September 5, 2015
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Xenical

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Xenical




PATIENT INFORMATION

XENICAL®
(zen' i-cal)
(orlistat) Capsules

Read this Patient Information before you start taking XENICAL and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is XENICAL?

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.

Who should not take XENICAL?

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.
  • always have problems absorbing food (chronic malabsorption)
  • have gallbladder problems (cholestasis)
  • are allergic to orlistat or any of the ingredients in XENICAL. See the end of this leaflet for a complete list of ingredients in XENICAL

What should I tell my doctor before taking 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
  • have a seizure disorder (epilepsy)
  • have an abnormal heart rhythm (arrhythmia)
  • 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.
  • are pregnant or plan to become pregnant. Do not take XENICAL if you are pregnant or plan to become pregnant.

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

XENICAL and other medicines may affect each other causing side effects. XENICAL may affect the way other medicines work, and other medicines may affect the way XENICAL works.

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)
  • medicines used to treat seizures
  • amiodarone (Cordarone, Pacerone)
  • Medicines used to treat seizures may not work as well while you take XENICAL. Talk to your doctor right away if your seizures happen more often or get worse while you take XENICAL.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

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.
  • 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. See Table 1.

Table 1

    WEIGHT (lb)
120 130 140 150 160 170 180 190 200 210 220 230 240 250 260 270 280 290 300 310 320
HEIGHT (ft/in) 4'10” 25 27 29 31 34 36 38 40 42 44 46 48 50 52 54 57 59 61 63 65 67
4'11” 24 26 28 30 32 34 36 38 40 43 45 47 49 51 53 55 57 59 61 63 65
5'0” 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57 59 61 63
5'1” 23 25 27 28 30 32 34 36 38 40 42 44 45 47 49 51 53 55 57 59 61
5'2” 22 24 26 27 29 31 33 35 37 38 40 42 44 46 48 49 51 53 55 57 59
5'3” 21 23 25 27 28 30 32 34 36 37 39 41 43 44 46 48 50 51 53 55 57
5'4” 21 22 24 26 28 29 31 33 34 36 38 40 41 43 45 46 48 50 52 53 55
5'5” 20 22 23 25 27 28 30 32 33 35 37 38 40 42 43 45 47 48 50 52 53
5'6” 19 21 23 24 26 27 29 31 32 34 36 37 39 40 42 44 45 47 49 50 52
5'7” 19 20 22 24 25 27 28 30 31 33 35 36 38 39 41 42 44 46 47 49 50
5'8” 18 20 21 23 24 26 27 29 30 32 34 35 37 38 40 41 43 44 46 47 49
5'9” 18 19 21 22 24 25 27 28 30 31 33 34 36 37 38 40 41 43 44 46 47
5'10” 17 19 20 22 23 24 26 27 29 30 32 33 35 36 37 39 40 42 43 45 46
5'11” 17 18 20 21 22 24 25 27 28 29 31 32 34 35 36 38 39 41 42 43 45
6'0” 16 18 19 20 22 23 24 26 27 29 30 31 33 34 35 37 38 39 41 42 43
6'1” 16 17 19 20 21 22 24 25 26 28 29 30 32 33 34 36 37 38 40 41 42
6'2” 15 17 18 19 21 22 23 24 26 27 28 30 31 32 33 35 36 37 39 40 41

This Patient Information has been approved by the U.S. Food and Drug Administration.

Pharmacist reviewed on 8/26/2015

Prescribing Document Revised: October 2013

This monograph has been modified to include the generic and brand name in many instances.

Xenical - User Reviews

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