Ibsrela

Ibsrela is a prescription medicine used in adults to treat:

• Irritable bowel syndrome with constipation (IBS-C).
• lowering of phosphorus levels in the blood of adults with chronic kidney disease (CKD) on dialysis who cannot use or do not respond well to phosphate binders.

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

• 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 you are on dialysis, do not take your dose right before a hemodialysis session. Take it right before the next meal following dialysis.
• 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. 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.

• 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 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, although this medicine is not expected to pass into your breast milk and to harm your baby. Talk with your doctor about the best way to feed your baby if you take this medicine.

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

Do not use stool softeners or laxatives with this medicine. If you take sodium polystyrene sulfonate, take it at least 3 hours apart from this medicine.

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.

• Store Ibsrela tablets at room temperature, between 68°F and 77°F (20°C and 25°C).
• Keep the tablets in the original container and protect from moisture. Keep the container tightly closed and in a dry place.
• Do not put the tablets in another container (repackage).
• The Ibsrela bottle contains a desiccant canister to help keep your medicine dry (protect it from moisture). Do not remove the desiccant from the bottle.

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

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

Active ingredient: tenapanor hydrochloride

Inactive ingredients: colloidal silicon dioxide, hypromellose, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, propyl gallate, stearic acid, tartaric acid, titanium dioxide, and triacetin.