Orsoten capsules

देश: आर्मेनिया

भाषा: अंग्रेज़ी

स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

सक्रिय संघटक:

orlistat

थमां उपलब्ध:

KRKA-RUS LLC

ए.टी.सी कोड:

A08AB01

INN (इंटरनेशनल नाम):

orlistat

डोज़:

120mg

फार्मास्यूटिकल फॉर्म:

capsules

पैकेज में यूनिट:

(21/3x7/) in blister, (21/1x21/), in blister, (42/6x7/) in blister, (42/2x21/), in blister

प्रिस्क्रिप्शन प्रकार:

Prescription

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2016-05-12

उत्पाद विशेषताएं

1.3.1
Orlistat
SPC, Labeling and Package Leaflet
AM
SmPCPIL156212_1
15.10.2020 – Updated: 15.10.2020
Page 1 of 7
1.
NAME OF THE MEDICINAL PRODUCT
Orsoten
®
120 mg capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 120 mg orlistat.
For Excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules are made from hypromellose. The body and the cap of the
capsule are white colour or
white with yellow cast. The content of the capsules are micro granules
or mixture of powder and micro
granules white or almost white colour. The presence of agglutinate
agglomerates, which quickly
dissipate at gently tension, is permitted.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Orsoten
®
is indicated for the long term treatment of obese patients with a body
mass index (BMI)
greater or equal to 30 kg/m
2
, or overweight patients (BMI ≥ 28 kg/m
2
), including those with associated
risk factors, in conjunction with a mildly hypocaloric diet.
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of orlistat is one 120 mg capsule taken per os
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
orlistat may 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 orlistat above 120 mg three times daily have not been shown
to provide additional benefit.
The effect of 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 populations
The effect