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XENICAL.com -- Important Safety Information


Indication

XENICAL is a prescription medicine used with a low calorie diet to increase weight loss in people with obesity. XENICAL may help obese people lose weight and keep the weight off.

It is not known if XENICAL is safe and effective in children under 12 years old.


Important Safety Information

Do not take XENICAL if you:
  • are pregnant. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese.
  • have food absorption problems (chronic malabsorption syndrome)
  • have gallbladder problems (cholestasis)
  • are allergic to orlistat or any of the ingredients in XENICAL
Before you take XENICAL, tell your doctor if you:
  • have liver problems
  • have kidney problems
  • have problems with your thyroid
  • have eating problems such as anorexia or bulimia
  • have diabetes
  • are breastfeeding or plan to breastfeed. It is not known if XENICAL passes into your breast milk. Talk to your doctor before you breastfeed and take XENICAL.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you are taking:
  • cyclosporine (Gengraf, Neoral, Sandimmune, Restasis, Sangcya)
  • beta-carotene or vitamin E supplements
  • levothyroxine (Levo-T, Levolet, Levothyroid, Levothyroxine Sodium, Levoxyl, Novothyrox, Synthroid, Tirosint, Unithroid)
  • warfarin (Athrombin, Athrombin-K, Coumadin, Jantoven, Panwarfin, Warfarin Sodium)

XENICAL may cause serious side effects, including:
  • Lowered absorption of certain vitamins in your body. Take a multivitamin containing vitamins A, D, E, K, and beta-carotene one time each day. Take a multivitamin at least 2 hours before or after you take XENICAL, such as at bedtime.
  • Severe liver problems. Stop taking XENICAL and call your doctor right away if you have the following symptoms of liver problems:
    • loss of appetite
    • itchy skin
    • yellowing of your skin or the white part of your eyes
    • amber-colored urine
    • light-colored bowel movements (stools)
    • pain in the upper right portion of your stomach
  • Kidney problems. Your doctor may do certain tests to check your kidney function during treatment with XENICAL. Call your doctor right away if you have the following symptoms of kidney problems:
    • swelling, especially of the legs and feet
    • little or no urine output
    • frequent or painful urination
    • blood in the urine
    • loss of appetite, nausea and vomiting
    • severe pain in the back, belly or groin
  • Gallbladder problems (gallstones). Call your doctor right away if you have the following symptoms of gallstones:
    • pain in the upper right portion of your stomach
    • nausea
    • vomiting

The most common side effects of XENICAL include:
  • oily* rectal discharge
  • passing gas with oily discharge*
  • urgent need to have a bowel movement
  • oily* or fatty stools
  • increased number of bowel movements
  • being unable to control your bowel movements
*Oily discharge may be clear or have an orange or brown color.


How should I take XENICAL?
  • Take XENICAL exactly as your doctor tells you to take it.
  • Your doctor will tell you how much XENICAL to take and when to take it.
  • Take XENICAL with your meals or up to one hour after your meal. If you miss a meal or have a meal without fat, you can skip your dose of XENICAL. If you take a cyclosporine medicine, take XENICAL and cyclosporine at least 3 hours apart. See "What should I tell my doctor before taking XENICAL?" for a complete list of cyclosporine medicines.
  • If you take a multivitamin, take it at least 2 hours before or after you take XENICAL. Bedtime is a good time to take your multivitamin.
  • If you take a levothyroxine medicine, take XENICAL and levothyroxine at least 4 hours apart. See "What should I tell my doctor before taking XENICAL?" for a complete list of levothyroxine medicines.
  • If you take a cyclosporine medicine, take it at least 3 hours after you take XENICAL. See "What should I tell my doctor before taking XENICAL?"
Take XENICAL with a nutritionally balanced, low calorie diet that has no more than about 30% of calories from fat. Taking XENICAL with any meal high in fat (more than 30% fat) may make the common side effects worse.

If you take too much XENICAL call your doctor or go to the nearest hospital emergency room right away.

These are not all the possible side effects of XENICAL. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Click here for Important Patient Information.