XENICAL Capsule 120 mg

Country: Малезија

Језик: Енглески

Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активни састојак:

ORLISTAT

Доступно од:

DKSH MALAYSIA SDN BHD

INN (Међународно име):

ORLISTAT

Јединице у пакету:

42Capsule Capsules; 21Capsule Capsules; 84Capsule Capsules

Произведен од:

Delpharm Milano s.r.l

Информативни летак

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
XENICAL
®
Orlistat (120 mg capsules)
WHAT IS IN THIS LEAFLET
1.
What Xenical is used for
2.
How Xenical works
3.
Before you use Xenical
4.
How to use Xenical
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
Xenical
8.
Product Description
9.
Manufacturer
10.
Product
Registration Holder
11.
Date of revision
12.
Serial Number
WHAT XENICAL IS USED FOR
Xenical contains the active ingredient
orlistat.
Xenical is indicated in the treatment of
obesity in conjunction with a low calorie
intake diet.
Xenical is effective in weight loss, weight
maintenance and prevention of weight
regains.
Ask your doctor if you have any
questions about why Xenical has been
prescribed for you.
HOW XENICAL WORKS
XENICAL belongs to a group of
medicines called lipase inhibitors.
Xenical is a medicine used to treat
obesity. It works in your digestive system
to block about one-third of the fat in the
food you eat from being digested.
Xenical attaches to the enzymes in your
digestive system (lipases) and blocks
them from breaking down some of the fat
you have eaten during your meal. The
undigested fat cannot be absorbed and is
eliminated by your body.
BEFORE YOU USE XENICAL
-
_When you must not use it _
Do not take or receive XENICAL if:
•
you have had an allergic reaction to
Xenical (orlistat) or any ingredients
listed at the end of this leaflet
•
you have chronic malabsorption
syndrome (insufficient absorption of
nutrients from alimentary tract)
•
you have cholestasis (liver disorder)
•
you are breast-feeding
•
the package is torn or shows signs of
tampering
•
the expiry date (EXP) printed on the
pack has passed. If you take this
medicine after the expiry date has
passed, it may not work as well.
If you are not sure you should be taking
Xenical, talk to your doctor.
-
_Before you start to use it _
Tell your doctor if:
•
you are pregnant or plan to become
pregnant. Xenical is not
recommended for use during
pregnancy.
•
you are breast feeding or intend to
bre

Карактеристике производа

PACK INSERT FOR MALAYSIA
XENICAL
®
Orlistat
1.
DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGICAL CLASS OF
DRUG
Peripherally acting anti-obesity agent
1.2
TYPE OF DOSAGE FORM
Capsule, hard
1.3
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient:_ orlistat
Capsules 120 mg.
_Excipients:_ Capsule filling: microcrystalline
cellulose, sodium starch glycolate, povidone,
sodium lauryl sulphate and talc.
Capsule shell: gelatine, indigo carmine (E132)
and titanium dioxide (E171)
It is presented as turquoise cap and turquoise
body bearing the imprint of “XENICAL 120”. 2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATIONS
Xenical is indicated, in conjunction with a mildly
hypocaloric diet for the treatment of obese (BMI
≥
30 kg/m
2
) and overweight (BMI
≥
28 kg/m
2
)
patients, including patients with risk factors
associated with obesity. Xenical is effective in
weight loss, weight maintenance and prevention
of weight regains. Treatment with Xenical
results in an improvement of risk factors and
comorbidities associated with obesity, including
hypercholesterolemia, noninsulin dependent
diabetes mellitus (NIDDM), impaired glucose
tolerance, hyperinsulinemia, hypertension and in
a reduction of visceral fat.
In type 2 diabetic patients who are overweight
(BMI
≥
28 kg/m
2
) or obese (BMI
≥
30 kg/
m
2
) Xenical, in conjunction with a mildly
hypocaloric diet, provides additional
glycemic control when used in combination
with antidiabetic agents such as metformin,
sulfonylurea and/or insulin.
Treatment with Xenical should only be started if
diet alone has previously produced a weight loss
of at least 2.5 kg over a period of 4 consecutive
weeks. 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 drug therapy.
2.2
DOSAGE AND ADMINISTRATION
_Standard Dosage_
The recommended dose of Xenical is one 120
mg capsule with each main meal (during or up
to one hour after the meal). If a meal is missed
or contains no fat, the do