Alli (previously Orlistat GSK)

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

orlistat

MAH:

GlaxoSmithKline (Ireland) Limited

ATC_code:

A08AB01

INN:

orlistat

therapeutic_group:

Antiobesity preparations, excl. diet products

therapeutic_area:

Obesity

therapeutic_indication:

Alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥ 28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.

leaflet_short:

Revision: 19

authorization_status:

Authorised

authorization_date:

2007-07-22

PIL

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALLI 60 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.
-
Ask your doctor or pharmacist if you need more information or advice.
-
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.
-
You must talk to your doctor or pharmacist if you do not lose weight
after taking alli
for 12 weeks. You may need to stop taking alli.
WHAT IS IN THIS LEAFLET
1.
What alli is and what it is used for
-
Risk of being overweight
-
How alli works
2.
What you need to know before you take alli
-
Do not take alli
-
Warnings and precautions
-
Other medicines and alli
-
alli with food and drink
-
Pregnancy and breast-feeding
-
Driving and using machines
3.
How to take alli
-
Preparing to lose weight
-
Choose your start date
-
Decide on your weight loss goal
-
Set your calorie and fat targets
-
Taking alli
-
Adults 18 and over
-
How long should I take alli for?
-
If you take more alli than you should
-
If you forget to take alli
4.
Possible side effects
-
Serious side effects
-
Very common side effects
-
Common side effects
-
Effects seen in blood tests
-
Learn to deal with diet-related treatment effects
5.
How to store alli
6.
Contents of the pack and other information
-
What alli contains
-
What alli looks like and contents of the pack
-
Marketing authorisation holder and manufacturer
-
Further helpful information
28
1.
WHAT ALLI IS AND WHAT IT IS USED FOR
alli 60 mg hard capsules (orlistat) is a peripherally acting
antiobesity product which is used for weight
loss in adults aged 18 and over who are overweight, and have a body
mass index (BMI) of 28 or
above. alli should be used along with a reduced calorie, lower-fat
diet.

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
alli 60 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 60 mg orlistat.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
The capsule has a dark blue centre band, and a turquoise cap and body
bearing the imprint of “alli”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
alli is indicated for weight loss in adults who are overweight (body
mass index, BMI,

28 kg/m
2
) and
should be taken in conjunction with a mildly hypocaloric, lower-fat
diet.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults _
The recommended treatment dose is one 60 mg capsule to be taken three
times daily. No more than
three 60 mg capsules should be taken in 24 hours.
Diet and exercise are important parts of a weight loss programme. It
is recommended that a diet and
exercise programme is started before beginning treatment with alli.
While taking orlistat, the patient should be on a nutritionally
balanced, mildly hypocaloric diet that
contains approximately 30% of calories from fat (e.g. in a 2,000
kcal/day diet, this equates to <67 g
of fat). The daily intake of fat, carbohydrate and protein should be
distributed over three main meals.
The diet and exercise programme should continue to be followed when
treatment with alli is stopped.
Treatment should not exceed 6 months.
If patients have been unable to lose weight after 12 weeks of
treatment with alli, they should consult
their doctor or a pharmacist. It may be necessary to discontinue
treatment.
_Special populations _
_Elderly (>65 years old) _
There are limited data on the use of orlistat in the elderly. However,
as orlistat is minimally absorbed,
no dose adjustment is necessary in the elderly.
3
_Hepatic and renal impairment _
The effect of orlistat in individuals with hepatic and/or renal
impairment has not been studied (see
section 4.4). However, as orlistat is minimally absorbed, no dose
adjustment is necessar