Body slend

Body Slend  (Orlistate 120 mg)

Dosage form : Hard Gelatin Capsule

1-Composition:

Each Hard Gelatin Capsule contains:

Active ingredients: Orlistate 120 mg

Inactive ingredients: Microcrystalline cellulose PH 101, Sodium starch glycolate, Crospovidone XL-10, Talc, Povidone K25, Sodium lauryl sulphate,Gelatin, Titanium dioxide, Brilluant blue, Carmoisine

2-Therapeutic indications

Body Slend is indicated in conjunction with a mildly hypocaloric 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 orlistat 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.

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 Body Slend in children.

Category:
Contraindications
Interaction with other medicinal products and other forms of interaction
Fertility, pregnancy and lactation
Pharmacological properties Pharmacodynamic properties
Pharmacokinetic properties:
STORAGE INSTRUCTIONS:
PACKAGE

Contraindications

Hypersensitivity to the active substance or to any of the excipients. - Chronic malabsorption syndrome. - Cholestasis. - Breast-feeding.

Interaction with other medicinal products and other forms of interaction

Ciclosporin Acarbose Oral anticoagulants Fat soluble vitamins Amiodarone

Fertility, pregnancy and lactation

For orlistat no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development . Caution should be exercised when prescribing to pregnant women. As it is not known whether orlistat is secreted into human milk, orlistat is contra-indicated during breast-feeding. There was an unexplained increase in the incidence of bone fractures in adolescents treated with orlistate.

Pharmacological properties Pharmacodynamic properties

Pharmaco-therapeutic group: Peripherally acting antiobesity agent. Orlistat is a potent, specific and long-acting inhibitor of gastrointestinal 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.

Pharmacokinetic properties:

Absorption the extent of absorption of orlistat is minimal. Plasma concentrations of intact orlistat were non-measurable (< 5 ng/ml) eight hours following oral administration of orlistat. In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 ng/ml or 0.02 µmol), with no evidence of accumulation, which is consistent with minimal absorption.

STORAGE INSTRUCTIONS:

Store at a temp. not exceeding 30 ºC in dry place.

PACKAGE

Carton box containing ( AL / transparent PVC) strips each of 10 Hard Gelatin Capsule + inner leaflet

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