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US Brand Names

Description

Linaclotide is used to treat irritable bowel syndrome with constipation (IBS-C). It is also used to treat chronic idiopathic constipation (CIC).

Linaclotide works by increasing intestinal fluid secretion, which helps ease the passage of stool and helps relieve the symptoms associated with constipation.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

• Capsule

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Linaclotide should not be given to children younger than 6 years of age. Use in children 6 to 17 years of age is not recommended. This medicine could be harmful to children.

Geriatric

Although appropriate studies on the relationship of age to the effects of linaclotide have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Stomach or bowel blockage, or history of—Should not be used in patients with these conditions.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine on an empty stomach, at least 30 minutes before breakfast or the first meal of the day.

Swallow the capsule whole. Do not crush, break, or chew it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For chronic idiopathic constipation (CIC):
    • Adults—145 micrograms (mcg) once a day.
    • Children—Use is not recommended.
  • For irritable bowel syndrome with constipation (IBS-C):
    • Adults—290 micrograms (mcg) once a day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Stop using this medicine and call your doctor right away if you have severe diarrhea.

If your symptoms and condition do not improve within a few days, or if they become worse, check with your doctor.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• Severe diarrhea

• Heartburn
• Loss of appetite
• Nausea
• Vomiting
• Weakness

• Bleeding from the rectum
• Bloody, black, or tarry stools
• Confusion
• Cough
• Decreased urination
• Difficulty swallowing
• Dizziness
• Dry mouth
• Fainting
• Fast heartbeat
• Hives or welts
• Increase in heart rate
• Itching
• Lightheadedness
• Loss of bowel control
• Puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• Rapid breathing
• Redness of the skin
• Shortness of breath
• Skin rash
• Sunken eyes
• Thirst
• Tightness in chest
• Unusual tiredness or weakness
• Wheezing
• Wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Body aches or pain
• Chills
• Difficulty in breathing
• Ear congestion
• Excess air or gas in the stomach or intestines
• Fever
• Full or bloated feeling
• Headache
• Loss of voice
• Passing gas
• Sneezing
• Sore throat
• Stuffy or runny nose

• Acid or sour stomach
• Belching
• Indigestion
• Pain or tenderness around the eyes and cheekbones
• Pressure in the stomach
• Stomach discomfort or upset
• Swelling of abdominal or stomach area

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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