Lubiprostone

WHY is this medicine prescribed?

Lubiprostone is used to relieve stomach pain, bloating, and straining and produce softer and more frequent bowel movements in people who have chronic idiopathic constipation (difficult or infrequent passage of stools that lasts for 3 months or longer and is not caused by a disease or a medication). Lubiprostone is also used to treat irritable bowel syndrome with constipation (IBS-C; a condition that causes stomach pain or cramps, bloating, and infrequent or difficult passage of stools) in women who are at least 18 years of age. Lubiprostone is also used to treat constipation caused by certain opioid (narcotic) pain medications in people with chronic (on-going), noncancer pain. Lubiprostone is in a class of medications called laxatives. It works by increasing the amount of fluid that flows into the bowel and allowing the stool to pass more easily.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Lubiprostone comes as a capsule to take by mouth. It is usually taken with food and water twice a day in the morning and evening. Take lubiprostone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lubiprostone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsule whole; do not open, chew, or crush it. Tell your doctor if you are unable to swallow the capsule.

Lubiprostone may help to relieve your symptoms but will not cure your condition. Continue to take lubiprostone even if you feel well. Do not stop taking lubiprostone without talking to your doctor. Your doctor will monitor your condition and will tell you when you should stop taking lubiprostone.

What SPECIAL PRECAUTIONS should I follow?

Before taking lubiprostone,

• tell your doctor and pharmacist if you are allergic to lubiprostone, any other medications, or any of the ingredients in lubiprostone capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: medications for high blood pressure and methadone (Dolophine, Methadose). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had a blockage in your stomach or bowels. If you do not know if you have a blockage in your stomach or bowels, your doctor will examine you to see whether you have this condition. If you have this type of blockage, your doctor will probably tell you not to take lubiprostone.

• tell your doctor if you have severe diarrhea or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You will need to have a negative pregnancy test before you begin to take lubiprostone. You must use birth control while taking this medication. Talk to your doctor about the method of birth control that is best for you. If you become pregnant while taking lubiprostone, call your doctor right away.

• tell your doctor if you are breastfeeding. If your breastfed child has diarrhea while you are taking lubiprostone, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Lubiprostone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• stomach pain or bloating
• gas
• vomiting
• heartburn
• headache
• dizziness
• swelling of the hands, feet, ankles, or lower legs
• chest discomfort
• tiredness

Some side effects can be serious. If you experience any of the following symptoms, stop taking lubiprostone and call your doctor immediately:

• severe diarrhea
• shortness of breath or difficulty taking in a breath
• chest tightness
• fainting
• lightheadedness
• rash
• swelling of the face, lips, mouth, tongue or throat
• throat tightness

Lubiprostone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea
• vomiting
• diarrhea
• dizziness
• headache
• stomach pain or discomfort
• flushing
• shortness of breath
• pale skin
• loss of appetite
• weakness
• chest discomfort
• dry mouth
• excessive sweating
• fainting

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.