Alli

• The blood thinning effect of warfarin (Coumadin, Jantoven) depends on the amount of vitamin K in the body, and vitamin K is one of the vitamins that binds to fat. Patients receiving warfarin who begin orlistat should have their blood clotting monitored closely because the orlistat may cause levels of vitamin K to decline. This will increase the effects of warfarin and lead to abnormal bleeding from the warfarin. There is no evidence that a deficiency of vitamin K occurs in patients who are taking orlistat.
• Orlistat may reduce the absorption and blood levels of cyclosporine (Sandimmune) when both drugs are administered together. Therefore, cyclosporine should be administered two hours before or after orlistat, and more frequent monitoring of cyclosporine levels may be needed.
• Hypothyroidism has been reported when orlistat and levothyroxine (Synthroid, Levoxyl, Levothroid, Unithroid) were combined. Patients treated with both orlistat and levothyroxine should be monitored for changes in thyroid function. The orlistat and levothyroxine should be taken at least four hours apart.

Capsules: 60 mg (alli), 120 mg (Xenical)

Capsules should be stored at room temperature, 15 C - 30 C (59 F - 86 F)

Alli is an over the counter medication for weight loss. Alli belongs to a group of drugs called lipase inhibitors, which work by preventing the absorption of fat in your body. 

Because Alli works by blocking the absorption of dietary fat, it is likely that you will experience some changes in bowel habits. These generally occur during the first weeks of treatment; however, they may continue throughout your use of Alli.
These changes may include

• oily spotting
• gas with discharge
• urgent need to go to the bathroom
• oily or fatty stools 
• an oily discharge
• increased number of bowel movements
• an inability to control bowel movements 
• Due to the presence of undigested fat, the oil seen in a bowel movement may be clear or have a coloration such as orange or brown.

These bowel changes are a natural effect of blocking the fat from being absorbed and indicate that Alli is working. They generally occur early in treatment, particularly after meals containing higher amounts of fat than are recommended. These symptoms are often temporary and may lessen or disappear as you continue treatment and keep to your recommended diet of meals containing no more than about 30% fat. However, these side effects may occur in some individuals over a period of 6 months or longer.

• In obese adolescent patients treated with Alli, the side effects reported were similar to those observed in adults.
• If you are concerned about these or any other side effects you experience while taking Alli, talk to your doctor or pharmacist.

Be sure to discuss with your doctor all medications (including herbal products) you are currently taking, including medicines you can get without a prescription (over-the-counter), to determine if Alli can be taken in addition to these medications.

• If you are taking cyclosporine, Alli and cyclosporine should be taken at least 2 hours apart.
• If your cyclosporine levels are being measured, more frequent monitoring may be necessary. 
• If you are taking levothyroxine, orlistat and levothyroxine should be taken at least 4 hours apart.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Alli is excreted in human breast milk or if it will harm your nursing baby.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never share orlistat with another person, especially someone with a history of eating disorders.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Orlistat is usually taken 3 times per day with each main meal that contains some fat (no more than 30% of the calories for that meal). You may take the medicine either with your meal or up to 1 hour after eating.

If you skip a meal or you eat a meal that does not contain any fat, skip your orlistat dose for that meal.

The fat content of your daily diet should not be greater than 30% of your total daily caloric intake. For example, if you eat 1200 calories per day, no more than 360 of those calories should be in the form of fat.

Read the label of all food items you consume, paying special attention to the number of servings per container. Your doctor, nutrition counselor, or dietitian can help you develop a healthy eating plan.

Orlistat is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Orlistat can make it harder for your body to absorb certain vitamins, and you may need to take a vitamin and mineral supplement while you are taking orlistat. Follow your doctor's instructions about the type of supplement to use. Take the supplement at bedtime, or at least 2 hours before or after you take orlistat.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed. Throw away any unused orlistat after the expiration date on the medicine label has passed.

Keep track of your medicine. Orlistat is a drug that may be misused as a weight-loss aid, and you should be aware if anyone is using your medicine improperly or without a prescription.

Orlistat is used together with a reduced-calorie diet to help you lose weight and to help keep the lost weight from returning. It is also used in overweight people who may also have diabetes, high blood pressure, high cholesterol, or heart disease.

Orlistat works by keeping your intestines from absorbing some of the fats from the food that you eat. The undigested fat goes out of your body in your bowel movements.

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

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:

• Bladder pain
• body aches
• chills
• cough
• diarrhea
• difficulty with breathing
• ear congestion
• fever
• general feeling of discomfort or illness
• headache
• loss of appetite
• loss of voice
• lower back or side pain
• muscle aches and pains
• nasal congestion
• nausea
• runny nose
• shivering
• sneezing
• sore throat
• sweating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

• Tightness in the chest
• tooth or gum problems
• troubled breathing
• wheezing

• Bloody or cloudy urine
• change in hearing
• contagious diarrhea
• dark urine
• difficult or painful urination
• earache
• fast heartbeat
• frequent urge to urinate
• general tiredness and weakness
• hives
• hoarseness
• irritation
• itching
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• noisy breathing
• pain in the ears
• rash
• redness of the skin
• shortness of breath
• skin blisters
• swelling of the eyelids, face, lips, hands, or feet
• troubled swallowing
• upper right abdominal or stomach pain
• yellow eyes and skin

• Anxiety
• bloating
• blurred vision
• cold sweats
• coma
• confusion
• constipation
• cool, pale skin
• depression
• dizziness
• dry skin and hair
• feeling cold
• hair loss
• hoarseness or husky voice
• increased hunger
• indigestion
• loss of appetite
• muscle cramps and stiffness
• nervousness
• nightmares
• pains in the stomach, side, or abdomen, possibly radiating to the back
• seizures
• weight gain

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:

• Abdominal or stomach pain or discomfort
• back pain
• difficulty with moving
• gas with leaky bowel movements
• inability to hold bowel movement
• increases in bowel movements
• loss of bowel control
• oily bowel movements
• oily spotting of underclothes

• Itching of the vagina or genital area
• menstrual changes
• pain during sexual intercourse
• rectal pain or discomfort
• thick, white vaginal discharge with no odor or with a mild odor

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.

Organ transplant alert:

do not use if you have had an organ transplant. Orlistat interferes with the medicines used to prevent transplant rejection.

Allergy alert:

do not use if you are allergic to any of the ingredients in orlistat capsules

Do not use

• if you are taking cyclosporine
• if you have been diagnosed with problems absorbing food
• if you are not overweight

Ask a doctor before use if you have ever had

• gallbladder problems
• kidney stones
• pancreatitis

Ask a doctor or pharmacist before use if you are

• taking warfarin (blood thinning medicine), or taking medicine for diabetes or thyroid disease. Your medication dose may need to be adjusted.
• taking other weight loss products

When using this product

• take a multivitamin once a day, at bedtime. orlistat can reduce the absorption of some vitamins.
• follow a well-balanced, reduced-calorie, low-fat diet. Try starting this diet before taking orlistat.
• orlistat works by preventing the absorption of some of the fat you eat. The fat passes out of your body, so you may have bowel changes. You may get:
• gas with oily spotting
• loose stools
• more frequent stools that may be hard to control
• eating a low-fat diet lowers the chances of having these bowel changes
• for every 5 pounds you lose from diet alone, orlistat can help you lose 2-3 pounds more. In studies, most people lost 5-10 pounds over 6 months.

Stop use and ask a doctor if

severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition.

If pregnant or breast-feeding, do not use

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

• store at 20 - 25oC (68 - 77oF)
• protect drug from excessive light, humidity ad temperatures over 30oC (86oF)

AlliTM

Orlistat 60 mg Capsules

Weight Loss Aid

FDA approved

non-prescription

weight loss aid

Helps you lose more weight than dieting alone

150 CAPSULES

For more information, visit www.MyAlli.com

STARTER PACK

SEE TOP OF PACKAGE FOR LISTING OF CONTENTS

The Starter Pack includes:

• Read Me First brochure
• Convenient Carrying Case
• Up to 50 day supply (150 capsules)

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.

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.

Get emergency medical help if you have signs of an allergic reaction to alli: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using alli and call your doctor at once if you have:

• severe stomach pain;

• severe pain in your lower back;

• blood in your urine, painful or difficult urination;

• kidney problems - little or no urinating; swelling in your feet or ankles; feeling tired or short of breath; or

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common alli side effects caused by its fat-blocking action. These are signs that the medicine is working properly. These side effects are usually temporary and may lessen as you continue using alli:

• oily or fatty stools;

• oily spotting in your undergarments;

• orange or brown colored oil in your stool;

• gas and oily discharge;

• loose stools, or an urgent need to go to the bathroom, inability to control bowel movements;

• an increased number of bowel movements; or

• stomach pain, nausea, rectal pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Applies to orlistat: oral capsule

General

In general, the adverse effects of orlistat (the active ingredient contained in Alli) are mild and transient. Because the drug is not systemically absorbed, most adverse effects are limited to the gastrointestinal tract and are primarily extensions of the pharmacologic activity of the drug.[Ref]

Gastrointestinal

During clinical trials, approximately half of all incidents of GI adverse events associated with orlistat (the active ingredient contained in Alli) treatment lasted less than one week, and a majority lasted for no more than four weeks. However, these side effects may occur in some persons over a period of 6 months or longer.

A 42-year-old female experienced constipation, polyuria, polydipsia, and increased lower-leg edema after 2 weeks of treatment with orlistat 120 mg 3 times daily. After the drug was discontinued for 4 days, the symptoms resolved. On reinstitution of the orlistat therapy, the symptoms reappeared within 2 days. Thereafter, the drug was permanently discontinued.[Ref]

Gastrointestinal (GI) side effects including oily spotting, flatus with discharge, fecal urgency, fatty or oily stool, oily evacuation, increased defecation, and fecal incontinence have been reported in greater than or equal to 5% of patients. Cholelithiasis has been reported in 2.9% of patients versus 1.8% in placebo. Other GI side effects possibly related to orlistat treatment have included abdominal pain and discomfort, nausea, infectious diarrhea, rectal pain and discomfort, tooth disorder, gingival disorder, and vomiting. At least one case of constipation has been reported. Pancreatitis has also been reported during postmarketing experience.[Ref]

Hypersensitivity

Hypersensitivity side effects have rarely included pruritus, rash, urticaria, angioedema, bronchospasm, and anaphylaxis. At least one case of cutaneous leukocytoclastic vasculitis has also been reported.[Ref]

A 34-year-old male with a history of obesity experienced cutaneous leukocytoclastic vasculitis coincident with orlistat therapy. He decided to take orlistat (120 mg before meals) as medical therapy for obesity. Seventy-two hours after the onset of this treatment, he experienced myalgias and arthralgias. He also observed the presence of maculopapular lesions in rapidly increasing numbers in his lower extremities. A skin biopsy revealed leukocytoclastic vasculitis affecting capillaries and venules. Orlistat was discontinued and bed rest and nonsteroidal anti-inflammatory drugs were prescribed. Following initiation of this procedure, a rapid improvement of the cutaneous lesions was attained.[Ref]

Respiratory

Respiratory side effects have included influenza, upper respiratory infection, lower respiratory infection, and ear, nose and throat symptoms.[Ref]

Musculoskeletal

Musculoskeletal side effects have included back pain, pain in the lower extremities, arthritis, myalgia, joint disorder, and tendonitis.[Ref]

Nervous system

Nervous system side effects have included headache and dizziness. Postmarketing side effects have included reports of convulsions in patients treated concomitantly with orlistat (the active ingredient contained in Alli) and antiepileptic drugs.[Ref]

Dermatologic

Dermatologic side effects have included rash and dry skin. Rare cases of bullous eruptions have been reported during postmarketing experience.[Ref]

Genitourinary

Genitourinary side effects have included menstrual irregularities and vaginitis. Urinary tract infection has also been reported.[Ref]

Psychiatric

Psychiatric side effects have included psychiatric anxiety and depression.[Ref]

Cardiovascular

Cardiovascular side effects have included pedal edema. At least one case of hypertension has also been reported.[Ref]

A 40-year-old previously healthy female experienced hypertension coincident with orlistat therapy. She took sporadic doses for some months and then increased the dosage to 120 mg three times a day. She experienced dizziness, peripheral edema, and pulsating headache and discontinued treatment. On medical examination, her blood pressure was 190/100 mm Hg on three different measurements. She was advised to discontinue orlistat, and a few days later her blood pressure had decreased to 160/90 mm Hg and the edema had regressed.[Ref]

Hematologic

Hematologic side effects have included decreased prothrombin, increased INR, and unbalanced anticoagulant treatment with changes of hemostatic parameters in patients treated concomitantly with orlistat (the active ingredient contained in Alli) and anticoagulants.[Ref]

Metabolic

Metabolic side effects have included hypoglycemia in clinical trials of obese diabetic patients. At least one case of diabetic ketoacidosis has also been reported, in addition to a case of polyuria and polydipsia.[Ref]

An 18-year-old female with type 1 diabetes for the past 3 years experienced diabetic ketoacidosis coincident with orlistat therapy. She presented to the hospital after she began taking, on her own, orlistat 120 mg three times per day in addition to a low-calorie diet. Laboratory data showed severe ketosis and positive urinary ketones. Orlistat was discontinued, and she was started on intravenous hydration and insulin. She showed significant improvement over a period of 5 days.

A 42-year-old female experienced constipation, polyuria, polydipsia, and increased lower-leg edema after 2 weeks of treatment with orlistat 120 mg 3 times daily. After the drug was discontinued for 4 days, the symptoms resolved. On reinstitution of the orlistat therapy, the symptoms reappeared within 2 days. Thereafter, the drug was permanently discontinued.[Ref]

Hepatic

Hepatic side effects have included rare reports of an increase in transaminases and in alkaline phosphatase, and exceptional cases of hepatitis. No causal relationship or physiopathological mechanism between hepatitis and orlistat (the active ingredient contained in Alli) therapy has been established. At least one case of severe hepatic injury has also been reported. Hepatic side effects submitted post-marketing to the FDA's Adverse Event Reporting System have included jaundice, weakness, and abdominal pain. The FDA has not established an association between liver injury and orlistat at this time.[Ref]

A 15-year-old female without a remarkable medical history experienced severe hepatic injury coincident with orlistat therapy. She had taken orlistat 120 mg three times daily for 7 days for obesity. One week later, she was admitted to an emergency hospital with abdominal pain, malaise, nausea, and diarrhea. Her serum aspartate aminotransferase and alanine aminotransferase levels were surprisingly high at 8269 intl units/L and 9976 intl units/L, respectively. She was given vitamin K intravenously for 5 days, and liver function tests results normalized within 1 month.[Ref]

Renal

Renal side effects including at least one case of acute oxalate nephropathy have been reported.[Ref]

A 57-year-old female with underlying chronic kidney disease experienced acute kidney injury secondary to acute oxalate nephropathy coincident with orlistat therapy. Acute kidney injury was associated temporally with an increased dosage of orlistat therapy and the development of increased fat malabsorption. Kidney biopsy indicated deposition of calcium oxalate crystals within tubular lumens, consistent with acute oxalate crystals within tubules. A steady improvement in renal function was subsequently observed. Results of a repeated 24-hour urine oxalate collection performed 3 weeks later when kidney function had improved were within normal parameters.[Ref]

Other

Other side effects have included fatigue, otitis, and sleep disorders.[Ref]

Some side effects of Alli may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Orlistat has been assigned to pregnancy category X by the FDA. High-dose animal studies have failed to reveal evidence of embryotoxicity or teratogenicity. There are no controlled data in human pregnancy. Since weight loss offers no potential benefit to a pregnant woman and may result in fetal harm, orlistat is contraindicated during pregnancy. If orlistat is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus.