Xenical

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Orlistat 120mg;  ;  

Disponible des:

Pharmaco (NZ) Ltd

Designació comuna internacional (DCI):

Orlistat 120 mg

Dosis:

120 mg

formulario farmacéutico:

Capsule

Composición:

Active: Orlistat 120mg     Excipient: Gelatin Indigo carmine Microcrystalline cellulose Povidone Purified talc Sodium laurilsulfate Sodium starch glycolate TekPrint black SW-9008 Titanium dioxide

Unidades en paquete:

Blister pack, PVC/PVDC, 84 capsules

clase:

Restricted

tipo de receta:

Restricted

Fabricat per:

Roche Ireland Ltd

indicaciones terapéuticas:

Xenical is for weight control, including weight loss, weight maintenance and prevention of weight regain in adults with an initial body mass index (BMI) of 30 or more. Xenical should be used in conjunction with a low fat, calorie controlled diet.

Resumen del producto:

Package - Contents - Shelf Life: Blister pack, PVC/PVDC - 84 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture

Data d'autorització:

1997-02-04

Informació per a l'usuari

Xenical

CMI 220817
1 of 7
CONSUMER MEDICINE INFORMATION
XENICAL
®
ORLISTAT
120 MG CAPSULES
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 pharmacist or doctor.
All medicines have risks and benefits. Your pharmacist or doctor will
consider the risks of your taking
XENICAL capsules against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT XENICAL IS USED FOR
XENICAL contains the active ingredient orlistat.
XENICAL is used to assist with losing weight, maintaining a certain
weight and preventing weight
regain.
XENICAL is used to treat adults with an initial Body Mass Index (BMI)
which measures 30 or more.
One way to measure if you are overweight, and how overweight you are,
is to calculate your Body
Mass Index (BMI). You can calculate your BMI by multiplying your
height in metres by itself (squaring
your height in metres), and then dividing your weight in kilograms by
your squared height.
weight (kg) weight (kg)
BMI = ------------------------------- = --------------------
height (m) x height (m) [height (m)]
2
If your BMI is 25 or more you may be overweight, and if your BMI is 30
or more you may be very
overweight. BMI may vary across different populations due, in part, to
different body proportions. Talk
to your pharmacist or doctor if you have any questions about your BMI.
XENICAL should be taken in conjunction with a low-fat, well-balanced,
calorie-controlled diet and
other appropriate measures such as exercise.
XENICAL belongs to a group of medicines called lipase inhibitors.
These medicines work by
preventing the absorption of dietary fat in your body rather than by
suppressing your appetite.
Xenical

CMI 220817
2 of 7
Dietary fats are large molecules that need to be broken down before
they can be absorbed into the
body. They

Fitxa tècnica

NEW ZEALAND DATA SHEET
Xenical

003
May 2023
1
XENICAL® (120 MG CAPSULES)
Orlistat
1 PRODUCT NAME
Xenical® 120 mg capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 120 mg Orlistat
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard capsule.
Xenical 120 mg hard capsules have a turquoise cap and turquoise body
bearing the imprint of
“XENICAL 120”.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xenical is for weight control, including weight loss, weight
maintenance and prevention of weight
regain in adults with an initial body mass index (BMI) of 30 or more.
Xenical should be used in conjunction with a low fat,
calorie-controlled diet.
4.2
DOSE AND METHOD OF ADMINISTRATION
_ADULTS _
The recommended dose of Xenical is one 120 mg capsule orally three
times a day with each main
meal (during or up to one hour after the meal). If a meal is missed,
the dose of Xenical 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 above 120 mg three times daily have not been shown to provide
additional benefit.
The
World
Health Organisation
(WHO)
calculates
Body
Mass
Index
(BMI)
using
the
following
equation:
BMI = weight (kg)
[height (m)]
2
The WHO BMI classification for overweight adults is BMI ≥ 25, and
for obese adults BMI ≥ 30.
NEW ZEALAND DATA SHEET
Xenical

003
May 2023
2
Note, that these BMI values are age-independent and the same for both
sexes. However, BMI may
not correspond to the same degree of fatness across different
populations due, in part, to different
body proportions.
_RENAL IMPAIRMENT _
Clinical investigations in patients with renal impairment have not
been undertaken.
_HEPATIC IMPAIRMENT _
Clinical investigations in patients with hepatic impairment have not
been undertaken.
_ELDERLY