Xenical

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

orlistat

Available from:

CHEPLAPHARM Arzneimittel GmbH

ATC code:

A08AB01

INN (International Name):

orlistat

Therapeutic group:

Antiobesity preparations, excl. diet products

Therapeutic area:

Obesity

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/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.

Product summary:

Revision: 25

Authorization status:

Authorised

Authorization date:

1998-07-29

Patient Information leaflet

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
XENICAL 120MG HARD CAPSULES
Orlistat
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor or your
pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Xenical is and what it is used for
2.
What you need to know before you take Xenical
3.
How to take Xenical
4.
Possible side effects
5.
How to store Xenical
6.
Contents of the pack and other information
1.
WHAT XENICAL IS AND WHAT IT IS USED FOR
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.
Xenical is indicated in the treatment of obesity in conjunction with a
low calorie intake diet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XENICAL
DO NOT TAKE XENICAL
•
if you are allergic (hypersensitive) to orlistat or to any of the
other ingredients of Xenical,
•
if you have chronic malabsorption syndrome (insufficient absorption of
nutrients from
alimentary tract),
•
if you have cholestasis (liver disorder)
•
if you are breast-feeding
WARNINGS AND PRECAUTIONS
Weight loss may also affect the dose of medicines taken for other
conditions (e.g. high cholesterol or
diabetes). Be sure to discuss these and other medicines you may be
taking with your doctor. Losing
weight may mean you need adjustments to t

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xenical 120 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 120 mg orlistat.
For a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
The capsule has a turquoise cap and turquoise body bearing the imprint
of “XENICAL 120”.
4.
CLINICAL PARTICULARS
4.1
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/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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults
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
discontinuation of therapy, faecal fat content usually returns to
pre-treatment levels, within 48 to 72
hours.
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 Xenical in children.
4.3
CONTRAINDICATIONS
-
Hypersensitivity to the active substance or to any of the excipients.
-
Chronic malabsorption syndrome.
-
Choles