RIBAVIRIN - ribavirin tablet, film coated 
Aurobindo Pharma Limited

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MEDICATION GUIDE


Ribavirin Tablets, USP
(rye" ba vye' rin)

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 PEGASYS® (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 PEGASYS® 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.

What are ribavirin tablets?

Ribavirin tablets are a prescription medicine used with another medicine called PEGASYS® (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 tablets are 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:



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:



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 work 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?
 


What should I avoid while taking ribavirin tablets?
 


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?”



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 PEGASYS® include:



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.

You may also report side effects to Aurobindo Pharma USA, Inc. at 1-866-850-2876. 

How should I store ribavirin tablets?
 


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 PEGASYS® 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. They 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

Inactive Ingredients: microcrystalline cellulose, pregelatinised starch (maize), sodium starch glycolate, povidone (Kollidon 30), colloidal silicon dioxide, magnesium stearate, ethyl cellulose, triacetin, hypromellose, iron oxide red, titanium dioxide, and yellow iron oxide.

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

Trademarks are the property of their respective owners.

Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides 



Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

 
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 032, India

Revised: 02/2022

Revised: 4/2022
Aurobindo Pharma Limited