Xenical® 120mg, Blister of 84 Caps
INFORMATION FOR THE PATIENT
What the medication is used for:
XENICAL® is used along with a mildly reduced-calorie diet to assist in weight loss and to maintain the weight loss in obese patients and overweight patients who have health risk factors such as type 2 diabetes, high blood pressure, and blood lipid problems. The weight loss will contribute to lowering the blood pressure and cholesterol and blood sugar levels. Even a modest weight loss of 5-10% can lower your risk of developing health problems. The weight loss achieved with XENICAL®, along with a mildly reduced calorie diet, may also help reduce the risk of developing type 2 diabetes if you have impaired 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
What it does:
XENICAL® works by blocking some of the fat that you eat from being absorbed by your body.
Enzymes in your digestive system, called lipases, help digest (or break down) fat. XENICAL® inhibits pancreatic lipase, an enzyme that breaks down triglycerides in the intestine. Without this enzyme, triglycerides from the diet cannot be absorbed and are excreted undigested. XENICAL® helps block about one-third of the fat in the foods you eat from being absorbed by your body. By consuming fewer calories, your body will automatically tap into its fat stores and use them for the energy it needs.
When it should not be used:
XENICAL® should not be used in patients with chronic malabsorption syndrome, cholestasis, and in patients with known hypersensitivity with orlistat or to any component of XENICAL®. Chronic malabsorption syndrome is when the body has trouble absorbing nutrients from the intestine into the bloodstream. Cholestasis is caused by an obstruction in the liver where bile, a fluid made in the liver, is not able to be eliminated from the body through the intestine normally. XENICAL® is not intended to be used in children under 12 years of age, as this medicine has not been studied in this age group
What the medicinal ingredient is:
What the nonmedicinal ingredients are:
Microcrystalline cellulose, povidone, sodium starch glycolate, sodium lauryl sulphate, talc.
The capsule shell contains: gelatin, indigo carmine, titanium dioxide, edible printing ink
What dosage forms it comes in:
XENICAL® is a turquoise capsule with “XENICAL 120” printed in black ink
ABOUT THE DISEASE
Obesity is a condition characterized by abnormal or excessive fat accumulation. Obesity isn’t just a cosmetic concern. It is a medical problem that increases your risk of other diseases and health problems, such as heart disease, diabetes, high blood pressure and certain cancers.
There are many reasons why some people have difficulty avoiding obesity. Usually, obesity results from a combination of inherited factors, combined with the environment and personal diet and exercise choices.
The good news is that even modest weight loss can improve or prevent the health problems associated with obesity. Dietary changes increased physical activity and behavior changes can help you lose weight. Prescription medications and weight-loss procedures are additional options for treating obesity
FREQUENTLY ASKED QUESTIONS
Orlistat belongs to a class of medications known as anti-obesity agents, specifically gastrointestinal lipase inhibitors. When combined with a mildly reduced-calorie diet that contains no more than 30% of calories from fat, orlistat is used to help obese people lose weight and maintain weight loss.
Lipase is an enzyme that is needed to break down dietary fats into fatty acids, which is the form of fat that gets absorbed. Orlistat blocks the action of lipase and therefore prevents dietary fat from being absorbed. At the recommended dose, orlistat inhibits dietary fat absorption by approximately 30%.
This medication should only be used by people who have a body mass index (BMI) of 30 kg/m² or higher, or by people with a BMI of 27 kg/m² or higher with other health risk factors such as high blood pressure, type 2 diabetes, high cholesterol, or large waist measurement. BMI is not a direct measure of fat and these guidelines do not apply to athletes and pregnant women.
Orlistat can also be used in combination with diabetes medications to improve blood glucose control in overweight or obese people with type 2 diabetes whose blood glucose levels are inadequately controlled with diet, exercise, and diabetes medications (e.g., glyburide, insulin, metformin).
XENICAL® is supplied in blister packages in cartons of 84 capsules
The recommended adult dose is 120 mg three times daily with each main meal (breakfast, lunch, and dinner) or up to 1 hour after the meal. If you occasionally miss a meal or the meal does not contain fat, do not take the dose of orlistat. Swallow the capsule whole with some water.
Orlistat should be taken with a mildly reduced-calorie diet that contains no more than 30% of calories from fat, as recommended by your doctor, dietitian, or other health care professional.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, it can be taken up to 1 hour after a meal and still be effective. However, if it is greater than an hour when you remember, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Do not take this medication if you:
- are allergic to orlistat or any ingredients of the medication
- have cholestasis (a condition where bile excretion in the liver is stopped)
- have chronic malabsorption syndrome (a condition where you do not absorb nutrients from food properly)
The most common possible side effects from XENICAL® are directly related to the way XENICAL® works. By blocking the absorption of some dietary fat, it is likely that you will experience some change in bowel habits. These effects are generally mild and transient (occur for a short period of time). They can increase if you eat high fat foods. In clinical studies, only 3% of people experienced one of these effects more than twice:
- 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.
Due to the presence of undigested fat, the oil in your bowel movement may be clear, orange or brown in colour. These bowel changes are a natural effect of blocking the fat from being absorbed and indicate that XENICAL® is working.
Kidney problems, including kidney failure, have been reported with the use of XENICAL®. Your doctor may do certain tests to check your kidney function while you are taking XENICAL®
If you are concerned about these or any other unexpected effects while on XENICAL®, talk with your doctor or pharmacist.
This is not a complete list of side effects. For any unexpected effects while taking XENICAL®, contact your doctor or pharmacist.
Drugs that may interact with XENICAL® include cyclosporine, amiodarone, and levothyroxine.
If you experience severe diarrhea, birth control pills might not work as well and you might need to use an additional birth control method
Provided you remember within one hour of your last meal, take your XENICAL® capsule and then go back to taking it as you would normally. If it is more than one hour after your last main meal, skip the dose you missed and take your next dose when you are meant to.
If you are not sure whether to skip the dose, talk to your pharmacist or doctor.
Do not double a dose to make up for the one you have missed.
If you have missed several doses just go back to taking XENICAL® as you would normally.
The amount of weight you lose depends on how well you stick to a reduced-calorie diet with no more than 30% of calories from fat and an appropriate physical activity level, as well as on your compliance with the prescribed medication regimen.
Typically, people begin losing weight within 2 weeks of starting XENICAL®, and may continue to lose weight for 6 to 12 months, at which point weight loss usually begins to level off – even if you’re still taking XENICAL®. This doesn’t mean that XENICAL® is not working. People who continue to take XENICAL® are better able to maintain their weight loss
Store XENICAL® in its original labeled 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
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