What is the most important information I should know about LINZESS?

■Do not give LINZESS to children who are under 6 years of age. It may harm them.
■You should not give LINZESS to children 6 to 17 years of age. It may harm them.
See the section “What are the possible side effects of LINZESS?” for more information about side effects.

What is LINZESS?

LINZESS is a prescription medication used in adults to treat

■irritable bowel syndrome with constipation (IBS-C)
■a type of constipation called chronic idiopathic constipation (CIC). “Idiopathic” means the cause of the constipation is unknown.
It is not known if LINZESS is safe and effective in children.

Who should not take LINZESS?

■Do not give LINZESS to children who are under 6 years of age.
■Do not take LINZESS if a doctor has told you that you have a bowel blockage (intestinal obstruction).
What should I tell my doctor before taking LINZESS?

Before you take LINZESS, tell your doctor if you:

■have any other medical conditions
■are pregnant or plan to become pregnant. It is not known if LINZESS will harm your unborn baby.
■are breastfeeding or plan to breastfeed. It is not known if LINZESS passes into your breast milk. Talk with your doctor about the best way to feed your baby, if you take LINZESS.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

How should I take LINZESS?

■Take LINZESS exactly as your doctor tells you to take it.
■Take LINZESS one time each day on an empty stomach, at least 30 minutes before your first meal of the day.
■Swallow LINZESS capsules whole. Do not break or chew the capsules.
What are the possible side effects of LINZESS?

LINZESS can cause serious side effects, including:

■See “What is the most important information I should know about LINZESS?”
■Diarrhea is the most common side effect of LINZESS, and it can sometimes be severe.
■Diarrhea often begins within the first 2 weeks of LINZESS treatment.
■Stop taking LINZESS and call your doctor right away if you get severe diarrhea during treatment with LINZESS.
Other common side effects of LINZESS include:

■gas
■stomach-area (abdomen) pain
■swelling, or a feeling of fullness or pressure in your abdomen (distention)
Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of LINZESS. For more information, ask your doctor or pharmacist.

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

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store LINZESS?

■Store LINZESS at room temperature between 68°F to 77°F (20°C to 25°C).
■Keep LINZESS in the bottle that it comes in.
■The LINZESS bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle.
■Keep the container of LINZESS tightly closed and in a dry place.
Keep LINZESS and all medicines out of the reach of children.

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