MEDICATION GUIDE

Ribavirin (rye" ba vye' rin) Tablets

Read this Medication Guide carefully before you start taking ribavirin tablets and read the Medication Guide each time you get more ribavirin tablets. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Also read the Medication Guide for peginterferon alfa-2a.

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

1. You should not take ribavirin tablets alone to treat chronic hepatitis C infection. Ribavirin tablets should be used with peginterferon alfa-2a to treat chronic hepatitis C infection.
2. Ribavirin tablets may cause you to have a blood problem (hemolytic anemia) that can worsen any heart problems you have, and cause you to have a heart attack or die. Tell your healthcare provider if you have ever had any heart problems. Ribavirin tablets may not be right for you. If you have chest pain while you take ribavirin tablets, get emergency medical attention right away.
3. Ribavirin tablets may cause birth defects or death of your unborn baby. If you are pregnant or your sexual partner is pregnant, do not take ribavirin tablets. You or your sexual partner should not become pregnant while you take ribavirin tablets and for 6 months after treatment is over. You must use two forms of birth control when you take ribavirin tablets and for the 6 months after treatment.

•   Females must have a pregnancy test before starting ribavirin tablets, every month while treated with ribavirin tablets, and every month for the 6 months after treatment with ribavirin tablets.
•   If you or your female sexual partner becomes pregnant while taking ribavirin tablets or within 6 months after you stop taking ribavirin tablets, tell your healthcare provider right away.

What are ribavirin tablets?

Ribavirin tablets are a prescription medicine used with another medicine called peginterferon alfa-2a to treat chronic (lasting a long time) hepatitis C infection in people 5 years and older whose liver still works normally, and who have not been treated before with a medicine called an interferon alpha. It is not known if ribavirin tablet is safe and will work in children under 5 years of age.

Who should not take ribavirin tablets?

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

Do not take ribavirin tablets if you:

• have certain types of hepatitis caused by your immune system attacking your liver (autoimmune hepatitis)
• have certain blood disorders, such as thalassemia major or sickle-cell anemia (hemoglobinopathies)
• take didanosine (Videx or Videx EC)

Talk to your healthcare provider before starting treatment with ribavirin tablets if you have any of these medical conditions.

What should I tell my healthcare provider before taking ribavirin tablets?

Before you take ribavirin tablets, tell your healthcare provider if you have or have had:

• treatment for hepatitis C that did not work for you
• serious allergic reactions to ribavirin tablets or to any of the ingredients in ribavirin tablets. See the end of this Medication Guide for a list of ingredients.
• breathing problems. Ribavirin tablets may cause or worsen your breathing problems you already have.
• vision problems . Ribavirin tablets may cause eye problems or worsen eye problems you already have. You should have an eye exam before you start treatment with ribavirin tablets.
• certain blood disorders such as anemia
• high blood pressure, heart problems or have had a heart attack . Your healthcare provider should test your blood and heart before you start treatment with ribavirin tablets.
• thyroid problems
• diabetes. Ribavirin tablets and peginterferon alfa-2a combination therapy may make your diabetes worse or harder to treat.
• liver problems other than hepatitis C virus infection
• human immunodeficiency virus (HIV) or other immunity problems
• mental health problems, including depression or thoughts of suicide
• kidney problems
• an organ transplant
• drug addiction or abuse
• infection with hepatitis B virus
• any other medical condition
• are breastfeeding. It is not known if ribavirin passes into your breastmilk. You and your healthcare provider should decide if you will take ribavirin tablets or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Some medicines can cause serious side effects if taken while you also take ribavirin tablets. Some medicines may affect how ribavirin tablets works or ribavirin tablets may affect how your other medicines work.

Especially tell your healthcare provider if you take any medicines to treat HIV, including didanosine (Videx or Videx EC), or if you take azathioprine (Imuran or Azasan).

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

How should I take ribavirin tablets?

• Take ribavirin tablets exactly as your healthcare provider tells you. Your healthcare provider will tell you how much ribavirin tablets to take and when to take it. For children 5 years of age and older your healthcare provider will prescribe the dose of ribavirin tablets based on weight.
• Take ribavirin tablets with food.
• If you miss a dose of ribavirin tablets, take the missed dose as soon as possible during the same day. Do not double the next dose. If you have questions about what to do, call your healthcare provider.
• If you take too much ribavirin tablets, call your healthcare provider or local Poison Control Center right away, or go the nearest hospital emergency room right away.
• Your healthcare provider should do blood tests before you start treatment with ribavirin tablets, at weeks 2 and 4 of treatment, and then as needed to see how well you are tolerating treatment and to check for side effects. Your healthcare provider may change your dose of ribavirin tablets based on blood test results or side effects you may have.
• If you have heart problems, your healthcare provider should check your heart by doing an electrocardiogram before you start treatment with ribavirin tablets, and if needed during treatment.

What should I avoid while taking ribavirin tablets?

• Ribavirin tablets can make you feel tired, dizzy, or confused. You should not drive or operate machinery if you have any of these symptoms.
• Do not drink alcohol, including beer, wine, and liquor. This may make your liver disease worse.

What are the possible side effects of ribavirin tablets?

Ribavirin tablets may cause serious side effects including:

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

• Swelling and irritation of your pancreas (pancreatitis). You may have stomach pain, nausea, vomiting or diarrhea.
• Severe allergic reactions. Symptoms may include hives, wheezing, trouble breathing, chest pain, swelling of your mouth, tongue, or lips, or severe rash.
• Serious breathing problems. Difficulty breathing may be a sign of a serious lung infection (pneumonia) that can lead to death.
• Serious eye problems that may lead to vision loss or blindness.
• Liver problems. Some people may get worsening of liver function. Tell your healthcare provider right away if you have any of these symptoms: stomach bloating, confusion, brown urine, and yellow eyes.
• Severe depression
• Suicidal thoughts and attempts
• Effect on growth in children. Children can experience a delay in weight gain and height increase while being treated with peginterferon alfa-2a and ribavirin tablets. Catch-up in growth happens after treatment stops, but some children may not reach the height that they were expected to have before treatment. Talk to your healthcare provider if you are concerned about your child's growth during treatment with peginterferon alfa-2a and ribavirin tablets.

Call your healthcare provider or get medical help right away if you have any of the symptoms listed above. These may be signs of a serious side effect of ribavirin tablets treatment.

Common side effects of ribavirin tablets taken with peginterferon alfa-2a include:

• flu-like symptoms-feeling tired, headache, shaking along with high temperature (fever), and muscle or joint aches
• mood changes, feeling irritable, anxiety, and difficulty sleeping
• loss of appetite, nausea, vomiting, and diarrhea
• hair loss
• itching

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of ribavirin tablets treatment. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please address medical inquiries to MedicalAffairs@zydususa.com or Tel.: 1-877-993-8779.

How should I store ribavirin tablets?

• Store ribavirin tablets between 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
• Keep the bottle tightly closed.

Keep ribavirin tablets and all medicines out of the reach of children.

General information about the safe and effective use of ribavirin tablets

It is not known if treatment with ribavirin tablets in combination with peginterferon alfa-2a will prevent an infected person from spreading the hepatitis C virus to another person while on treatment.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ribavirin tablets for a condition for which it was not prescribed. Do not give ribavirin tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about ribavirin tablets. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ribavirin tablets that is written for healthcare professionals.

What are the ingredients in ribavirin tablets?

Active Ingredient: ribavirin, USP

Inactive Ingredients: crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, talc and titanium dioxide.

Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.

This Medication Guide has been approved by the U.S. Food and Drug Administration.