| Composition | : | Diet slim 120:Each hard capsule contains 120 mg orlistat. |
|---|---|---|
| Exipients | : | Microcrystalline cellulose, Sodium starch glycolate, Povidone, Sodium lauryl sulphate, Talc. |
| INDICATIONS | : | Diet slim 60:is indicated for weight loss in adults who are over weight ,body mass index(BMI ≥28 kg/m²) and should be taken in conjunction with a mildly hypocaloric lower-fat diet. Diet slim120:is indicated in conjunction with a mildly hypocaloric lower-fat diet for the treatment of obese patients with a body mass index (BMI greater or equal to 30 kg/m²), or over weight patients (BMI > 28 kg/m²) with associated risk factors. |
| Pharmacodynamic properties | : | Orlistat is an antiobesity agent.It is a potent, specific and long-acting inhibitor of gastro intestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases. The inactivated enzyme is thus unavailable to hydrolyse dietary fat, in the form of triglycerides, into absorbable free fatty acids and monoglycerides. |
| Contraindications | : | - Hypersensitivity to the active substance or to any of the Excipients. - Chronic malabsorption syndrome. - Cholestasis. - Breast-feeding. |
| Warnings | : | - Co-administration of Orlistat with ciclosporin is not recommended. - If Orlistat is taken with a meal very high in fat, the possibility of gastro intestinal adverse reactions may increase. |
| Drug Interactions | : | - Ciclosporin: A decrease in ciclosporin plasma levels has been observed in a drug-drug-interaction study and also reported in several cases, when Orlistat was administered concomitantly. This can lead to a decrease of immunosuppressive efficacy. - Acarbose: In the absence of pharmacokinetic interaction studies, the concomitant administration of orlistat with acarbose should be avoided. - Oral anticoagulants: When warfarin or other anticoagulants are given in combination with orlistat, international normalized ratio (INR) values should be monitored. - Fat soluble vitamins: Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K). - Amiodarone: A slight decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received orlistat concomitantly. |
| Pregnancy and lactation | : | pregnancy For Orlistat no clinical data on exposed pregnancies are available. Caution should be exercised when prescribing to pregnant women. lactation As it is not known whether Orlistat is secreted into human milk, Orlistat is contra-indicated during breast-feeding. |
| Undesirable effects | : | Headache, Upper respiratory infection, Lower respiratory infection, Abdominal pain/discomfort, Oily spotting, Flatus with discharge, Fecal urgency, Fatty/oily stool, Flatulence, Rectal pain/discomfort Soft stools, Fecal incontinence, Abdominal distension. Tooth and Gingival disorder. Urinary tract infection, Hypoglycemia, Fatigue, Menstrual irregularity, Anxiety. |
| DOSAGE | : | Diet slim 60 mg: Adults:The recommended dose of Orlistat is one 60 mg capsule to be taken three times daily. Treatment should not exceed 3 months. Diet slim120 mg: Adults: The recommended dose of Orlistat is one 120 mg capsule taken with water 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. The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30 % of calories from fat. It is recommended that the diet should be rich in fruit and vegetables. The daily intake of fat, carbohydrate and protein should be distributed over three main meals. Doses of orlistat above 120 mg three times daily have not been shown to provide additional benefit. The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing. Upon discontinuation of therapy, faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours. Special populations The effect of Orlistat in patients with hepatic and/or renal impairment, children and elderly patients has not been studied. There is no relevant indication for use of orlistat in children. |
| Packaging | : | Diet slim 120: A pack of 20 capsules. |
| Storage | : | Store below 25⁰C. |