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What do I need to do when I get home from the hospital? Although you may be feeling better, there are a few things you should do to lower the chances of being infected again or spreading C. difficile to others. Take DIFICID exactly as prescribed by your doctor and pharmacist. Do not skip doses or stop before you finish taking all the tablets Wash your hands often, especially after going to the bathroom and before preparing food – People who live with you should wash their hands often, as well If your diarrhea comes back or gets worse after you get home, tell your doctor right away Follow your doctor’s instructions If you have any questions, please consult with your doctor or other healthcare professional. Important Safety Information IFICID is contraindicated in patients with D hypersensitivity to fidaxomicin DIFICID should not be used for systemic infections Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. In the event of a severe reaction, discontinue DIFICID Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria The most common adverse reactions reported in clinical trials are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%) This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088). Please see Important Safety Information above and accompanying full prescribing information. © 2013 Optimer Pharmaceuticals, Inc. Jersey City, NJ 07302 April 2013 20226 Frequently asked questions about DIFICID® (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) A guide for patients and caregivers Why has my doctor prescribed DIFICID? Your doctor has prescribed DIFICID to treat your CDAD. Continue taking DIFICID until your full course of therapy is complete. This brochure will provide answers to some common questions about CDAD and DIFICID. Be sure to talk with your healthcare provider if you have any questions about your illness or treatment. DIFICID is a prescription antibacterial drug used in adults 18 years or older to treat diarrhea caused by a certain bacteria called Clostridium difficile. DIFICID should be used only to treat bacterial infections that are caused by or strongly suspected to be caused by Clostridium difficile. Not taking DIFICID exactly as directed by your doctor may decrease its effectiveness or increase the chance that bacteria become resistant to DIFICID or other antibacterial drugs. Please see Important Safety Information on back cover and accompanying full prescribing information. What to know about Clostridium difficile–associated diarrhea (CDAD) What is Clostridium difficile-associated diarrhea (CDAD)? CDAD is diarrhea caused by a germ called Clostridium difficile, also known as C. difficile. Most cases of CDAD occur in patients taking, or who have recently taken, antibiotics for another illness. The most common symptoms of a C. difficile infection include: Watery diarrhea What to know about DIFICID What is DIFICID? DIFICID is a drug for the treatment of CDAD. It is prescribed to adults aged 18 and older. DIFICID treats only CDAD and should not be used to treat any other infection. You may be at risk of CDAD and its recurrence* if you: Are taking or have recently taken antibiotics for another illness Are aged 65 or older Were recently admitted to a hospital or other healthcare facility Fever Loss of appetite Nausea Belly pain and tenderness Have a weakened immune system Have had a prior CDAD episode *Recurrence means your symptoms come back after you finish your treatment. How do I take DIFICID? What can I do to help prevent the spread of CDAD? Make sure that all doctors, nurses, and other healthcare providers wash their hands with soap and water before and after caring for you Only take antibiotics exactly as directed by your doctor Be sure to wash your own hands often, especially after using the bathroom and before eating Visitors should wash their hands before they enter your room and as they leave your room Ask the nurse if visitors need to wear protective gowns and gloves when they visit you The dosage of DIFICID is one 200 mg tablet by mouth twice daily for 10 days. DIFICID may be taken with or without food. What important information should I know about DIFICID? DIFICID is contraindicated and should not be used in patients who are allergic to fidaxomicin. DIFICID treats only CDAD and should not be used to treat any other infection. Although it is common to feel better early in the course of therapy, DIFICID should be taken exactly as directed. Skipping doses or not taking all the medication as directed may: Decrease the effectiveness of DIFICID Increase the chances that the bacteria will become resistant and not be treatable by DIFICID or other drugs in the future If you do not see your healthcare providers wash their hands, please ask them to do so. Please see Important Safety Information on back cover and accompanying full prescribing information. What are the possible side effects associated with taking DIFICID? The most common adverse reactions are nausea, vomiting, abdominal pain, bleeding in the gastrointestinal tract, decrease in the number of red blood cells, and a low number of neutrophils (type of white blood cell). If you develop these or other signs and symptoms, please let your doctor or nurse know right away. What to know about Clostridium difficile–associated diarrhea (CDAD) What is Clostridium difficile-associated diarrhea (CDAD)? CDAD is diarrhea caused by a germ called Clostridium difficile, also known as C. difficile. Most cases of CDAD occur in patients taking, or who have recently taken, antibiotics for another illness. The most common symptoms of a C. difficile infection include: Watery diarrhea What to know about DIFICID What is DIFICID? DIFICID is a drug for the treatment of CDAD. It is prescribed to adults aged 18 and older. DIFICID treats only CDAD and should not be used to treat any other infection. You may be at risk of CDAD and its recurrence* if you: Are taking or have recently taken antibiotics for another illness Are aged 65 or older Were recently admitted to a hospital or other healthcare facility Fever Loss of appetite Nausea Belly pain and tenderness Have a weakened immune system Have had a prior CDAD episode *Recurrence means your symptoms come back after you finish your treatment. How do I take DIFICID? What can I do to help prevent the spread of CDAD? Make sure that all doctors, nurses, and other healthcare providers wash their hands with soap and water before and after caring for you Only take antibiotics exactly as directed by your doctor Be sure to wash your own hands often, especially after using the bathroom and before eating Visitors should wash their hands before they enter your room and as they leave your room Ask the nurse if visitors need to wear protective gowns and gloves when they visit you The dosage of DIFICID is one 200 mg tablet by mouth twice daily for 10 days. DIFICID may be taken with or without food. What important information should I know about DIFICID? DIFICID is contraindicated and should not be used in patients who are allergic to fidaxomicin. DIFICID treats only CDAD and should not be used to treat any other infection. Although it is common to feel better early in the course of therapy, DIFICID should be taken exactly as directed. Skipping doses or not taking all the medication as directed may: Decrease the effectiveness of DIFICID Increase the chances that the bacteria will become resistant and not be treatable by DIFICID or other drugs in the future If you do not see your healthcare providers wash their hands, please ask them to do so. Please see Important Safety Information on back cover and accompanying full prescribing information. What are the possible side effects associated with taking DIFICID? The most common adverse reactions are nausea, vomiting, abdominal pain, bleeding in the gastrointestinal tract, decrease in the number of red blood cells, and a low number of neutrophils (type of white blood cell). If you develop these or other signs and symptoms, please let your doctor or nurse know right away. What to know about Clostridium difficile–associated diarrhea (CDAD) What is Clostridium difficile-associated diarrhea (CDAD)? CDAD is diarrhea caused by a germ called Clostridium difficile, also known as C. difficile. Most cases of CDAD occur in patients taking, or who have recently taken, antibiotics for another illness. The most common symptoms of a C. difficile infection include: Watery diarrhea What to know about DIFICID What is DIFICID? DIFICID is a drug for the treatment of CDAD. It is prescribed to adults aged 18 and older. DIFICID treats only CDAD and should not be used to treat any other infection. You may be at risk of CDAD and its recurrence* if you: Are taking or have recently taken antibiotics for another illness Are aged 65 or older Were recently admitted to a hospital or other healthcare facility Fever Loss of appetite Nausea Belly pain and tenderness Have a weakened immune system Have had a prior CDAD episode *Recurrence means your symptoms come back after you finish your treatment. How do I take DIFICID? What can I do to help prevent the spread of CDAD? Make sure that all doctors, nurses, and other healthcare providers wash their hands with soap and water before and after caring for you Only take antibiotics exactly as directed by your doctor Be sure to wash your own hands often, especially after using the bathroom and before eating Visitors should wash their hands before they enter your room and as they leave your room Ask the nurse if visitors need to wear protective gowns and gloves when they visit you The dosage of DIFICID is one 200 mg tablet by mouth twice daily for 10 days. DIFICID may be taken with or without food. What important information should I know about DIFICID? DIFICID is contraindicated and should not be used in patients who are allergic to fidaxomicin. DIFICID treats only CDAD and should not be used to treat any other infection. Although it is common to feel better early in the course of therapy, DIFICID should be taken exactly as directed. Skipping doses or not taking all the medication as directed may: Decrease the effectiveness of DIFICID Increase the chances that the bacteria will become resistant and not be treatable by DIFICID or other drugs in the future If you do not see your healthcare providers wash their hands, please ask them to do so. Please see Important Safety Information on back cover and accompanying full prescribing information. What are the possible side effects associated with taking DIFICID? The most common adverse reactions are nausea, vomiting, abdominal pain, bleeding in the gastrointestinal tract, decrease in the number of red blood cells, and a low number of neutrophils (type of white blood cell). If you develop these or other signs and symptoms, please let your doctor or nurse know right away. What do I need to do when I get home from the hospital? Although you may be feeling better, there are a few things you should do to lower the chances of being infected again or spreading C. difficile to others. Take DIFICID exactly as prescribed by your doctor and pharmacist. Do not skip doses or stop before you finish taking all the tablets Wash your hands often, especially after going to the bathroom and before preparing food – People who live with you should wash their hands often, as well If your diarrhea comes back or gets worse after you get home, tell your doctor right away Follow your doctor’s instructions If you have any questions, please consult with your doctor or other healthcare professional. Important Safety Information IFICID is contraindicated in patients with D hypersensitivity to fidaxomicin DIFICID should not be used for systemic infections Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. In the event of a severe reaction, discontinue DIFICID Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria The most common adverse reactions reported in clinical trials are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%) This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088). Please see Important Safety Information above and accompanying full prescribing information. © 2013 Optimer Pharmaceuticals, Inc. Jersey City, NJ 07302 April 2013 20226 Frequently asked questions about DIFICID® (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) A guide for patients and caregivers Why has my doctor prescribed DIFICID? Your doctor has prescribed DIFICID to treat your CDAD. Continue taking DIFICID until your full course of therapy is complete. This brochure will provide answers to some common questions about CDAD and DIFICID. Be sure to talk with your healthcare provider if you have any questions about your illness or treatment. DIFICID is a prescription antibacterial drug used in adults 18 years or older to treat diarrhea caused by a certain bacteria called Clostridium difficile. DIFICID should be used only to treat bacterial infections that are caused by or strongly suspected to be caused by Clostridium difficile. Not taking DIFICID exactly as directed by your doctor may decrease its effectiveness or increase the chance that bacteria become resistant to DIFICID or other antibacterial drugs. Please see Important Safety Information on back cover and accompanying full prescribing information. What do I need to do when I get home from the hospital? Although you may be feeling better, there are a few things you should do to lower the chances of being infected again or spreading C. difficile to others. Take DIFICID exactly as prescribed by your doctor and pharmacist. Do not skip doses or stop before you finish taking all the tablets Wash your hands often, especially after going to the bathroom and before preparing food – People who live with you should wash their hands often, as well If your diarrhea comes back or gets worse after you get home, tell your doctor right away Follow your doctor’s instructions If you have any questions, please consult with your doctor or other healthcare professional. Important Safety Information IFICID is contraindicated in patients with D hypersensitivity to fidaxomicin DIFICID should not be used for systemic infections Acute hypersensitivity reactions (angioedema, dyspnea, pruritus, and rash) have been reported. In the event of a severe reaction, discontinue DIFICID Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria The most common adverse reactions reported in clinical trials are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%) This is not a complete list of all side effects. If you experience these or other symptoms, contact your healthcare professional right away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088). Please see Important Safety Information above and accompanying full prescribing information. © 2013 Optimer Pharmaceuticals, Inc. Jersey City, NJ 07302 April 2013 20226 Frequently asked questions about DIFICID® (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) A guide for patients and caregivers Why has my doctor prescribed DIFICID? Your doctor has prescribed DIFICID to treat your CDAD. Continue taking DIFICID until your full course of therapy is complete. This brochure will provide answers to some common questions about CDAD and DIFICID. Be sure to talk with your healthcare provider if you have any questions about your illness or treatment. DIFICID is a prescription antibacterial drug used in adults 18 years or older to treat diarrhea caused by a certain bacteria called Clostridium difficile. DIFICID should be used only to treat bacterial infections that are caused by or strongly suspected to be caused by Clostridium difficile. Not taking DIFICID exactly as directed by your doctor may decrease its effectiveness or increase the chance that bacteria become resistant to DIFICID or other antibacterial drugs. Please see Important Safety Information on back cover and accompanying full prescribing information.