PROLISTAT orlistat 120 mg capsule blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

orlistat, Quantity: 120 mg

Tillgänglig från:

Boucher & Muir Pty Ltd

INN (International namn):

Orlistat

Läkemedelsform:

Capsule, hard

Sammansättning:

Excipient Ingredients: sodium lauryl sulfate; sodium starch glycollate type A; hydrophobic colloidal silica anhydrous; microcrystalline cellulose; titanium dioxide; indigo carmine; sorbitan monolaurate; Gelatin

Administreringssätt:

Oral

Enheter i paketet:

84, 42, 14

Receptbelagda typ:

(S3) Pharmacist Only Medicine

Terapeutiska indikationer:

Prolistat 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.

Produktsammanfattning:

Visual Identification: Hard gelatin, blue capsules; content is white powder or slightly compacted agglomerates; size of capsules ? No 1; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Bemyndigande status:

Licence status A

Tillstånd datum:

2016-01-29

Bipacksedel

1
PROLISTAT
®
Consumer Medicine Information
PROLISTAT
®
_ORLISTAT _
Capsule 120 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Prolistat.
This leaflet answers some common questions about Prolistat. It does
not contain all the
available information.
Reading this leaflet does not take the place of talking to your
pharmacist or doctor.
All medicines have risks and benefits. Your pharmacist or doctor has
weighed the risks
of you taking Prolistat against the benefits this medicine is expected
to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR
DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may want to read it again.
WHAT PROLISTAT IS USED FOR
Prolistat contains the active ingredient orlistat. It 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.
Prolistat 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, and
high blood lipid profile).
Your Body Mass Index (BMI) is calculated by dividing your weight (in
kg) by your height
(in metres) squared.
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. Lipases play
an important role in the digestion of dietary fat. When taken with a
meal, orlistat
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.
2
PROLISTAT
®
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

Produktens egenskaper

PROLISTAT
1
AUSTRALIAN PRODUCT INFORMATION
PROLISTAT
(ORLISTAT)
CAPSULES
1
NAME OF THE MEDICINE
Orlistat
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prolistat capsules contain orlistat 120 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
The capsules are hard gelatin capsules with blue cap and body (size
no. 1).
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prolistat 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 DOSE AND METHOD OF ADMINISTRATION
The recommended oral dose of Prolistat 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 Prolistat
may be omitted. The therapeutic benefits of Prolistat (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.
PROLISTAT
2
Because orlistat 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 administration of Prolistat, such as bedtime.
In the 4-year clinical trial, patients took vitamin supplemen