XENICAL orlistat 120mg capsule blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

orlistat, Quantity: 120 mg

Dostupno od:

Pharmaco Australia Ltd

Farmaceutski oblik:

Capsule, hard

Sastav:

Excipient Ingredients: lecithin; Gelatin; sodium lauryl sulfate; dimeticone 1510; indigo carmine; sodium starch glycollate; iron oxide black; titanium dioxide; microcrystalline cellulose; Shellac; purified talc; povidone

Administracija rute:

Oral

Jedinice u paketu:

84 capsules, 9 capsules, 42 capsules, 21 capsules

Tip recepta:

(S3) Pharmacist Only Medicine

Terapijske indikacije:

Xenical is indicated for the treatment of obese patients with a body mass index (BMI) >= 30, and overweight patients with a BMI >= 27 in the presence of other risk factors, in conjunction with a mildly hypocaloric diet.

Proizvod sažetak:

Visual Identification: Hard gelatin capsule, opaque turquoise, imprinted with black ink "XENICAL 120".; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2000-04-11

Uputa o lijeku

XENICAL® - Consumer Medicine Information 2021-04 v2.0
1
XENICAL
®
ACTIVE INGREDIENT(S): _orlistat_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
XENICAL capsules. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR
OR PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF
YOU HAVE ANY CONCERNS OR QUESTIONS ABOUT USING XENICAL.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1.
Why am I using XENICAL?
2.
What should I know before I use XENICAL?
3.
What if I am taking other medicines?
4.
How do I use XENICAL?
5.
What should I know while using XENICAL?
6.
Are there any side effects?
7.
Product details
1.
WHY AM I USING XENICAL?
XENICAL CONTAINS THE ACTIVE INGREDIENT ORLISTAT.
XENICAL IS USED TO TREAT PEOPLE WHO ARE OBESE (BMI ≥ 30)
OR OVERWEIGHT (BMI ≥ 27) WITH OTHER RISK FACTORS (E.G. HIGH
BLOOD PRESSURE, HIGH CHOLESTEROL, HIGH BLOOD LIPID PROFILE).
Your Body Mass Index (BMI) is calculated by dividing your
weight (in kg) by your height (in metres) squared.
XENICAL belongs to a group of medicines called lipase
inhibitors.
These medicines work by targeting the absorption of
dietary fat in your body rather than suppressing your
appetite.
Dietary fats are large molecules that need to be broken
down before they can be absorbed into the body. They are
broken down by enzymes called lipases. That is, lipases
play an important role in the digestion of dietary fat. 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. Therefore,
your body cannot store these excess calories as fatty tissue
or use them as a source of energy. This helps you to
reduce your weight by burning up fat that you are already
carrying, maintain your lower weight and minimise any
weight regain.
Losing even small amounts of weight and keeping it off
produces additional health benefits for you, especially
when you are at risk for other diseases such as heart
disease and diabetes. XENICAL can also help to improve
ri

Svojstava lijeka

1
2020-10 v1.2
AUSTRALIAN PRODUCT INFORMATION – XENICAL (ORLISTAT)
CAPSULES
1
NAME OF THE MEDICINE
Orlistat
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
XENICAL is available as hard gelatin capsules containing 120 mg of
orlistat.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
120 mg hard gelatin capsules (turquoise; opaque) with the marking
“XENICAL 120” printed
in black ink on the cap and body: blister packs of 42 and 84 capsules.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
XENICAL is indicated for the treatment of obese patients with a body
mass index (BMI)
≥ 30, and overweight patients with a BMI ≥ 27 in the presence of
other risk factors, in
conjunction with a mildly hypocaloric diet.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The recommended oral 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 dose of
XENICAL may be omitted. The therapeutic benefits of XENICAL (including
weight control
and improvement of risk factors) are continued with long-term
administration.
At the recommended therapeutic dose, the inhibition of the absorption
of approximately
one-third of dietary fat produces meaningful weight loss and reduces
risk factors. At the
same time, this effect allows absorption of adequate amounts of
dietary fat and other nutrients
that are essential for the maintenance of good health.
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.
Because XENICAL has been shown to reduce the absorption of some
fat-soluble vitamins
and beta-carotene, patients should be counselled to take a
multivitamin containing fat-soluble
vitamins to ensure adequate nutrition. The supplement should be taken
at least 2 hours before
or after the ad