Ibsrela is a prescription medicine used in adults to treat:

• Irritable bowel syndrome with constipation (IBS-C).

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

• Do not give Ibsrela to children who are less than 6 years of age. It may harm them.
• You should not give Ibsrela to patients 6 years to less than 18 years of age. It may harm them.

Ibsrela can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).

See Ibsrela side effects for more information about side effects.

• Take Ibsrela exactly as your doctor tells you to take it.
• Take one Ibsrela tablet by mouth, two times each day.
• Take the tablets immediately before breakfast or the first meal of the day and immediately before dinner.
• If a dose is missed, skip the missed dose and take the next dose at the regular time. Do not take two doses at the same time.

• Do not give Ibsrela to children who are less than 6 years of age. Ibsrela can cause severe diarrhea and your child could get severe dehydration (loss of a large amount of body water and salt).
• Do not take Ibsrela if a doctor has told you that you have a bowel blockage (intestinal obstruction).

Before taking Ibsrela

Before you take Ibsrela, tell your doctor about all your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take Ibsrela.

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

Ibsrela can cause serious side effects, including:

• See Important information
• Diarrhea is the most common side effect of Ibsrela, and it can sometimes be severe. Stop taking Ibsrela and call your doctor if you develop severe diarrhea.

The other most common side effects include:

• swelling, or a feeling of fullness or pressure in your abdomen (distension).
• gas (flatulence).
• dizziness.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch.