Alli

Name: Alli

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Alli Dosage

Alli comes as a capsule and is usually taken three times a day with each meal that contains fat.

Take this medicine during a meal or up to one hour after a meal.

Skip your dose if you miss a meal or if a meal you consume doesn't contain fat.

Follow the instructions on your product label carefully when taking Alli. Don't take more or less of the drug than is recommended.

Alli Overdose

If you suspect an overdose, contact a poison control center or emergency room immediately.

You can get in touch with a poison control center at (800) 222-1222.

Missed Dose of Alli

If you miss a dose of Alli, take it as soon as you remember unless it's more than one hour since you consumed a main meal.

If it's longer than one hour since your meal, skip the missed dose and continue on your regular schedule.

Don't double up on doses to make up for a missed one.

What are the side effects of orlistat?

The most common side effects of orlistat are:

  • oily spotting on underwear,
  • flatulence,
  • urgent bowel movements,
  • fatty or oily stools,
  • increased number of bowel movements,
  • abdominal pain or discomfort, and
  • inability to control stool (incontinence).

From 1 in 250 and 1 in 70 patients experienced one or more of these symptoms in the first year. Generally, the side effects occurred within three months of starting therapy. In about 50% of patients, the side effects resolved within one to four weeks, but the effects in some patients lasted six months or longer. To reduce the occurrence of these side effects, meals should contain no more than 30% fat because it is the unabsorbed fat that causes most of the symptoms. alli causes fewer side effects because it contains half the dose of prescription-strength orlistat. Patients receiving orlistat with a history of oxalate kidney stones may develop increased levels of oxalate in their urine, which may increase the risk of kidney stones.

Liver failure has been reported in patients treated with orlistat. Orlistat should be discontinued if symptoms of liver failure (loss of appetite, anorexia, itching, jaundice, dark urine, light colored stools, or right upper abdominal pain) occur while taking orlistat.

Other serious side effects of orlistat include:

  • Serious allergic reactions
  • Angioedema
  • Deficiency in fat-soluble vitamins

Alli Precautions

You should not use Alli if you:

  • consistently have problems absorbing food (chronic malabsorption); or
  • have gallbladder problems; or
  • are pregnant or are breastfeeding a child; or
  • have ever had an allergic reaction to Alli or any of the inactive ingredients in Alli

Alli has been shown to reduce the absorption of certain vitamins. You should take a multivitamin containing vitamins D, E, K, and beta-carotene once a day at least 2 hours before or after the administration of Alli, such as at bedtime.

Some patients taking Alli may develop an increased risk for the development of kidney stones. Promptly report any symptoms of back pain or blood in the urine.

Some patients prescribed Alli may already be at increased risk for the formation of gall stones. Weight loss with Alli can increase the risk of gall stones. Promptly report any symptoms of pain in the upper right portion of the abdomen. The pain may be accompanied by nausea and vomiting.

There have been rare reports of severe liver injury in patients taking Alli. Promptly discontinue Alli and contact your healthcare provider if you develop symptoms suggestive of liver impairment, such as loss of appetite, itching, yellowing of the skin, dark urine, light colored stools, or right upper quadrant pain.

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

Do not take orlistat if you are pregnant. Weight loss is not recommended during pregnancy.

You should not use orlistat if you have a digestive disorder (problems absorbing food). You should not use Xenical if you have gallbladder problems, or if you are pregnant. Do not use alli if you have had an organ transplant, if you use cyclosporine, or if you are not overweight.

Precautions While Using Alli

It is very important that your doctor check your or your child's progress at regular visits, to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

For patients with diabetes: Weight loss may result in an improvement in your condition, and your doctor may need to change your dose of oral diabetes medicine or insulin.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Stop using this medicine and check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual itching; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may increase your risk of having kidney stones. Check with your doctor right away if you or your child have blood in the urine, nausea and vomiting, pain in the groin or genitals, or sharp back pain just below the ribs.

Weight loss with this medicine may increase your risk of having gallstones. Check with your doctor right away if you or your child have severe stomach pain with nausea and vomiting.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Uses of Alli

  • It is used to help you lose weight.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of gallstones like sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; or fever with chills.
  • Black, tarry, or bloody stools.
  • Pain when passing urine.
  • Passing urine more often.
  • Very bad back pain.
  • Very bad groin or thigh pain.
  • Swelling in the arms or legs.
  • Very upset stomach or throwing up.
  • Very bad belly pain.

What are some other side effects of Alli?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Loose stools (diarrhea).
  • Not able to control stools.
  • Gas with discharge, oily spotting, and feeling the need to go to the bathroom.
  • Belly pain.
  • Upset stomach.
  • Headache.
  • Back pain.
  • Feeling tired or weak.
  • Period (menstrual) changes.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Alli, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Alli (orlistat). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Alli.

Review Date: October 4, 2017

Purpose

Weight loss aid

Questions or comments?

Call toll-free 1-800-671-2554 (English/Spanish) weekdays (10:00am - 4:30pm EST)

For more information and to learn more about Alli, visit us at www.MyAlli.com.

To get information in Spanish, please call toll-free 1-877-469-2554.

TAMPER- EVIDENT features for your protection. The bottle of capsules has a foil seal under the cap imprinted with the words "sealed for your protection". Each individual capsule is sealed with a dark blue band around the center of the capsule. DO NOT USE THIS PRODUCT IF ANY OF THESE TAMPER-EVIDENT FEATURES ARE MISSING, TORN OR BROKEN.

Alli, MyAlli.com, MyAlliPlan.com, Alli Shuttle and various design elements are trademarks of GlaxoSmithKline.

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

US Patent Nos. 4,598,089

6,004,996

Shuttle Patent Pending

© 2007 GlaxoSmithKline

What is alli?

alli (orlistat) blocks some of the fat that you eat, keeping it from being absorbed by your body.

alli is used to aid in weight loss, or to help reduce the risk of regaining weight already lost. This medicine must be used together with a reduced-calorie diet. Orlistat is for use only in adults.

Xenical is the prescription-strength form of orlistat. The alli brand of orlistat is available without a prescription.

In Summary

Common side effects of Alli include: bowel urgency, frequent bowel movements, oily evacuation, oily rectal leakage, steatorrhea, and flatulence with discharge. Other side effects include: fecal incontinence. See below for a comprehensive list of adverse effects.

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