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Xenical is an oral weight loss medication used to help obese people lose weight and keep this weight off.

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INDICATIONS

Xenical is used for managing obesity in adults and adolescents 12 years old and older. It is also used to reduce the risk of weight regain after previous weight loss. Xenical is a gastrointestinal lipase inhibitor. It works by inhibiting the digestion of fats from the diet and should be used with a reduced-calorie diet.

INSTRUCTIONS

Use Xenical as directed by your doctor.

  • Take Xenical by mouth with or up to 1 hour after each main meal that contains fat (up to 3 per day).
  • If a meal is missed or contains no fat, do not take a dose of Xenical.
  • You can take Xenical in conjunction with a mildly reduced-calorie diet up to 3 times a day. Each time you take Xenical, your meal should contain no more than about 30% of calories from fat.
  • You should take a multivitamin supplement containing vitamins A, D, E, and K to ensure good nutrition. The supplement should be taken at least 2 hours before or after you take Xenical, such as at bedtime.
  • If you also take a thyroid hormone (eg, levothyroxine), do not take it within 4 hours before or after Xenical. Check with your doctor if you have questions.
  • If you also take cyclosporine, do not take it within 2 hours before or after Xenical. Check with your doctor if you have questions.
  • If you miss a dose of Xenical, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

DOSAGE

The recommended dose is one 120 mg capsule by mouth with liquid at each main meal that contains fat. Doses greater than 120 mg three times a day have not been shown to provide an additional weight loss benefit.

You should try to follow a healthy eating plan such as the one developed by the American Heart Association. Following this eating plan will help you lose weight while decreasing some of the possible gastrointestinal effects you may experience while taking Xenical.

If your daily calorie level is:

The recommended daily grams of fat (in a 30% fat diet) are:

1500

50

1600

53

1800

60

2000

67

Ask your health care provider any questions you may have about how to use Xenical.

Warnings/Precautions

Do not use Xenical if:

  • ·you are allergic to any ingredient in Xenical;
  • ·you are not overweight;
  • ·you have problems absorbing food or bile flow problems (e.g., cholestasis);
  • ·you have received an organ transplant;
  • ·you take cyclosporine.

Contact your doctor or health care provider right away if any of these apply to you.

Important :

  • ·Do not take more than the recommended dose without checking with your doctor. Taking more than the recommended dose may not help you lose more weight. It may increase your risk of side effects.
  • ·Proper diet and exercise are important in order to lose weight and keep it off. Follow the diet and exercise program given to you by your health care provider.
  • ·Xenical may cause changes in your bowel or stool (e.g., gas with oily spotting, loose stools, more frequent stools). Eating a low-fat diet may help lessen these side effects.
  • ·Tell your doctor or dentist that you take Xenical before you receive any medical or dental care, emergency care, or surgery.
  • ·Diabetes patients – Xenical may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • ·Xenical should not be used in children younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • ·Pregnancy and breast-feeding: Do not take Xenical if you are pregnant. If you become pregnant, contact your doctor. It is not known if Xenical is found in breast milk. Do not breast-feed while taking Xenical.

Possible Side Effects

Check with your doctor if any of these most common side effects persist or become bothersome:

  • ·diarrhea; gas with discharge; frequent or loose stools; oily spotting; trouble controlling bowel movements.

Seek medical attention right away if any of these severe side effects occur:

  • ·severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent stomach pain.

More Information

Xenical is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

STORAGE

Store Xenical at room temperature beetwen 68 and 77 degrees F (20-25 degrees C) in a tight, light-resistant container, away from heat, moisture and light. Keep Xenical out of the reach of children.

Active Ingredient: Orlistat.

Other Ingredients: Microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, and talc.

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