GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Orlistat Capsules USP 60mg (FETRASIL)
2. Orlistat Capsules USP 120mg (FETRASIL)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Orlistat Capsules USP 60mg
Each hard gelatin Capsules contains:
Orlistat USP…………………..60mg
(As Pellets)
Excipients……………………..q.s.
Approved colours used in capsule shells.

2. Orlistat Capsules USP 120mg
Each hard gelatin Capsules contains:
Orlistat USP…………………120mg
(As Pellets)
Excipients……………………q.s.
Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Orlistat is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Taking orlistat can also help keep you from gaining back weight you have lost. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. Dietary fats need to be broken down into smaller pieces before the body can absorb them. Orlistat works by blocking the enzyme that breaks down fats in your diet. This undigested fat then passes out of your body in your bowel movement. Orlistat does not block the absorption of calories from sugar and other non-fat foods, so you still need to restrict your total intake of calories.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A REGISTERED MEDICAL PRACTITIONER.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.
Dosage: As directed by the Physician

Orlistat Capsules USP 60mg Technical Specification:

Product Name: Orlistat Capsules USP
Brand Name: FETRASIL
Strength: 60mg, 120mg
Dosage Form: Capsules (Hard gelatin)
Route of Administration: Via Oral Route
Packing: 10s, 30s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Anticholesterol
Indication: Orlistat (prescription and nonprescription) is used with an individualized low-calorie, low-fat diet and exercise program to help people lose weight. Prescription orlistat is used in overweight people who may also have high blood pressure, diabetes, high cholesterol, or heart disease.
Storage: Store below 30°C. Protect from Light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Orlistat Capsules USP 60mg
2. Orlistat Capsules USP 120mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Orlistat Capsules USP 60mg
Each hard gelatin Capsules contains:
Orlistat USP……………………..60mg  
(As Pellets)
Excipients……………………………q.s.
Approved colours used in capsule shells.

2. Orlistat Capsules USP 120mg
Each hard gelatin Capsules contains:
Orlistat USP……………………120mg
(As Pellets)
Excipients…………………………q.s.
Approved colours used in capsule shells.

THERAPEUTIC INDICATIONS:

Orlistat is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Taking orlistat can also help keep you from gaining back weight you have lost. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life. Dietary fats need to be broken down into smaller pieces before the body can absorb them. Orlistat works by blocking the enzyme that breaks down fats in your diet. This undigested fat then passes out of your body in your bowel movement. Orlistat does not block the absorption of calories from sugar and other non-fat foods, so you still need to restrict your total intake of calories.

CAUTION & SCHEDULE:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

SCHEDULE: SCHEDULE H: NOT TO BE SOLD BY RETAIL WITHOUT THE PRESCRIPTION OF A registered medical practitioner.

STORAGE & DOSAGE:

Storage: Store below 30°C.
Protect from Light and moisture.

Dosage: As directed by the Physician