Linaclotide Oral capsule

What is this medicine?

LINACLOTIDE (lin a KLOE tide) is used to treat irritable bowel syndrome (IBS) with constipation as the main problem. It may also be used for relief of chronic constipation.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• history of stool (fecal) impaction

• now have diarrhea or have diarrhea often

• other medical condition

• stomach or intestinal disease, including bowel obstruction or abdominal adhesions

• an unusual or allergic reaction to linaclotide, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Take on an empty stomach, at least 30 minutes before your first meal of the day. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

Overdosage: If you think you've taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, just skip that dose. Wait until your next dose, and take only that dose. Do not take double or extra doses.

What may interact with this medicine?

• certain medicines for bowel problems or bladder incontinence (these can cause constipation)

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. Tell your doctor if your symptoms do not get better or if they get worse.

Diarrhea is a common side effect of this medicine. It often begins within 2 weeks of starting this medicine. Stop taking this medicine and call your doctor if you get severe diarrhea.

Stop taking this medicine and call your doctor or go to the nearest hospital emergency room right away if you develop unusual or severe stomach-area (abdominal) pain, especially if you also have bright red, bloody stools or black stools that look like tar.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• black, tarry stools

• bloody or watery diarrhea

• new or worsening stomach pain

• severe or prolonged diarrhea

Side effects that usually do not require medical attention (Report these to your doctor or health care professional if they continue or are bothersome.):

• bloating

• gas

• loose stools

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medicine in the original container. Keep tightly closed in a dry place. Do not remove the desiccant packet from the bottle, it helps to protect your medicine from moisture. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.