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Indications - Adults: Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI)>30 kg/m2 and overweight patients (BMI >28 kg/m2 ) with associated risk factors such as type II diabetes, hyperlipidemia and hypertension. Treatment with Orlistat should be discontinued after 12 weeks in patients who have not lost at least 5% of their body weight as measured at the start of drug therapy. Adolescents (12 years & older): Obese adolescents should be treated with Orlistat only if an adequate reduction of body weight cannot be achieved by means of diet & increased physical activity. Treatment with orlistat should be considered in particular if complications of obesity are present.

Dosage & Administration - The recommended dose of Orlistat is one 120 mg capsule to be taken immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat the dose of Orlistat should be omitted. Doses of Orlistat above 120 mg three times daily have not been shown to provide additional benefits. The effect of Orlistat results in an increase in fecal fat 24-48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48-72 hours. The safety & efficacy of Orlistat were investigated in clinical studies lasting up to 4 years. The recommended dose of Orlistat for adolescents is as same as adults. Special dosage instruction: The tolerability and efficacy of Orlistat have not been studied in elderly patients, or patients with hepatic and/ or renal impairments.

Side Effects - Common: Undesirable effects of Orlistat are largely gastrointestinal in nature. Common gastrointestinal side effects are oily spotting from the rectum, flatulence, fecal urgency, oily or fatty stool, abdominal discomfort etc. Rare: Influenza, anxiety. headache, fatigue etc may rarely occur in some patients. Rare cases of hypersensitivity have been reported. Main clinical symptoms are pruritus, exanthema, urticaria, angioedema and anaphylaxis.

Contraindications - Orlistat is contraindicated in patients with chronic malabsorption syndrome, in patients with cholestasis and in patients who are hypersensitive to orlistat or to any of the other ingredients of the capsules.

Others - Use in pregnancy & lactation: No clinical data are available on pregnancy exposed to Orlistat. As it is not known whether Orlistat is excreted in breast milk. Orlistat should not be used during breastfeeding. Overdose Effects Single doses of 800 mg Orlistat and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings. Storage Conditions Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.