Linaclotide

IMPORTANT WARNING:

Linaclotide is used in adults to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools) and chronic idiopathic constipation (CIC; difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication). Linaclotide is in a class of medications called guanylate cyclase-C agonists. It works by increasing the movement of food and waste through the stomach and intestines and by blocking pain signals in the intestines.

Linaclotide comes as a capsule to take by mouth. It is usually taken once a day on an empty stomach, at least thirty minutes before the first meal of the day. Take linaclotide at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take linaclotide exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

Linaclotide controls the symptoms of IBS-C and CIC, but does not cure these conditions. Your constipation symptoms may improve in 1 week, and it may take slightly longer for your stomach pain to improve. Continue to take linaclotide even if you feel well. Do not stop taking linaclotide without talking to your doctor. If you stop taking linaclotide, your symptoms may return in about 1 week.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking linaclotide,

• tell your doctor and pharmacist if you are allergic to linaclotide, any other medications, or any of the ingredients in linaclotide capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have a blockage in your stomach or intestines. Your doctor will probably tell you not to take linaclotide.
• tell your doctor if you have or have ever had any other medical conditions.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking linaclotide, call your doctor.

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

If you remember the missed dose before eating, take the missed dose as soon as you remember it. If you have already eaten, check with your doctor before taking the missed dose. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Linaclotide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea

• stomach pain

• swelling or feeling of fullness or pressure in the stomach area

• gas

• headache

Some side effects can be serious. If you experience any of these symptoms, stop taking linaclotide and call your doctor immediately or get emergency medical treatment:

• unusual or severe stomach pain

• bright red or black, tarry stools

• hives

Linaclotide may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

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. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• diarrhea

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.

Last Revised - 02/15/2013