribavirin is not effective when used alone to treat hepatitis C. It must be used together with an interferon alfa product.

Take ribavirin with food.

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

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use ribavirin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Drink extra fluids while you are taking ribavirin to keep from getting dehydrated, especially during exercise or in hot weather.

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.

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

Store ribavirin liquid (oral solution) in the refrigerator. Do not allow it to freeze.

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

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.