Linaclotide

Linaclotide is used to treat ongoing stomach and bowel issues, including:

• irritable bowel syndrome with constipation (which can cause belly pain and constipation) in adults and children 7 years and older;
• chronic idiopathic constipation (long-lasting constipation with no known cause) in adults; and
• functional constipation (long-lasting constipation not caused by a disease) in children 6 years and older.

Linaclotide may also be used for other reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Linaclotide is usually taken once per day on an empty stomach, at least 30 minutes before a meal, at about the same time each day.

Swallow the capsule whole. Do not crush or chew the capsule or its contents.

If you cannot swallow the capsule whole, you may open it and sprinkle the beads on applesauce or mix them with bottled water. Swallow right away. Do not chew the beads. Do not save the mixture for later. Do not mix the beads with other foods or liquids.

If you take linaclotide with applesauce or mixed with water, wait at least 30 minutes before you eat a meal.

Linaclotide may also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if your symptoms do not improve, or if they get worse.

Linaclotide may cause severe diarrhea. This can lead to dehydration (losing too much body water). Stop taking linaclotide and call your doctor right away if you get severe diarrhea.

Store at room temperature away from moisture and heat. Keep the capsules in their original container, along with the packet or canister of moisture-absorbing preservative.

Keep linaclotide out of the reach of children. If a child swallows linaclotide by accident, it may cause severe diarrhea and severe dehydration. Get emergency medical help right away.

You should not use linaclotide if you have a blockage in your intestines.

Do not give linaclotide to a child who is less than 2 years old. Linaclotide can cause severe diarrhea and life-threatening dehydration in young children.

You should not use linaclotide if you are allergic to it, or if you have:

• a blockage in your intestines (bowel obstruction).

Do not give linaclotide to children younger than 2 years old, even by accident. It can cause severe diarrhea and severe dehydration.

Tell your doctor if you are pregnant or plan to become pregnant, or if you are breastfeeding or plan to breastfeed.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Linaclotide may cause serious side effects. Stop using linaclotide and call your doctor right away if you have:

• severe stomach pain, especially if you also have blood in your stool or black stools that look like tar;
• severe or ongoing diarrhea; or
• diarrhea with dizziness or a light-headed feeling (like you might pass out).

Common side effects of linaclotide may include:

• bloating, gas;
• diarrhea;
• stomach pain; or
• swelling, or a feeling of fullness or pressure in your stomach area.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Skip the missed dose and take your next dose at the regular time. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any limits on food, drinks, or activities.

Other drugs may affect linaclotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.