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November 25, 2009
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RIBAVIRIN-ORAL CAPSULES (cont.)

SIDE EFFECTS: Nausea, vomiting, headache, dizziness, stomach upset, trouble sleeping, and flu-like symptoms (e.g., fever, chills, sore throat, muscle aches) may occur. If any of these effects persist or worsen, notify your doctor. Promptly tell your doctor if any of these side effects occur: hair loss, loss of appetite, weight loss, rash, itching, changes in taste or hearing. Tell your doctor immediately if any of these serious side effects occur: unusual tiredness and weakness (fatigue), dark urine, yellowing eyes, mental/mood changes (including severe depression or suicidal thoughts), trouble breathing. Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, muscle pain, joint pain, sinus problems (e.g., drainage, pain behind the eyes), rapid breathing, stomach pain. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: This medication is not recommended for use if you have the following medical conditions: severe heart disease, kidney disease, blood disorders (e.g., sickle cell anemia, low hemoglobin), other types of hepatitis (e.g., autoimmune hepatitis). Tell your doctor your medical history, especially of: other liver problems, heart problems, breathing problems, pancreas problems (e.g., pancreatitis), diabetes, any allergies. Caution is advised when using this drug in the elderly because they may be more sensitive to its effects. Caution is advised when using this drug in children because they may be more sensitive to its effects, especially the mental/mood changes including severe depression or suicidal thoughts. This medication must not be used during pregnancy. Consult your doctor for more details and to discuss reliable forms of birth control. It is recommended that men and women use two effective forms of birth control (e.g., latex condoms, birth control medication) while taking this medication since ribavirin may cause fetal harm. These birth control measures should be used during treatment with, and for at least 6 months after using this medication. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended.




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