Ribavirin, Oral

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KEY POINTS

• This medicine is taken by mouth along with other medicine to treat hepatitis C. Take it exactly as directed.
• This medicine can cause severe birth defects. It must not be used by women who are pregnant or by the male partners of women who are pregnant.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause anemia, severe psychiatric side effects, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antiviral; nucleoside analogue

Generic and brand names: ribavirin, oral; Copegus; Moderiba; Rebetol; Ribasphere

What is this medicine used for?

Ribavirin is taken by mouth (capsules) along with other medicines to treat hepatitis C. This medicine alone is not effective in the treatment of hepatitis C. Other medicines such as interferon shots must also be given in order for the treatment to be effective.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A weakened immune system from cancer treatment, diseases such as HIV/AIDS, or from taking steroid medicines or medicines to prevent organ transplant rejection
• Breathing problems or lung disease
• Depression, hallucinations, or other mental illnesses
• Diabetes
• Eye problems
• Heart disease or a heart attack
• High blood pressure
• High triglyceride levels
• Kidney problems
• Liver disease (other than hepatitis C virus infection)
• Problems with drug or alcohol abuse
• Sickle cell anemia or other blood disorders
• Thyroid problems.

Tell your provider if you have received interferon treatment for hepatitis C in the past.

You should not take this medicine if you are also taking didanosine.

Females of childbearing age: This medicine can cause birth defects. Read the information that comes in the medicine package. Your healthcare provider will check that you are not pregnant before starting this treatment, and every month while taking this medicine, and for 6 months after stopping it. Use an effective birth control method while you are taking this medicine and for 6 months after stopping it. Talk with your healthcare provider about effective birth control. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

Males: Do not use this medicine if your female partner is pregnant. If your partner becomes pregnant while taking this medicine or within 6 months after you stop taking it, tell your healthcare provider right away.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children. Some brands should not be used in children under a certain age.

This medicine comes in the form of tablets, capsules, or liquid. If you have the tablets or capsules, do not break, crush, or chew them. Swallow them whole.

If you have the liquid form of this medicine, use the measuring spoon, cup, dropper, or oral syringe that comes with the medicine, or ask your pharmacist for one. Do not use a kitchen spoon because the dose may not be correct.

Take this medicine with food, and at the same time each day. Drink plenty of water while taking this medicines.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine must NOT be used by women who are pregnant or by the male partners of women who are pregnant. This medicine can cause severe birth defects. Use 2 forms of birth control to avoid pregnancy while you are using this medicine and for at least 6 months after your treatment ends. If you or your female sexual partner becomes pregnant while taking this medicine or within 6 months after you stop taking it, tell your healthcare provider right away. This is very important whether you are a man or a woman.

This medicine can cause anemia, a decrease in the number of red blood cells. This can be dangerous, especially if you have heart or breathing problems. This may make heart or circulatory problems worse. Some people may have chest pain and rarely, a heart attack.

This medicine can cause severe psychiatric side effects, including depression, thoughts of suicide, aggressive or violent behavior, and hallucinations. Talk with your healthcare provider about this.

You need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Do not drink alcohol while taking these medicines. Alcohol increases the risk of serious side effects.

This medicine is not effective for the treatment of HIV infection. It does not reduce the risk of passing HIV or hepatitis to others through sexual contact or blood contamination. Continue to practice safe sex and do not share needles.

This medicine may make you confused, dizzy, or drowsy. Do not drive or operate machinery unless you are fully alert.

Your mouth may get dry. Drinking plenty of water, chewing sugarless gum, or sucking on hard sugarless candy may help to relieve dry mouth symptoms. This medicine may increase the risk of dental problems. Brush your teeth twice a day and have regular dental check-ups.

This medicine may affect your child’s growth. Talk with your healthcare provider about this.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. This medicine may also affect your blood sugar if you are not diabetic. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; tightness in your chest; swelling of your lips, tongue, and throat; trouble breathing.)

Serious (Report these to your healthcare provider right away.): Depression, hallucinations (seeing or hearing things that are not there), thoughts of suicide, confusion, vision changes, unusual bruising or bleeding, unusual tiredness or weakness, paleness, fast or irregular heartbeat, dark urine, light-colored bowel movements, yellowing of your skin or eyes, chest pain, severe stomach or back pain, severe nausea or vomiting, severe diarrhea, severe skin redness, skin blistering or peeling, trouble breathing, fever, sore throat, cough, severe dizziness or fainting, trouble urinating or painful urination.

Other: Headache; mild tiredness; irritability; muscle or joint pain; mild nausea, vomiting, or diarrhea; dizziness; trouble sleeping; loss of appetite; itching; dry skin; dry mouth; change in sense of taste; hair loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Antiviral medicines such as adefovir (Hepsera) and entecavir (Baraclude)
• Azathioprine (Azasan, Imuran)
• Flu vaccine
• HIV medicines such as abacavir (Ziagen), abacavir/dolutegravir/lamivudine (Triumeq), abacavir/lamivudine (Epzicom), abacavir/lamivudine/zidovudine (Trizivir), didanosine (Videx), efavirenz/emtricitabine/tenofovir (Atripla), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), emtricitabine (Emtriva), emtricitabine/rilpivirine/tenofovir (Complera, Odefsey), emtricitabine/tenofovir (Truvada), lamivudine (Epivir, Epivir-HBV), lamivudine/zidovudine (Combivir), stavudine (Zerit), and zidovudine (Retrovir)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store the medicine at room temperature. You may store the liquid form in the refrigerator. Keep the container tightly closed. Protect from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.