XENICAL CAPSULE 120MG

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

ORLISTAT

متاح من:

DKSH SINGAPORE PTE. LTD.

ATC رمز:

A08AB01

جرعة:

120MG

الشكل الصيدلاني:

CAPSULE

تركيب:

ORLISTAT 120MG

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

Pharmacy Only

المصنعة من قبل:

F. Hoffman-La Roche Ltd

الوضع إذن:

ACTIVE

تاريخ الترخيص:

2005-01-31

نشرة المعلومات

1
XENICAL
® CAPSULE 120 MG
PATIENT INFORMATION LEAFLET
Please read this leaflet carefully because it contains important
information for you.
If you want to know more about this product, or if you are not sure
about a
particular item in the leaflet please ask your doctor or pharmacist.
WHAT IS IN THIS LEAFLET?
•
This leaflet answers some common questions about XENICAL capsules. It
does not contain all the available information. It does not take the
place of
talking to your doctor or pharmacist.
•
If you have any concerns about taking this medicine, ask your doctor
or
pharmacist.
•
Keep this leaflet with the medicine. You may need to read it again.
WHAT IS XENICAL
®
?
Each XENICAL capsule contains 120 mg of the active substance orlistat.
The
capsule also contains the additional excipients microcrystalline
cellulose, sodium
starch glycollate, povidone, sodium lauryl sulphate and talc. The
capsule shell
consists of gelatin, indigo carmine (E132), titanium dioxide (E171)
and edible
printing ink.
XENICAL is supplied as hard capsules in blister packs.
WHAT IS XENICAL
® TAKEN FOR?
XENICAL is used to treat people who are obese with a body mass index
(BMI)
greater or equal to 30 kg/m
2
, or overweight patients (BMI greater or equal to 28
kg/m
2
) with obesity-related risk factors.
Your Body Mass Index (BMI) is calculated by dividing your weight (in
kg) by
your height (in metres) squared.
Treatment with XENICAL should be discontinued after 12 weeks if you
are
unable to lose at least 5% of your body weight as measured at the
start of drug
therapy.
XENICAL belongs to a group of medicines called lipase inhibitors.
XENICAL
targets the absorption of fat in your body rather than suppressing
your appetite.
Dietary fats are large molecules which need to be broken down by
enzymes called
lipases before they can be absorbed into the body. When taken with a
meal,
XENICAL interferes with the activity of these enzymes. This allows
about 30% of
the fat eaten in the meal to pass through the gut undigested. Your
body therefore
cann

خصائص المنتج

1
XENICAL
®
ORLISTAT
1.
PHARMACEUTICAL FORM
XENICAL 120 mg hard capsules. The capsule has a turquoise cap and
turquoise body bearing the imprint
of
“XENICAL 120”.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 120 mg orlistat.
For excipients, see section 5.1.
3.
CLINICAL PARTICULARS
3.1
THERAPEUTIC INDICATIONS
Xenical 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/m
2
,
or overweight patients (BMI ≥ 28
kg/m
2
) with associated risk factors.
Treatment with Xenical should be discontinued after 12 weeks if
patients have been unable to lose at
least 5% of their body weight as measured at the start of drug
therapy.
In type 2 diabetic patients who are overweight (BMI ≥ 28kg/m
2
) or obese (BMI ≥ 30kg/m
2
), clinical
studies conducted over one year showed Xenical, in conjunction with a
mildly hypocaloric diet, provides
additional glycemic control when used in combination with
anti-diabetic agents such as metformin,
sulfonylurea and/or
insulin. No studies have been done in patients receiving concomitant
treatment with
thiazolidinedione. The efficacy of Xenical as a monotherapy treatment
for type 2 diabetes has not been
established.
3.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose of 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 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 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
disc