XENICAL Capsule 120 mg

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

ORLISTAT

Tillgänglig från:

ROCHE (MALAYSIA) SDN. BHD.

INN (International namn):

ORLISTAT

Enheter i paketet:

42Capsule Capsules; 21Capsule Capsules; 84Capsule Capsules

Tillverkad av:

ROCHE S.P.A.

Bipacksedel

XENICAL
®
Orlistat (120 mg capsules)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
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 Xenical
6. Side effects
7. Storage and disposal of
Xenical
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
11. 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

Produktens egenskaper

PACK INSERT FOR MALAYSIA
Xenical PPPPPPP ®
PP PP PP P
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 glycollate, povi -
done, 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 “ROCHE
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  30kg/m PPP PPPP 2 PPP
P PP P
) and overweight (BMI  28kg/m PPP PPPP 2 PPP
P PP P
) 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 reduc -
tion of visceral fat.
In type 2 diabetic patients who are overweight (BMI  28kg/m PPP PPPP 2 PPP
P PP P
) or obese
(BMI  30kg/m PPP PPPP 2 PPP
P PP P
) Xenical, in conjunction with a mildly hypocaloric diet, pro -
vides 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 2.5kg 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