📌 COMPOSITION

Each capsule contains: Orlistat USP 120 mg.

📌 DESCRIPTION

Smart Look (Orlistat) is a potent, specific and long‑acting lipase inhibitor. It exerts its therapeutic activity in the lumen of the stomach and upper small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. These effects lead to prevention of hydrolysis of dietary fats in the form of triglycerides into absorbable free fatty acids and monoglycerides. Therefore, systemic absorption of Orlistat is not needed for activity. In vitro, more than 99% of Orlistat is bound to plasma proteins. The metabolism of Orlistat occurs mainly within the gastrointestinal wall, then approximately 97% of the administered dose is excreted in faeces. The excretion is completed within 3-5 days.

📌 INDICATIONS

Smart Look is indicated in the treatment of obese patients and overweight patients associated with risk factors such as type II diabetes, hyperlipidaemia and hypertension, in conjunction with a mildly hypocaloric diet. Treatment with Orlistat in non‑diabetic patients should be started only if diet alone has previously produced a weight loss of at least 2.5 kg over a period of 4 weeks.

📌 DOSAGE & ADMINISTRATION

The recommended dose of Smart Look is one capsule (120 mg) 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.
• The patient should be on a nutritionally balanced, mildly hypocaloric diet in which approximately 30% of the calories are from fat. The diet should be rich in fruit and vegetables, and the daily intake of fat, carbohydrate and protein should be distributed between three main meals.
• The duration of treatment with Orlistat should not exceed 2 years.
• 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.
• Orlistat is not intended for the treatment of children.

📌 RESTRICTIONS ON USE

Contraindications

• Patients who are sensitive to Orlistat.
• Patients with chronic malabsorption syndrome or patients with cholestasis.

Precautions

• The tolerability and efficacy of Orlistat have not been studied in children under 18 years of age, elderly patients, or patients with hepatic and/or renal impairment.
• The probability of occurrence of gastrointestinal side effects may increase when Orlistat is taken with a fatty meal.

Use in pregnancy and lactation

No clinical data are available on pregnancies exposed to Orlistat. It should not be used during breast‑feeding.

📌 DRUG INTERACTIONS

• Antidiabetic drug treatment should be closely monitored during Orlistat therapy.
• If Orlistat is co‑administered with Cyclosporine A, plasma concentration of Cyclosporine A should be closely monitored, and an interval of three hours between ingestion of Orlistat and Cyclosporine A is recommended.
• Concomitant administration of Orlistat with Acarbose, Thiazolidinediones (Glitazones), Glinides or anorectic drugs is not recommended.
• When anticoagulants are given in combination with Orlistat (in high dose or long‑term therapy), international normalized ratio (INR) values should be monitored.
• A therapeutic effect of Amiodarone may be reduced when used during Orlistat treatment.
• Hormonal contraceptive failure may occur in the event of severe diarrhoea with Orlistat, and patients are advised to use an additional contraceptive method.
• If a multivitamin supplement is recommended, it should be taken at least 2 hours after the ingestion of Orlistat or at bedtime.

📌 ADVERSE EFFECTS

The main adverse reactions of Orlistat are gastrointestinal, and the incidence of events decreases with prolonged use of Orlistat. The higher the fat content of the diet, the higher the incidence of these undesirable effects.

• The common side effects are: Oily spotting from the rectum, flatulence, faecal urgency, oily or fatty stool, increased defecation and faecal incontinence. Abdominal pain and watery stool can also occur.
• Other side effects are: Anxiety, headache, upper and lower respiratory tract infections, abdominal pain/discomfort, flatulence, rectal pain, tooth and gingival disorders, urinary tract infection, irregularity of menstruation and fatigue.
• Hypoglycaemia and feeling of abdominal tightness may appear in type II diabetic patients.
• Rare cases of hypersensitivity have been reported such as pruritus, rash, urticaria, angioedema and anaphylaxis.

📌 OVERDOSAGE

Doses above the recommended dose of (120 mg) three times daily do not lead to any appreciable increase in effect and may increase gastrointestinal side effects. If a significant overdose of Orlistat occurs, it is recommended that the patient should be observed for 24 hours, and any systemic effects attributable to the lipase‑inhibiting properties of Orlistat should be rapidly reversible.

📌 STORAGE INSTRUCTIONS

Store below 25°C. Protect from moisture.

📌 PHARMACEUTICAL FORMS

• Smart Look capsules: Pack of 30 capsules and hospital packs of different sizes.