Xenical: Uses, Side Effects and Dosage

What is XENICAL used for?

XENICAL is used along with a lower calorie diet for:

• Managing obesity, including weight loss and maintaining the lost weight.
• Reducing the risk of regaining weight after losing weight.

XENICAL is also used in combination with diabetes medicines (sulfonylureas, metformin and/or insulin) to improve blood glucose control. It is used in overweight or obese type 2 diabetes patients, who do not respond adequately to diet, exercise and diabetes medicines alone.

The weight loss caused by XENICAL along with a lower calorie diet may contribute to lowering the blood pressure, cholesterol and blood sugar levels. It may also reduce risk of developing type 2 diabetes if you have problems with glucose tolerance.

XENICAL is recommended for:

• patients with a Body Mass Index (BMI*) greater than or equal to 30 kg/m², or

• patients with a BMI* greater than or equal to 27 kg/m² who have health problems, such as type 2 diabetes, high blood pressure, high cholesterol or a large waist measurement.

  * BMI is a simple measurement to estimate how overweight a person is. See your doctor to have your BMI measured.

How does XENICAL work?

XENICAL is a prescription medicine when, combined with a lower calorie diet (average 20% decrease in daily calories, and no more than 30% of calories from fat), can help you lose weight and keep it off.

XENICAL contains the active ingredient Orlistat. It works by attaching to an enzyme in your digestive system called lipase, preventing these enzymes from working. This blocks absorption of about one third (30%) of the fat in food you eat. The undigested fat cannot be absorbed by your body and passes out of the body in the stool. When you absorb less fat, you take in fewer calories, which may lead to weight loss.

XENICAL does not suppress or change your appetite. Less than 1% of XENICAL is absorbed and the rest leaves the body in the stool.

Type 2 diabetes

XENICAL taken in combination with diabetes medications such as insulin, metformin and/or a sulfonylurea (like glyburide) may help you manage your type 2 diabetes by lowering your blood sugar.

What are the ingredients in XENICAL?

Medicinal ingredients: orlistat

Non-medicinal ingredients: edible printing ink, gelatin, indigo carmine, microcrystalline cellulose, povidone, sodium lauryl sulphate, sodium starch glycolate, talc, titanium dioxide.

XENICAL comes in the following dosage forms:

Capsules, 120 mg

Do not use XENICAL if:

• you have chronic malabsorption syndrome. This is a condition where your body has trouble absorbing nutrients from the intestine into the bloodstream.
• you have cholestasis (a liver disorder).

• you are breastfeeding or planning to breastfeed. It is not known if orlistat passes through breast milk.

• you are pregnant. XENICAL may harm your unborn baby.
• you are allergic (hypersensitive) to orlistat or to any other ingredients in XENICAL (see “What are the ingredients in XENICAL?”).

XENICAL is NOT for use in children under 12 years of age, as this medicine has not been studied in this age group.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take XENICAL. Talk about any health conditions or problems you may have, including if you:

• have ever had a bad reaction to orlistat or any other ingredients in XENICAL.
• are allergic to other medicines, foods or dyes.
• have problems absorbing your food (chronic malabsorption syndrome).
• have bowel or rectal problems.
• have gallbladder problems.
• have kidney problems. Kidney injury has been reported in patients treated with XENICAL.
• are pregnant, plan on becoming pregnant, or are breastfeeding.
• are taking birth control pills to prevent pregnancy. If you experience severe diarrhea, your birth control pills might not work as well. When this happens, you might need to use an additional birth control method.

Other warnings you should know about:

Check-ups and testing

• You will have regular visits with your healthcare professional during your treatment with XENICAL to monitor your health.
• If you have diabetes, you will have tests for fasting glucose, as needed.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with XENICAL:

• cyclosporine, used to lower the risk of organ rejection
• amiodarone, used to treat abnormal heart rhythm
• levothyroxine, used to treat hypothyroidism (underactive thyroid gland)
• anticoagulants, used to prevent blood clots (e.g. warfarin)
• medicines to treat HIV
• acarbose, used to treat type 2 diabetes mellitus
• antidepressants, used to treat depression
• antipsychotics, used to treat psychiatric disorders (e.g. lithium)
• benzodiazepine, used to treat anxiety and sleep disorders
• anticonvulsants, used to treat or prevent seizures
• birth control pills, used to prevent pregnancy

How to take XENICAL:

• Take XENICAL exactly as your healthcare professional tells you. Check with your healthcare professional if you are not sure.

• Take during or after a meal. The capsule should be taken within 1 hour of eating a meal. For example, if you just finished eating lunch at 12:30 p.m., you should take your lunchtime dose before 1:30 p.m.

• Swallow whole with water.
• If you occasionally miss a main meal or if your meal contains no fat, do NOT take your XENICAL capsule.
• Do NOT take more than the recommended dose prescribed by your healthcare professional. You will not lose more weight or lose it more quickly if you take more XENICAL capsules than your healthcare professional has instructed.

What else should you remember while taking XENICAL?

• XENICAL should be taken with a mildly reduced calorie diet that contains no more than 30% of calories from fat. Follow the recommendations from your healthcare professional.

• General diet recommendations:

  • Eat foods from all food groups (for example, see “Canada’s Food Guide to Healthy Eating”).
  • Divide your day’s calories and fat over 3 meals. Choose foods that have a lower fat content.
  • Add less fat (butter, margarine or oils) to the foods you prepare.
  • Develop healthy eating habits, like eating more fruits and vegetables.
• XENICAL can reduce the absorption of certain nutrients, like vitamins and beta-carotene. Your healthcare professional may recommend you take a multivitamin supplement during treatment with XENICAL. Follow their instructions on when to take the multivitamin supplement.
• Gradually increase your physical activity as recommended by your healthcare professional.
• If you have to go to the hospital or if you are given a new prescription medicine, tell your healthcare professional that you are taking XENICAL.

• If you have type 2 diabetes:

  • Your reduced calorie diet should be consistent with the dietary recommendations of the Canadian Diabetes Association Guidelines for the Nutritional Management of Diabetes Mellitus in the New Millennium.
  • You should talk with your healthcare professional about diabetes medications you may be taking, as the dose may need to be changed.

Usual dose:

One capsule (120 mg) three times daily, with each main meal (breakfast, lunch and dinner).

Overdose:

Missed Dose:

If you forget to take a dose, take it as soon as you remember. It can be taken up to one hour after a meal. Do NOT take double the dose to make up for a dose you have missed.

What are possible side effects from using XENICAL?

These are not all the possible side effects you may have when taking XENICAL. If you experience any side effects not listed here, tell your healthcare professional.

• Changes to bowel movement, including:

  • oily spotting, gas with discharge, urgent need to have a bowel movement, fatty/oily stools, oily discharge, increased number of bowel movements, inability to control bowel movements.
• Nausea, vomiting
• Fatigue
• Back pain
• Muscle and joint pain
• Headache
• Upper respiratory infection, like a cold

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

• Store XENICAL in its original labelled container at room temperature (between 15-25°C). Keep the blister package in the XENICAL outer carton, in order to protect it from light and moisture.
• Store away from heat.
• Do not use this medicine after the expiry date on the package.
• Keep out of reach and sight of children.

If you want more information about XENICAL:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) or by calling the importer (Xediton Pharmaceuticals Inc) at 1-888-XEDITON (933-4866).

Last Revised: JUL 05, 2023

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XENICAL® is a registered trademark of CHEPLAPHARM Arzneimittel GmbH.

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CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24, 17489 Greifswald, Germany