THERAPEUTIC INDICATIONS : ORLY IS indicated in conjunction with a mildly hypocalorric diet for the treatment of obese patients with a body mass index ( BMI ) greater or equal to 30 kg/m2 , or overweight patients (BMI ≥ 28 KG/M2 ) WITH ASSOCIATED RISK FACTORS .
TREATMENT WITH ORILSTAT SHOULD BE discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy .

DOSAGE OF ORLY 30 CAP

Follow all directions given to you by your pharmacist or doctor carefully . They may differ from the information contained in this leaflet

Ask your pharmacist or doctor for help if you do not understand the instructions on the box .

The recommended dose is : –

Adults : the recommended dose of ORLY (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 ORLY 30 CAP (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 ORLY (Orlistat) above 120 mg three times daily have not been shown to provide additional benefit. The effect of ORLY (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 population : the effect of ORLY 30 CAP (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 ORLY 30 CAP (Orlistat) in children .

OVER-DOSAGE OF ORLY 30 CAP

Single doses of 800 mg ORLY (Orlistat) and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings.

In addition , doses of 240 mg that have been administered to obese patients for 6 months .

The majority of ORLY (Orlistat) overdose cases received during post – marketing reported either no adverse events or adverse events that are similar to those reported with recommended dose.

Should a significant overdose of ORLY 30 CAP (Orlistat) occur, it is recommended that the patient be observed for 24 hours based on human and animal studies, any systemic effects attributable to the lipase – inhibiting properties of ORLY 30 CAP (Orlistat) should be rapidly reversible.