Xenical

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 Xenical (Orlistat). Swallow the capsule whole with some water.

Xenical (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 Xenical (Orlistat) 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.

Store Xenical (Orlistat) at room temperature in the original package, protect it from moisture, and keep it away from heat and out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause abdominal discomfort; it may affect menstruation (irregular or absence of menses); it may cause fatty stools and oily discharge from the rectum; it may create the urgent need to have a bowel movement. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Each turquoise capsule, with "Roche Xenical 120" printed in black ink, contains 120 mg of Xenical (Orlistat). Nonmedicinal ingredients: gelatin, indigo carmine, microcrystalline cellulose, povidone K30, sodium lauryl sulfate, sodium starch glycolate, talc, and titanium dioxide.

Do not take Xenical (Orlistat) if you:

• are allergic to Xenical (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)

There may be an interaction between Xenical (Orlistat) and any of the following:

• Amiodarone
• beta-carotene
• birth control pills
• Calcitriol
• certain diabetes medications (e.g., glyburide, Gliclazide, insulin, metformin)
• Cyclosporine
• fat-soluble vitamin supplements (e.g., vitamin A, vitamin D, vitamin E, and vitamin K)
• Levothyroxine
• oral anticoagulants (e.g., Warfarin)
• Propafenone
• seizure medications (e.g., Carbamazepine, Phenytoin, Phenobarbital)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Xenical (Orlistat). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription) and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin taking a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Xenical (Orlistat).

Diabetes: If you have type 2 diabetes and are taking Xenical (Orlistat) in combination with other diabetes medications, you may be more at risk of experiencing Hypoglycemia (low blood sugar). If you experience hypoglycemia symptoms such as sweating, dizziness, shakiness, hunger, or confusion, contact your doctor. Your doctor may need to adjust the dose of your medication(s). You should continue to monitor your blood sugar levels regularly.

Fat intake: It is very important to follow recommended dietary guidelines while taking Xenical (Orlistat). The risk of side effects associated with the stomach (such as gas with discharge or oily spotting of underclothes) increases when Xenical (Orlistat) is taken with a high-fat diet. Your daily intake of fat should be distributed over three main meals and should not be more than 30% of the total calories. Discuss with your doctor or dietitian if you have any concerns or questions regarding how to manage your diet.

Gastrointestinal problems: If you have bowel or rectal problems, discuss with your doctor how Xenical (Orlistat) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xenical (Orlistat), and whether any special monitoring is needed. Bleeding from the rectum has been reported with the use of Xenical (Orlistat). If this occurs, contact your doctor as soon as possible.

Kidney stones: If you have a history of kidney stones, discuss with your doctor how Xenical (Orlistat) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xenical (Orlistat), and whether any special monitoring is needed.

Liver: There have been rare reports of severe liver injury in people taking Xenical (Orlistat). If you experience any symptoms such as loss of appetite, yellow skin or eyes, abdominal pain, dark urine, light-coloured stools, or pain in the upper right part of the abdomen, contact your doctor immediately.

Seizures: Xenical (Orlistat) may interact with seizure medications by decreasing the amount of seizure medication that your body absorbs. This can result in increased seizures. If you have a history of seizures, discuss with your doctor how Xenical (Orlistat) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xenical (Orlistat), and whether any special monitoring is needed.

Thyroid: Xenical (Orlistat) may affect how well your thyroid gland works, possibly by reducing the amount of iodine available from your diet for your body to produce thyroid hormone. If you have Hypothyroidism (low thyroid hormone levels), your doctor should closely monitor your condition while you are taking Xenical (Orlistat), as it may affect thyroid levels.

Vitamins: Xenical (Orlistat) may reduce the absorption of beta-carotene and fat-soluble vitamins such as vitamin A, vitamin D, vitamin E, and vitamin K. Talk to your doctor or pharmacist about taking a multivitamin supplement. If you are already on a multivitamin, take it at least 2 hours before or after taking Xenical (Orlistat), or take it at bedtime.

Pregnancy: Xenical (Orlistat) has not been adequately studied in pregnant women. Xenical (Orlistat) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Xenical (Orlistat), contact your doctor immediately.

Breast-feeding: It is not known if Xenical (Orlistat) passes into breast milk. If you are a breast-feeding mother and taking Xenical (Orlistat), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Xenical (Orlistat) have not been established for use in children less than 12 years of age.

This product is more effective if used in conjunction with an appropriate diet and exercise program. This medication is typically used 3 times a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication is more effective if taken with food. Always take it with a meal or a snack. If you skip a meal, skip your mealtime dose of this medication as well. Avoid taking multivitamins within 2 hours (before or after) of this medication.