Nhà máy Stada
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Anti - Obesity

Orlistat STADA® 120MG

 

Pack size:                 

Box of 2 blisters x 21 capsules.


Compsition:

Each capsule contains orlistat (as orlistat pellets) 120 mg.


Shelf-life:

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.


 

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients as well as to reduce the risk for weight regain subsequent to initial loss in 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 (e.g., hypertension, diabetes mellitus, hyperlipidemia).
  • Management of obesity and weight regain in adults and adolescents 12 years of age and older: 120 mg three times daily with each main meal containing fat.
  • Over weight adults 18 years of age and older: 60 mg three times daily with each meal containing fat.
  • The capsule should be taken with water immediately before, during or up to 1 hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted.
  • Dosage exceeding three times daily have not been shown to provide additional benefit.
  • If patients have been unable to lose weight after 12 weeks of treatment with orlistat, they should consult their doctor or a pharmacist. It may be necessary to discontinue treatment.

Remarks

  • Diet and exercise are important parts of a weight loss programme. It is recommended that a diet and exercise programme is started before beginning treatment with orlistat.
  • The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat. The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
  • The diet and exercise programme should continue to be followed when treatment with orlistat is stopped.
  • The safety and effectiveness beyond 4 years have not been determined at this time.
  • Pediatric use: Safety and efficacy in children younger than 12 years of age has not been established.
  • There are limited data on the use of orlistat in the elderly. The effect of orlistat in individuals with hepatic and/or renal impairment has not been studied. However, as orlistat is minimally absorbed, no dosage adjustment is necessary in elderly and in individuals with hepatic and/or renal impairment.


Or as advised by physicians.

 

  • Hypersensitivity to orlistat or to any ingredient of the drug.
  • Chronic malabsorption syndrome or cholestasis.

     

  • Gastrointestinal disturbances, including faecal urgency and incontinence, flatulence, and fatty stools or discharge, are the most frequently reported adverse effects during treatment with orlistat, especially when taken with a high-fat diet.
  • Other reported effects have included headache, anxiety, fatigue, rectal bleeding, and menstrual irregularities (rarely).
     

  • Orlistat should be given with caution to patients with a history of hyperoxaluria or calcium oxalate nephrolithiasis. Adjustments to dosage of hypoglycaemics may be necessary in patients with type II diabetes because of improved metabolic control after weight loss in these patients. Supplements of fat-soluble vitamins may be necessary during long-term therapy, but they should be taken at least 2 hours before or after an orlistat dose or at bedtime.
  • Hormonal contraceptive failure may occur in the event of severe diarrhoea with orlistat, and patients are advised to use an additional contraceptive method.
  • Pregnancy: There are no adequate and well - controlled studies of orlistat in pregnant women. Orlistat is not recommended for use during pregnancy.
  • Lactation: It is not known if orlistat is distributed in breast milk. Therefore, orlistat should not be taken by nursing women.
  • Orlistat has no influence on the ability to drive and use machines.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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