Constella (Linaclotide)

CONSTELLA must not be used in children under 6 years of age and is not recommended for use in children and adolescents between 6 and 18 years of age. The safety and efficacy of CONSTELLA in children and adolescents (less than 18 years of age) have not been established.

BEFORE you use CONSTELLA talk to your doctor or pharmacist if:

• You have any other medical conditions.
• You are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if CONSTELLA will harm your unborn baby.
• You are breast-feeding or planning to breastfeed. It is not known if CONSTELLA passes into your breast milk. Talk with your doctor about the best way to feed your baby, if you take CONSTELLA.
• You are taking or planning to take any other medicines, including prescription and non-prescription drugs, vitamins and herbal supplements.

The most common side effects reported with CONSTELLA are:

• Diarrhea
• Passing gas
• Abdominal (stomach-area) pain
• Swelling, or a feeling of fullness or pressure in your abdomen (bloating)
• Nausea
• Vomiting

Some side effects can be serious.

Mild to moderate diarrhea often begins within the first two weeks of taking CONSTELLA. Stop taking CONSTELLA and call your doctor right away if you get severe diarrhea (for example persistent watery stools) during treatment with CONSTELLA.

Call your doctor or go to the nearest hospital emergency room right away, if you develop unusual or severe abdominal pain.

This is not a complete list of side effects. If you have other unexpected side effects, side effects that bother you or do not go away, contact your doctor or pharmacist.

As very little linaclotide is absorbed from the intestines, no drug interaction studies have been conducted with CONSTELLA.

Your doctor or pharmacist can tell you if it is safe to take CONSTELLA with your other medicines. Do not start or stop any medicine while taking CONSTELLA without talking to your healthcare provider first.

Usual adult dose:

• Take CONSTELLA exactly as your doctor tells you to take it.
• Take CONSTELLA one time each day on an empty stomach, at least 30 minutes before your first meal of the day.
• Swallow the capsule whole with water. Do not break the capsule apart or chew it.

If no improvement in symptoms is seen within 6 weeks, contact your doctor.

Overdose:

In case of drug overdose, contact a health care provider, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose of CONSTELLA, just skip that dose. Do not take two capsules to make up the missed dose. Instead, wait until the next time you are supposed to take it and then take your normal dose on an empty stomach, at least 30 minutes before your first meal of the day.