SIDE EFFECTS: Diarrhea, bloating, gas, or stomach/abdominal pain/discomfort may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Stop taking this medication and tell your doctor right away if you have any serious side effects, including: severe diarrhea. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking linaclotide and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth on an empty stomach as directed by your doctor, usually once daily at least 30 minutes before your first meal of the day. Swallow the capsules whole. Do not break or chew the capsules. If you have trouble swallowing the capsule, it may be opened and the contents mixed in a teaspoonful of applesauce. Swallow the mixture right away, without chewing it. Do not save the mixture for future use. You may also empty the capsule's content into an ounce (30 milliliters) of water. Swirl the mixture for 20 seconds and drink right away, without chewing it. Add another ounce (30 milliliters) of water to the cup, swirl for 20 seconds and drink right away to get your whole dose. The water mixture may also be given through a tube into the stomach (nasogastric or gastric tube). If you are giving this medication through a tube, ask your health care professional for detailed instructions on how to give it. The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Tell your doctor if your condition does not improve or if it worsens.

PRECAUTIONS: Before taking linaclotide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal blockage. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. A product that may interact with this drug is: pramlintide.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.