Constella (Linaclotide) belongs to the class of medications called guanylate cyclase-C agonists.

It is used to treat irritable bowel syndrome with Constipation (IBS-C) and to treat chronic (long-term) constipation. Constella (Linaclotide) works by increasing fluid in the digestive tract. This causes softening of the stools, increased speed of food and waste travelling through the digestive system, and increased frequency of bowel movements. It also helps reduce the discomfort that often occurs with long-term constipation by reducing the sensitivity of the pain-sensing nerves in the digestive system.

Symptoms often begin to improve within a week of starting to take Constella (Linaclotide), but it can take longer.

Constella (Linaclotide) may be available under multiple brand names and/or in several different forms. Any specific brand name of Constella (Linaclotide) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Constella (Linaclotide) may not be used for all of the conditions discussed here.

Your doctor may have suggested Constella (Linaclotide) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Constella (Linaclotide), speak to your doctor. Do not stop taking Constella (Linaclotide) without consulting your doctor.

Do not give Constella (Linaclotide) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Constella (Linaclotide) if their doctor has not prescribed it.

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The recommended adult dose of Constella (Linaclotide) to treat symptoms of irritable bowel syndrome with constipation is 290 µg taken once a day.

The recommended adult starting dose of Constella (Linaclotide) for chronic constipation is 145 µg taken once daily. Some people may be prescribed a dose of 72 µg taken once daily, depending on their response to the starting dose.

Constella (Linaclotide) should be taken on an empty stomach, at least 30 minutes before the first meal of the day. Do not crush or chew the capsules. Swallow the capsules whole with some water.

If you have trouble swallowing, the contents of the capsule may be sprinkled on applesauce or water. If you are using applesauce, sprinkle the contents of one capsule onto one teaspoon of applesauce and consume immediately. Do not chew the beads. Do not store for later use. If you are using water, open the capsule into a cup containing approximately 30 ml of bottled water. Gently swirl the beads and water for at least 20 seconds. Swallow the mixture. Add another 30 mL of water to the cup, swirl again for at least 20 seconds and swallow immediately. Do not store the bead and water mixture for later use. Note that this drug is coated on the surface of the beads, and the drug will dissolve into the water, but the beads will not dissolve. It is not necessary to consume all of the beads to get the full dose.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Constella (Linaclotide) be taken exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Constella (Linaclotide) at room temperature, in its original package. Protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Constella (Linaclotide). If you are concerned about side effects, discuss the risks and benefits of Constella (Linaclotide) with your doctor.

The following side effects have been reported by at least 1% of people taking Constella (Linaclotide). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bloating (swelling or feeling of fullness in your abdomen)
• Diarrhea
• nausea
• passing gas
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain

Stop taking the medication and seek immediate medical attention if any of the following occur:

• new or worsening abdominal pain
• severe diarrhea (persistent watery stools)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Constella (Linaclotide).

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72 µg
Each white-to-off-white, opaque, hard gelatin capsule, imprinted "FL 72" in grey and filled with linaclotide-coated beads, contains 72 µg of Constella (Linaclotide). Nonmedicinal ingredients: calcium chloride dihydrate, gelatin, hypromellose, iron oxide black, iron oxide yellow, microcrystalline cellulose, polyvinyl alcohol, shellac glaze, talc, and titanium dioxide.

145 µg
Each white-to-off-white, opaque, hard gelatin capsule, imprinted "FL 145" in grey and filled with linaclotide-coated beads, contains 145 µg of Constella (Linaclotide). Nonmedicinal ingredients: calcium chloride dihydrate, gelatin, hypromellose, iron oxide black, iron oxide yellow, L-leucine, microcrystalline cellulose, shellac glaze, and titanium dioxide.

290 µg
Each white-to-off-white, opaque, hard gelatin capsule, "FL 290" in grey and filled with linaclotide-coated beads, contains 290 µg of Constella (Linaclotide). Nonmedicinal ingredients: calcium chloride dihydrate, gelatin, hypromellose, iron oxide black, iron oxide yellow, L-leucine, microcrystalline cellulose, shellac glaze, and titanium dioxide.

Do not take Constella (Linaclotide) if you:

• are allergic to Constella (Linaclotide) or any ingredients of the medication
• have or may have a blockage in the digestive tract

Do not give Constella (Linaclotide) to children less than 6 years of age.

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Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Constella (Linaclotide).

Diarrhea: The most common side effect of Constella (Linaclotide) is diarrhea. If you develop severe, watery diarrhea, it may lead to dehydration, which can quickly become a medical emergency. If you experience severe diarrhea, stop taking Constella (Linaclotide) and contact your doctor as soon as possible.

Pregnancy: Constella (Linaclotide) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Constella (Linaclotide), contact your doctor immediately.

Breast-feeding: It is not known if Constella (Linaclotide) passes into breast milk. If you are a breast-feeding mother and are taking Constella (Linaclotide), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Constella (Linaclotide) have not been established for children. Children may be more likely to develop diarrhea and its potentially serious effects. Constella (Linaclotide) should not be given to children under the age of 6 years and it is not recommended for children and adolescents between 6 and 18 years of age.

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