Linaclotide is used to treat chronic constipation, or chronic irritable bowel syndrome (IBS) in people who have had constipation as the main symptom.

Linaclotide is also used to treat functional constipation (FC) in children and adolescents 6 to 17 years of age.

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

You should not use linaclotide if you have a blockage in your intestines.

Linaclotide is not approved for use by anyone younger than 6 years old.

Linaclotide should not be given to a child younger than 6 years old. Linaclotide can cause severe diarrhea and fatal dehydration in a child.

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

Take linaclotide in the morning on an empty stomach, at least 30 minutes before your first meal.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of applesauce or bottled water. Swallow the mixture right away without chewing. Do not save it for later use.

Even if you have taken this medicine with applesauce, wait at least 30 minutes before eating a full meal.

If needed, medicine from the linaclotide capsule may be given through a nasogastric (NG) or gastronomy tube.

Carefully follow instructions for mixing medicine from the capsule with applesauce or water, or giving the medicine through a feeding tube. Ask your doctor or pharmacist if you have any questions.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Keep this medicine out of the reach of children. Linaclotide can be fatal to a child who accidentally swallows this medicine. Seek emergency medical attention if this happens.

Usual Adult Dose for Irritable Bowel Syndrome with Constipation (IBS-C):

290 mcg orally once a day

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

Usual Adult Dose for Chronic Idiopathic Constipation (CIC):

145 mcg orally once a day

Use: Treatment of chronic idiopathic constipation (CIC)

Usual Pediatric Dose for Functional Constipation (FC):

72 mcg orally once a day

Use: Treatment of functional constipation (FC) in pediatric patients 6 to 17 years of age.

You should not use linaclotide if you are allergic to it, or if you have:

• a blockage in your intestines (bowel obstruction).

Linaclotide is not approved for use by anyone younger than 6 years old.

Linaclotide should not be given to a child younger than 2 years old. Linaclotide can cause severe diarrhea and severe dehydration in a child younger than 2 years old. Do not give linaclotide to any child or teenager without the advice of a doctor.

Tell your doctor if you are pregnant or breastfeeding.

Skip the missed dose and use your next dose at the regular time. Do not use 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.

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.

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

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.

Linaclotide may cause serious side effects. Stop using linaclotide and call your doctor at once if you have:

• severe or ongoing diarrhea; or

• diarrhea with dizziness or a light-headed feeling (like you might pass out).

Common side effects of linaclotide may include:

• diarrhea;

• stomach pain;

• gas; or

• bloating or full feeling in your stomach.

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.

Other drugs may affect linaclotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.