Linaclotide Capsules

What is this medication?

LINACLOTIDE (lin a KLOE tide) treats irritable bowel syndrome (IBS) with constipation. It may also treat chronic constipation. It works by softening the stool, making it easier to have a bowel movement.

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

COMMON BRAND NAME(S): Linzess

What should I tell my care team before I take this medication?

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

• Diarrhea
• History of blockage in your bowels
• History of stool (fecal) impaction
• An unusual or allergic reaction to linaclotide, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medication. Swallow the capsules whole. Take it on an empty stomach, at least 30 minutes before your first meal of the day. Keep taking it unless your care team tells you to stop.

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 care team about the use of this medication in children. It is not approved for use in children.

Overdosage: If you think you have 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, skip it. Take your next dose at the normal time. Do not take extra or 2 doses at the same time to make up for the missed dose.

What may interact with this medication?

• Interactions have not been studied.

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 medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

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

Stop taking this medication and call your care team or go to the nearest hospital emergency room right away if you develop unusual or severe stomach 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 medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Bloating
• Diarrhea
• Gas
• Stomach pain

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 medication?

Keep out of the reach of children and pets.

Store at room temperature at 25 degrees C (77 degrees F). Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.