Tenapanor is used in adults to treat irritable bowel syndrome with constipation.

Tenapanor may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Tenapanor is taken by mouth (1 tablet) twice a day.

Tenapanor should be taken immediately before breakfast or first meal of the day and immediately before dinner.

Store this medicine tightly closed in the original container at room temperature away from moisture and heat. Do not remove the canister of moisture-absorbing preservative from the original container.

Usual Adult Dose for Constipation:

50 mg orally 2 times a day

Use: Treatment of irritable bowel syndrome with constipation (IBS-C)

Usual Adult Dose for Irritable Bowel Syndrome:

50 mg orally 2 times a day

Use: Treatment of irritable bowel syndrome with constipation (IBS-C)

You should not use tenapanor if you have:

• a bowel blockage.

Tenapanor should not be used in children who are younger than 6 years.

Ask a doctor or pharmacist before using tenapanor if you have health problems.

Tell your doctor if you are pregnant, plan to get pregnant, or breastfeeding.

Skip the missed dose and take the next dose at the regular time. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (drying agent) from the bottle, if one has been provided.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking tenapanor and call your doctor at once if you have:

• severe diarrhea.

Common side effects of tenapanor may include:

• gas, diarrhea;

• feeling of fullness or pressure in your abdomen; or

• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.