RIBAVIRIN - ribavirin tablet, film coated
State of Florida DOH Central Pharmacy
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.
What is the most important information I should know about ribavirin tablets?
1. Ribavirin tablets may cause birth defects or death of an unborn child. Therefore, if you are pregnant or your partner is pregnant or plans to become pregnant, do not take ribavirin tablets. Female patients and female partners of male patients being treated with ribavirin tablets must not becomepregnant during treatment and for 6 months after treatment has stopped.
During this time you must have pregnancy tests that show you are not pregnant. You must also use 2 effective forms of birth control during therapy and for 6 months after stopping therapy. Male patients should use a condom with spermicide as one of the two forms.
If pregnancy occurs, report the pregnancy to your healthcare provider right away. (See " What should I avoid while taking ribavirin tablets? ")
If you or a female sexual partner becomes pregnant, you should tell your healthcare provider. There is a Ribavirin Pregnancy Registry that collects information about pregnancy outcomes of female patients and female partners of male patients exposed to ribavirin. You or your healthcare provider are encouraged to contact the Registry at 1-800-593-2214.
2. Ribavirin tablets can cause a dangerous drop in your red blood cell count.
Ribavirin tablets can cause anemia, which is a decrease in the number of red blood cells. This can be dangerous, especially if you have heart or breathing problems. This may cause a worsening of heart (cardiovascular) or circulatory problems. Some patients may get chest pain and rarely, a heart attack. Patients with a history of heart disease have the highest chance of this. Tell your healthcare provider, before taking ribavirin tablets if you have or have ever had any heart or breathing problems. Your healthcare provider should check your red blood cell count before you start treatment with ribavirin tablets and often during the first 4 weeks of treatment. Your red blood cell count may be done more often if you have any heart or breathing problems.
3. Do not take ribavirin tablets alone to treat hepatitis C virus infection.
Ribavirin tablet does not treat hepatitis C virus infections by itself. Ribavirin tablets should be used in combination with peginterferon alfa-2a to treat continuing (chronic) hepatitis C virus infections. You should read the Medication Guide for peginterferon alfa-2a because it has additional important information about treatment that is not covered in this Medication Guide. Your healthcare provider or pharmacist should give you a copy of the peginterferon alfa-2a Medication Guide.
Ribavirin tablet is the antiviral medicine containing ribavirin. It is used in combination with a medicine called peginterferon alfa-2a to treat some adults with chronic hepatitis C whose liver still works normally, and who have not been treated before with a medicine called an interferon alpha. It is not known how ribavirin tablets and peginterferon alfa-2a work together to fight hepatitis C virus infections.
It is not known if treatment with ribavirin tablets and peginterferon alfa-2a combination therapy can cure hepatitis C or if it can prevent liver damage (cirrhosis), liver failure or liver cancer that is caused by hepatitis C virus infections. It is not known if treatment with ribavirin tablets and peginterferon alfa-2a combination therapy will prevent an infected person from spreading the hepatitis C virus to another person.
Treatment with ribavirin tablet has not been studied in children under 18 years of age.
Do not use ribavirin tablets if:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins or 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. Be especially sure to tell your healthcare provider if you take any medicines to treat HIV.
For more information see the peginterferon alfa-2a Medication Guide.
It is also important not to use other ribavirin medicines without talking to your healthcare provider. Please see the peginterferon alfa-2a Medication Guide for the proper use of peginterferon alfa-2a injection.
Avoid the following during ribavirin tablets treatment:
The most serious possible side effects of ribavirin tablets are:
These are not all the possible side effects of ribavirin tablets treatment. For more information, ask your doctor or pharmacist and see the peginterferon alfa-2a Medication Guide.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Hepatitis C infection is a disease caused by a virus that infects the liver. Hepatitis C is more serious for some people than others. Most people who get hepatitis C carry the virus in their blood for the rest of their lives. Most of these people will have some liver damage, but many do not feel sick from the disease. In some people, the liver becomes badly damaged and scarred. This is called cirrhosis. Cirrhosis can cause the liver to stop working. Some people may get liver cancer or liver failure from the hepatitis C virus.
Hepatitis C virus is spread from one person to another by contact with an infected person's blood. You should talk to your healthcare provider about ways to prevent you from infecting others.
Store between 20° - 25°C (68° - 77°F).
Please refer to the peginterferon alfa-2a Medication Guide for storage information about peginterferon alfa-2a injection.
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.
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.
Inactive Ingredients: crospovidone, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, talc and titanium dioxide.
This Medication Guide has been approved by the US Food and Drug Administration.