IMPORTANT SAFETY INFORMATION

INDICATIONS

RELISTOR^® (methylnaltrexone bromide) is a prescription medicine used to treat constipation in adults that is caused by prescription pain medicines called opioids.
RELISTOR tablets and RELISTOR injection are used to treat constipation caused by opioids in adults with long-lasting (chronic) pain that is not caused by active cancer.
RELISTOR injection is also used to treat constipation caused by opioids in adults with advanced illness or pain caused by active cancer and who need increases in their opioid dose for pain management.

IMPORTANT SAFETY INFORMATION

Do not take RELISTOR if you have a bowel blockage (called an intestinal obstruction) or have a history of bowel blockage.
RELISTOR can cause serious side effects such as a tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that is severe, does not go away, or gets worse, stop taking RELISTOR and get emergency medical help right away.
Stop using RELISTOR and call your healthcare provider if you get diarrhea that is severe or that does not go away during treatment with RELISTOR.
You may have symptoms of opioid withdrawal during treatment with RELISTOR including sweating, chills, diarrhea, stomach pain, anxiety, and yawning. Tell your healthcare provider if you have any of these symptoms.
Tell your healthcare provider if you have kidney or liver problems.
Tell your healthcare provider if you have any stomach or bowel (intestines) problems, including stomach ulcer, Crohn’s disease, diverticulitis, cancer of the stomach or bowel, or Ogilvie’s syndrome.
Tell your healthcare provider if you are pregnant or plan to become pregnant. Taking RELISTOR during pregnancy may cause opioid withdrawal symptoms in your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with RELISTOR.
Taking RELISTOR while you are breastfeeding may cause opioid withdrawal in your baby. You should not breastfeed during treatment with RELISTOR. You and your healthcare provider should decide if you will take RELISTOR or breastfeed. You should not do both.
Also, tell your healthcare provider about all of the medicines you take, including prescription and over the-counter medicines, vitamins, and herbal supplements.
In a clinical study, the most common side effects of RELISTOR tablets in people with long-lasting (chronic) pain that is not caused by cancer include: stomach-area (abdomen) pain, diarrhea, headache, swelling or a feeling of fullness or pressure in your abdomen, sweating, anxiety, muscle spasms, runny nose, and chills.
In a clinical study, the most common side effects of RELISTOR injection in people with long-lasting (chronic) pain that is not caused by cancer include: stomach-area (abdomen) pain, nausea, diarrhea, sweating, hot flush, tremor, and chills.
In clinical studies, the most common side effects of RELISTOR injection in people receiving treatment for their advanced illness include: stomach-area (abdomen) pain, gas, nausea, dizziness, and diarrhea.

You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center

Phone: 1-800-321-4576

Fax: 1-510-595-8183

Email: salixmc@dlss.com

Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.

INDICATIONS

RELISTOR^® (methylnaltrexone bromide) is a prescription medicine used to treat constipation in adults that is caused by prescription pain medicines called opioids.
RELISTOR tablets and RELISTOR injection are used to treat constipation caused by opioids in adults with long-lasting (chronic) pain that is not caused by active cancer.
RELISTOR injection is also used to treat constipation caused by opioids in adults with advanced illness or pain caused by active cancer and who need increases in their opioid dose for pain management.

IMPORTANT SAFETY INFORMATION

Do not take RELISTOR if you have a bowel blockage (called an intestinal obstruction) or have a history of bowel blockage.
RELISTOR can cause serious side effects such as a tear in your stomach or intestinal wall (perforation). Stomach pain that is severe can be a sign of a serious medical condition. If you get stomach pain that is severe, does not go away, or gets worse, stop taking RELISTOR and get emergency medical help right away.
Stop using RELISTOR and call your healthcare provider if you get diarrhea that is severe or that does not go away during treatment with RELISTOR.
You may have symptoms of opioid withdrawal during treatment with RELISTOR including sweating, chills, diarrhea, stomach pain, anxiety, and yawning. Tell your healthcare provider if you have any of these symptoms.
Tell your healthcare provider if you have kidney or liver problems.
Tell your healthcare provider if you have any stomach or bowel (intestines) problems, including stomach ulcer, Crohn’s disease, diverticulitis, cancer of the stomach or bowel, or Ogilvie’s syndrome.
Tell your healthcare provider if you are pregnant or plan to become pregnant. Taking RELISTOR during pregnancy may cause opioid withdrawal symptoms in your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with RELISTOR.
Taking RELISTOR while you are breastfeeding may cause opioid withdrawal in your baby. You should not breastfeed during treatment with RELISTOR. You and your healthcare provider should decide if you will take RELISTOR or breastfeed. You should not do both.
Also, tell your healthcare provider about all of the medicines you take, including prescription and over the-counter medicines, vitamins, and herbal supplements.
In a clinical study, the most common side effects of RELISTOR tablets in people with long-lasting (chronic) pain that is not caused by cancer include: stomach-area (abdomen) pain, diarrhea, headache, swelling or a feeling of fullness or pressure in your abdomen, sweating, anxiety, muscle spasms, runny nose, and chills.
In a clinical study, the most common side effects of RELISTOR injection in people with long-lasting (chronic) pain that is not caused by cancer include: stomach-area (abdomen) pain, nausea, diarrhea, sweating, hot flush, tremor, and chills.
In clinical studies, the most common side effects of RELISTOR injection in people receiving treatment for their advanced illness include: stomach-area (abdomen) pain, gas, nausea, dizziness, and diarrhea.

You are encouraged to report side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:

Salix Product Information Call Center

Phone: 1-800-321-4576

Fax: 1-510-595-8183

Email: salixmc@dlss.com

Please click here for full Prescribing Information for RELISTOR tablets and RELISTOR injection.

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