IMPORTANT SAFETY INFORMATION
- Do not give Trulance to children who are less than 6 years of age. It may harm them.
- You should not give Trulance to children 6 years to less than 18 years of age. It may harm them.
- Do not take Trulance if a doctor has told you that you have a bowel blockage (intestinal obstruction).
Diarrhea is the most common side effect and can sometimes be severe. Diarrhea often begins within the first 4 weeks of Trulance treatment. Stop taking Trulance and call your doctor right away if you get severe diarrhea.
Before you take Trulance, tell your doctor:
- If you have any other medical conditions.
- If you are pregnant or plan to become pregnant. It is not known if Trulance will harm your unborn baby.
- If you are breastfeeding or plan to breastfeed. It is not known if Trulance passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take Trulance.
- About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Trulance. For more information, ask your doctor or pharmacist.
You are encouraged to report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or you can report side effects to Synergy Pharmaceuticals at 1-888-869-8869.
Please also see Medication Guide within the full Prescribing Information.