Orlistat 120mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Orlistat

Available from:

Teva UK Ltd

ATC code:

A08AB01

INN (International Name):

Orlistat

Dosage:

120mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04050100; GTIN: 5017007014089

Patient Information leaflet

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ORLISTAT 120 MG CAPSULES,
HARD
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, 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.
1. What Orlistat 120 mg Capsules are and
what they are used for
2. What you need to know before you take
Orlistat 120 mg Capsules
3. How to take Orlistat 120 mg Capsules
4. Possible side effects
5. How to store Orlistat 120 mg Capsules
6. Contents of the pack and other
information
WHAT ORLISTAT 120 MG CAPSULES
ARE AND WHAT THEY ARE USED FOR
Orlistat Capsules 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.
Orlistat 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.
Orlistat Capsules is indicated in the
treatment of obesity in conjunction with a
low calorie intake diet.
WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ORLISTAT 120 MG CAPSULES
DO NOT TAKE ORLISTAT CAPSULES
•
if you are allergic to orlistat or any
of the other ingredients of this
medicine (listed in section 6)
•
if you have chronic malabsorption
syndrome (insufficient absorption
of nutrients across the
gastrointestinal (GI) tract)
•
if you have cholestasis (liver
disorder)
•
if you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Orlistat Capsules.
Weight loss may also affect the dos

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Orlistat 120 mg capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule, hard contains 120 mg orlistat.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
The capsule has a blue cap and blue body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Orlistat 120 mg capsules 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
_Paediatric population _
The effect of orlistat in children has not been studied.
There is no relevant indication for use of Orlistat in children.
_Elderly (>65 years old) _
_ _
The effect of orlistat in elderly patients has not been studied.
_ _
_ _
_Hepatic and renal impairment_
The effect of orlistat in patients with hepatic and/or renal
impairment has no