Reesize

REESIZE 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 the risk of developing health problems.

The weight loss achieved with REESIZE, along with a mildly reduced calorie diet, may also help reduce the risk of developing type 2 diabetes if the patient has impaired glucose tolerance.

• Patients with a Body Mass Index (BMI*) greater than or equal to 29 kg/m2, or
• Patients with a BMI* greater than or equal to 25 kg/m2 who have health problems, such as, type 2 diabetes, high blood pressure, high cholesterol or a large waist measurement.

• REESIZE is a prescription medicine when, combined with a mildly reduced calorie diet (average 20% decrease in daily calories, and no more than 30% of calories from fat), can help patients lose weight and maintain it.
• REESIZE is a fat blocker. Fats from foods need to be broken down into triglycerides and fatty acids for being absorbed into the body. To break down fat lipases are used in the GI tract. REESIZE, when taken with meals, prevents GI lipases, leading to prevention of absorption of about one third (30%) of the fat in food. Unabsorbed fat is passed in stool. Less fat leads to less calories assimilated, leading to weight loss.
• REESIZE can be combined with insulin, metformin and/or a sulfonylurea may help more efficient management of overweight type 2 diabetes by helping lowering hyperglycemia.
• REESIZE does not suppress or change appetite. It is not centrally acting like other medicines used for weight loss (Many of which are banned). Less than 1% of REESIZE is absorbed, and the rest is excreted in the stool.

REESIZE should not be used in patients with chronic malabsorption syndrome, cholestasis and in patients with known hypersensitivity with Orlistat or to any component of REESIZE (See “What the important nonmedicinal ingredients”). REESIZE is not intended to be used in children under 12 years of age, as this medicine has not been studied in this age group.

Each capsule contains 120 mg and 60 mg respectively of the active ingredient, Orlistat.

The capsules contain non-medicinal or inactive ingredients. These are microcrystalline cellulose, povidone, sodium starch glycolate, sodium lauryl sulphate, talc. The capsule shell contains gelatin, indigo carmine, and titanium dioxide.

REESIZE is a capsule, available in 60 and 120 mg strengths.

• Your patient has ever had a bad reaction to Orlistat (REESIZE) or any of the inactive ingredients of REESIZE
• Your patient is allergic to other medicines, foods and dyes
• Your patient is taking cyclosporine
• Your patient is on diabetes medicines, such as, insulin, metformin and/or a sulfonylurea
• Your patient is taking any other medicines including those not prescribed by other doctors or healthcare professionals
• Your patient has chronic malabsorption syndrome
• Your patient has bowel or rectal problems
• Your patient has gallbladder problems
• Your patient is pregnant, has plan on becoming pregnant, or is breastfeeding.

This information will help you decide whether you should prescribe REESIZE, and what extra care may need to be taken while your patients is on REESIZE.

REESIZE  prescription calls for careful consideration of each case. As you know, other people may not benefit from taking this medicine, even though their problems may seem similar to one of your patients whom you have prescribed. Instruct your patients strictly not to give REESIZE to anyone else.

• One capsule (120 mg) of REESIZE is to be taken during or just following each main meal (breakfast, lunch and dinner). The patient would swallow the capsule whole along with some water. The capsule is to be taken no later than 1 hour after the meal is eaten.
• Those who have lost weight with 120 mg of REESIZE, you may consider prescribing them 60 mg in a thrice daily dosing to help maintain achieved weight loss.
• Given an example to the patient explaining the timeline, if your patient has just finished eating lunch at 12:30 p.m., he/she must take the lunchtime dose of REESIZE before 1:30 p.m.
• Please recommend that REESIZE should be taken with a mildly reduced calorie diet that contains no more than 30% of calories from fat.
• Advise that REESIZE can reduce the absorption of fat-soluble vitamins and beta-carotene. In clinical studies, most people's vitamin and beta-carotene levels were within the normal range. However, to be on the safe side, it is desirable that you advise your patients to take a daily multivitamin supplement while taking REESIZE, specially if your patients is between the ages of 12 to 16.
• A multivitamin should be taken two hours before or after oral administration of the REESIZE capsule, or at bedtime.
• If your patient occasionally misses a main meal or if the meal contains no fat, the patients should be advised for skipping the REESIZE capsule dosing.
• Since REESIZE is only sold with your prescription, you should strictly direct your patients about that and explain about its intake. They should also be advised not to overdose, against more frequent use, and against a longer duration than your orders.
• You need to explain to your patients that they will not lose more weight or lose it more quickly if they take more REESIZE capsules than you have instructed.

• Your patient needs to be instructed on diet. The reduced calorie diet in such patients should be consistent with the dietary recommendations that you follow in practice.
• You perhaps know your patient's anti-diabetic medications, and with concurrent therapy with REESIZE, some such patients may need dose adjustments of anti-diabetic medications. Assure your patients that taking REESIZE can help your patient to reach a healthier weight, and advise for physical activity since REESIZE works best when your patients take it as directed, eat less fat and become more physically active.

• As REESIZE works by partially blocking dietary fat absorption, the expected weight loss will not occur if the patients replace the fat calories with carbohydrates or protein. Diet must be regulated strictly.
• The patients must eat foods from all food groups to maintain a nutritional balance.
• The patients must be counseled to divide their day's calories and fat over 3 meals.
• Provide examples of low-fat foods and advise them to choose foods that have a lower fat content.
• Advise them against adding less fat (butter, margarine or oils) to the foods that they prepare.
• They must develop healthy eating habits, like eating more fruits and vegetables.
• You must recommend that the patients should gradually increase their physical activity.
• The patients must be instructed that if they have to go to the hospital or if they are given a new prescription medicine, they should tell doctor(s) there that they are taking REESIZE.
• Please remember, losing weight can affect the dose of other medicines that your patients need, such as those for diabetes, high blood pressure or high cholesterol. Your may need to adjust the doses of other medicines that you may prescribe to these patients. For that reason, regular blood sugar and/or lipid profile as well as BMI monitoring may be necessary.
• If your patients have type 2 diabetes, they should follow your dietary recommendations and test blood sugar and HbA1c levels regularly.
• Ask your patients to register with www.reesize.com for relevant information, which may boost cooperation from your patients.

If your patients forget to take a dose, advise them it can be taken up to one hour after a meal and still be effective. Strictly advise them not to take double the amount if they miss one dose. However, it should also be kept in mind that REESIZE cannot work properly if many doses are missed.

Like any other medications, REESIZE may have some adverse effects. You need to explain your patients that they need to inform you immediately about the any adverse effects following REESIZE intake. The most common possible side effects from REESIZE are directly related to the way REESIZE works. By preventing the absorption of some dietary fat, explain while prescribing, it is likely that your patient will experience some change in bowel habits.  Assure that these effects are generally mild and transient. Also these adverse effects may increase if your patients 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 the bowel movement may be clear, orange or brown in colour. These bowel changes are a natural effect of unabsorbed fat and indicate that REESIZE is working.

• Explain that these unwanted side effects are more likely to occur if your patients eat meals that contain large amounts of fat. Sticking to a diet that contains no more than 30% of calories from fat in each meal will reduce side effects considerably.
• The patients should try to avoid eating fatty foods. Also advise that some unwanted side effects may go away during treatment as the body adjusts to the REESIZE.

• Sweating
• Dizziness
• Shakiness
• Hunger
• Confusion

indicating hypoglycemia. Ask your patients to report these symptoms if they occur and advise your patients about how they can avoid these symptoms and also consider whether the dosage of the anti-diabetic medications might need to be lowered or even discontinued.

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