Orlistat (Tetrahydrolipstatin) capsule

What is this medicine?

Orlistat is used to help obese people lose weight and keep the weight off while eating a reduced-calorie diet. Orlistat decreases the amount of fat that is absorbed from your diet.

What should my health professional know before I take this medicine?

They need to know if you have any of these conditions:

• an eating disorder, such as anorexia or bulimia
• problems absorbing food (chronic malabsorption)
• gallbladder problems or gallstones
• diabetes
• if you are taking any other weight-loss medications
• an unusual or allergic reaction to orlistat, other medicines, foods, dyes, supplements or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Orlistat is taken by mouth and swallowed with a drink of liquid. You can take orlistat with each main meal that contains about 30% of the calories from fat. Or you can take the capsule one hour after the meal. Do not take your medicine more often than directed. If you occasionally miss a meal or have a meal without fat, you can omit that dose of orlistat. Doses greater than 120 mg three times per day have not been shown to increase weight loss.

You should use orlistat with a reduced-calorie diet that contains no more than about 30% of the calories from fat. Divide your daily intake of fat, carbohydrates, and protein evenly over your 3 main meals. You should try to follow a healthy eating plan as prescribed by your doctor such as the one developed by the American Heart Association. Following this eating plan can help reduce the possible GI side effects from orlistat.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it within one hour following the meal that contains fat. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Whatmay interact with this medicine?

• Dietary supplements, such as beta-carotene and vitamins A, D, E, and K
• warfarin
• cyclosporine
• pravastatin
• drugs used to treat diabetes

Tell your prescriber or other health care professional about all other medicines you are taking including non-prescription medicines, nutritional supplements, or herbal products. Also, tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke or if you use illegal drugs. These may affect the way your medicine works. Check before stopping or starting any of your medications.

What should I watch for while taking this medicine?

Since orlistat can cause decreased absorption of some fat-soluble vitamins, you may need to take a daily multivitamin that contains normal amounts of vitamins D, E, K and beta-carotene. Take the multivitamin once per day at least 2 hours after your dose of orlistat unless otherwise directed by your physician or other healthcare professional.

Watch for any unusual changes in your body's normal function. You need to watch the amount of fat in your diet. Too much dietary fat can increase the side effects from orlistat. Also, watch for any changes in your eyesight, skin or hair that may be caused by a vitamin deficiency.

What side effects may I notice from this medicine?

The side effects seen with orlistat are related to the reduced absorption of fat from your diet. Gastrointestinal (GI) side effects may last for less than one week, but have occurred for up to 6 months or longer. Maintaining an appropriate diet can help decrease side effects. The use of orlistat for greater than 2 years has not been studied.

Side effects that you should report to your prescriber or health care professional as soon as possible:

• arthritis or joint pain/tenderness
• back pain
• rash, itching, or shortness of breath
• severe stomach pain
• yellow color appearing in your skin or the whites of your eyes
• weakness or fainting

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

• stomach discomfort
• increased number of bowel movements
• loss of control of bowel movements
• urgent need to go to the bathroom
• gas with release of stool
• oily/fatty stools
• oily discharge
• clear, orange or brown colored bowel movements

This list may not describe all possible side effects.

Where can I keep my medicine?

Keep out of the reach of children in a container that small children cannot open.

Storage at 25° C (77° F) is preferred. You may store at 15° to 30°C (59° to 86° F). Protect from moisture. Keep container tightly closed.Throw away any unused medicine after the expiration date.