Orlistat Accord 120 mg hard capsules

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Orlistat

Disponibbli minn:

Accord Healthcare Ireland Ltd.

Kodiċi ATC:

A08AB01

INN (Isem Internazzjonali):

Orlistat

Għamla farmaċewtika:

Capsule, hard

Żona terapewtika:

orlistat

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2023-07-28

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ORLISTAT ACCORD 120 MG HARD CAPSULES
orlistat
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
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 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 Orlistat Accord is and what it is used for
2.
What you need to know before you take Orlistat Accord
3.
How to take Orlistat Accord
4.
Possible side effects
5.
How to store Orlistat Accord
6.
Contents of the pack and other information
1.
WHAT ORLISTAT ACCORD IS AND WHAT IT IS USED FOR
Orlistat Accord 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 Accord 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 Accord is indicated in the treatment of obesity in
conjunction with a low calorie intake diet.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ORLISTAT ACCORD
DO NOT TAKE ORLISTAT ACCORD

if you are allergic (hypersensitive) to orlistat or to any of the
other ingredients of Orlistat
Accord,

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.

Karatteristiċi tal-prodott

Health Products Regulatory Authority
28 July 2023
CRN00CWV2
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Orlistat Accord 120 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 120 mg orlistat.
Excipient with known effect
Each hard capsule contains 69.2 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule.
Hard capsule (19.3 mm in diameter) with a turquoise cap and body with
LO1 imprinted in black.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Orlistat Accord 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 in