What ELE-ALIS is and what it is used for

ELE-ALIS is a reversible inhibitor of gastrointestinal lipases indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. ELE-ALIS is also indicated to reduce the risk for weight regain after prior weight loss.

ELE-ALIS is indicated for obese patients with an initial body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (eg,hypertension, diabetes, dyslipidemia). The BMI is calculated by dividing weight in kilograms by height in meters squared.

What is the mechanism of ELE-ALIS

Orlistat is a reversible inhibitor of gastrointestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue site of gastric and pancreatic lipases. The inactivated enzymes are thus unavailable to hydrolyze dietary fat in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides are not absorbed, the resulting caloric deficit may have a positive effect on weight control.

How to take ELE-ALIS

For Oral administration

The recommended dose is one 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal).The patient should be on a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat. The daily intake of fat, carbohydrate, and protein should be distributed over three main meals. If a meal is occasionally missed or contains no fat, the dose of ELE-ALIS can be omitted.

Because ELE-ALIS has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene, patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition. The vitamin supplement should be taken at least 2 hours before or after the administration of Thontal, such as at bedtime.

Doses above 120 mg three times a day have not been shown to provide additional benefit.

Based on fecal fat measurements, the effect of ELE-ALIS is seen as soon as 24 to 48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours.

Possible side effects

ELE-ALIS 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 Thontal, such as at bedtime.
• Severe liver problems. Stop taking Thontal 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 eyesamber-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 ELE-ALIS. 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 ELE-ALIS 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.

Warnings and Special Precautions

Contraindications:

Thontal is contraindicated in:

• Pregnancy
• Patients with chronic malabsorption syndrome
• Patients with cholestasis
• Patients with known hypersensitivity to any component of this product

Warnings and Special Precautions:

• Thontal can decrease cyclosporine exposure. For patients receiving both ELE-ALIS and cyclosporine therapy, administer cyclosporine 3 hours after ELE-ALIS.
• Take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition.
• Rare cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported.
• Patients may develop increased levels of urinary oxalate following treatment with ELE-ALIS. Monitor renal function in patients at risk for renal insufficiency.
• Substantial weight loss can increase the risk of cholelithiasis.
• Exclude organic causes of obesity (eg, hypothyroidism) before prescribing ELE-ALIS. For patients receiving both ELE-ALIS and levothyroxine therapy, administer levothyroxine and ELE-ALISat least 4 hours apart. Patients treated concomitantly with Thontal and levothyroxine should be monitored for changes in thyroid function.
• Gastrointestinal events may increase when ELE-ALIS is taken with a diet high in fat (>30% total daily calories from fat).

How to store ELE-ALIS

Store at 15°C to 30°C. Keep the product in the outer carton in order to protect from light.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date that is stated on the outer carton and the label after “EXP”. The expiry date refers to the last day of that month.

Contents of the pack and other information

What ELE-ALIS contains

The active substance and there contents were listed as following:

Brand Name Contents of active substance

Thontal : Each capsule contains orlistat 120mg.

There are other ingredients of excipients as microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, gelatin

and titanium dioxide.

What ELE-ALIS looks like and contents of the pack

ELE-ALIS is hard capsule.

Pack size:

84 capsules per bottle per carton

Shelf life

36 months.