Rebetol

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.

Tell your healthcare provider if you are breastfeeding. It is not known if Rebetol passes into your breast milk. You and your healthcare provider should decide if you will take Rebetol or breastfeed.

• Take Rebetol exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Rebetol to take and when to take it.
• Take Rebetol with food.
• Take Rebetol capsules whole. Do not open, break, or crush Rebetol capsules before swallowing. If you cannot swallow Rebetol capsules whole, tell your healthcare provider.
• If you miss a dose of Rebetol, 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 Rebetol, call your healthcare provider or Poison Control Center at 1-800-222-1222, or go to the nearest hospital emergency room right away.

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.

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.

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

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Anxiety
• black, tarry stools
• body aches or pain
• chest pain
• congestion
• cough or hoarseness
• crying
• depersonalization
• diarrhea
• difficult or labored breathing
• discouragement
• dry mouth
• dryness of the throat
• dysphoria
• euphoria
• feeling sad or empty
• feeling unusually cold
• fever or chills
• general feeling of discomfort or illness
• headache
• hyperventilation
• irregular heartbeats
• irritability
• joint pain
• lack of appetite
• loss of interest or pleasure
• lower back or side pain
• mental depression
• muscle aches and pains
• nausea
• nervousness
• painful or difficult urination
• pale skin
• paranoia
• poor concentration
• quick to react or overreact emotionally
• rapidly changing moods
• restlessness
• right upper abdominal or stomach pain
• runny nose
• shaking
• shivering
• shortness of breath
• sleeplessness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• tender, swollen glands in the neck
• tightness in the chest
• trouble with concentrating
• trouble with sleeping
• trouble with swallowing
• troubled breathing with exertion
• unable to sleep
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes
• vomiting
• wheezing

• Bleeding gums
• blood in the urine or stools
• constipation
• depressed mood
• dry skin and hair
• feeling cold
• hair loss
• husky voice
• muscle cramps and stiffness
• pinpoint red spots on the skin
• right upper abdominal or stomach fullness
• slowed heartbeat
• weight gain

• Blistering, flaking, or peeling of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• being forgetful
• belching
• blurred vision
• bone pain
• change in taste or bad, unusual, or unpleasant (after) taste
• cracked, scaly skin
• crusting, irritation, itching, or reddening of the skin
• difficulty with moving
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• hair loss or thinning of the hair
• heartburn
• indigestion
• lack or loss of strength
• menstrual changes
• pain or tenderness around the eyes and cheekbones
• rash
• sensation of spinning
• sneezing
• stomach discomfort, upset, or pain
• stuffy nose
• swelling
• swollen joints
• weight loss

• Back pain
• burning, dry, or itching eyes
• discharge, excessive tearing
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• skin rash, encrusted, scaly, and oozing

• Change in hearing
• loss of hearing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Rebetol (ribavirin) is an antiviral medication.

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

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

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

Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, weakness, or trouble breathing.

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

Rebetol 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 Rebetol, and 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 Rebetol.

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

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.

Applies to ribavirin: oral capsule, oral solution, oral tablet

Other dosage forms:

• inhalation powder for solution

Along with its needed effects, ribavirin (the active ingredient contained in Rebetol) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ribavirin:

• Anxiety
• black, tarry stools
• body aches or pain
• chest pain
• congestion
• cough or hoarseness
• crying
• depersonalization
• diarrhea
• difficult or labored breathing
• discouragement
• dry mouth
• dryness of the throat
• dysphoria
• euphoria
• feeling sad or empty
• feeling unusually cold
• fever or chills
• general feeling of discomfort or illness
• headache
• hyperventilation
• irregular heartbeats
• irritability
• joint pain
• lack of appetite
• loss of interest or pleasure
• lower back or side pain
• mental depression
• muscle aches and pains
• nausea
• nervousness
• painful or difficult urination
• pale skin
• paranoia
• poor concentration
• quick to react or overreact emotionally
• rapidly changing moods
• restlessness
• right upper abdominal or stomach pain
• runny nose
• shaking
• shivering
• shortness of breath
• sleeplessness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sweating
• tender, swollen glands in the neck
• tightness in the chest
• trouble with concentrating
• trouble with sleeping
• trouble with swallowing
• troubled breathing with exertion
• unable to sleep
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes
• vomiting
• wheezing

• Bleeding gums
• blood in the urine or stools
• constipation
• depressed mood
• dry skin and hair
• feeling cold
• hair loss
• husky voice
• muscle cramps and stiffness
• pinpoint red spots on the skin
• right upper abdominal or stomach fullness
• slowed heartbeat
• weight gain

• Blistering, flaking, or peeling of the skin

Some side effects of ribavirin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• being forgetful
• belching
• blurred vision
• bone pain
• change in taste or bad, unusual, or unpleasant (after) taste
• cracked, scaly skin
• crusting, irritation, itching, or reddening of the skin
• difficulty with moving
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• hair loss or thinning of the hair
• heartburn
• indigestion
• lack or loss of strength
• menstrual changes
• pain or tenderness around the eyes and cheekbones
• rash
• sensation of spinning
• sneezing
• stomach discomfort, upset, or pain
• stuffy nose
• swelling
• swollen joints
• weight loss

• Back pain
• burning, dry, or itching eyes
• discharge, excessive tearing
• feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• skin rash, encrusted, scaly, and oozing

• Change in hearing
• loss of hearing