Linaclotide, Oral

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KEY POINTS

• This medicine is taken by mouth to treat irritable bowel syndrome or constipation that has lasted more than 6 months. Take it exactly as directed.
• Keep all appointments for blood tests or exams.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: guanylate cyclase-C agonist; laxative

Generic and brand names: linaclotide, oral; Linzess

What is this medicine used for?

This medicine is taken by mouth to treat chronic idiopathic constipation (constipation with no known cause that has lasted more than 6 months). This medicine is also used to treat irritable bowel syndrome with constipation in adults over 18 years of age.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, or ulcerative colitis

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine as directed by your healthcare provider. Do not take more or take it more often than directed.

Check with your healthcare provider before using in children under age 18. Do not give this medicine to children under 6 years of age.

Take this medicine at least 30 minutes before you eat in the morning. It must be taken on an empty stomach. Swallow the capsule whole with a full glass of water.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: diarrhea, stomach pain.

What should I watch out for?

Do not give this medicine to children under 6 years of age. It may cause serious side effects or death. Ask your provider before giving this medicine to children 6 to 17 years of age.

Diarrhea is a common side effect of this medicine. If you develop severe diarrhea while you are taking this medicine, contact your healthcare provider. Do not treat yourself by taking nonprescription products for diarrhea.

You will need to have checkups regularly to see how this medicine affects you. Keep all appointments.

Contact your healthcare provider if your condition does not improve or if it gets worse.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe diarrhea, severe stomach pain, bloody bowel movements, rectal bleeding.

Other: Stuffy or runny nose, headache, bloating, nausea, gas.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. Keep the medicine in the original container that it came in. Do not remove the desiccant package from the container. The desiccant package will help keep the medicine dry.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.