What is TRULANCE?
TRULANCE is a prescription medicine used in adults to treat:

• a type of constipation called chronic idiopathic constipation (CIC). Idiopathic means the cause of the constipation is unknown.
• irritable bowel syndrome with constipation (IBS-C).

It is not known if TRULANCE is safe and effective in children less than 18 years of age.

Who should not take TRULANCE?

• Do not give TRULANCE to children who are less than 6 years of age.
• Do not take TRULANCE if a doctor has told you that you have a bowel blockage (intestinal obstruction).

Before taking TRULANCE, tell your doctor about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if TRULANCE will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Talk with your doctor about the best way to feed your baby if you take TRULANCE.

Tell your doctor about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

• Place the TRULANCE tablet in a clean cup with 1 ounce (30 mL) of room temperature water.
• Gently swirl the TRULANCE tablet and water for at least 15 seconds. The TRULANCE tablet will fall apart in the water.
• Flush the nasogastric or gastric feeding tube with 1 ounce (30 mL) of water.
• Draw up the TRULANCE tablet and water mixture into a catheter tip syringe and give right away through the nasogastric or gastric feeding tube. Do not keep the mixture for future use.
• If you see any part of the tablet left in the cup, add another 1 ounce (30 mL) of water to the cup, swirl for at least 15 seconds and use the same catheter tip syringe to give the mixture through the nasogastric or gastric feeding tube.
• Using the same or another catheter tip syringe, flush the nasogastric or gastric feeding tube with at least 10 mL of water.

What are the possible side effects of TRULANCE?

TRULANCE can cause serious side effects, including:

• See “What is the most important information I should know about TRULANCE?”
• Diarrhea is the most common side effect of TRULANCE, and it can sometimes be severe.
• Diarrhea often begins within the first 4 weeks of TRULANCE treatment.

Stop taking TRULANCE and call your doctor if you develop severe diarrhea.
These are not all the possible side effects of TRULANCE.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store TRULANCE?

• Store TRULANCE at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep TRULANCE in a secure place and in the bottle that it comes in.
• The TRULANCE bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle.
• The TRULANCE bottle contains a polyester coil to help protect the tablets during shipping. Remove the polyester coil from the bottle and throw it away after opening the bottle.
• Keep the container of TRULANCE tightly closed and in a dry place.
• Safely throw away TRULANCE that is out of date or no longer needed.

Keep TRULANCE and all medicines out of the reach of children.

• General information about the safe and effective use of TRULANCE.
  Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TRULANCE for a condition for which it was not prescribed. Do not give TRULANCE to other people, even if they have the same symptoms that you have. It may harm them.
  You can ask your doctor or pharmacist for information about TRULANCE that is written for health professionals.