Alli 60mg capsules

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Last ned Preparatomtale (SPC)
15-06-2018

Aktiv ingrediens:

Orlistat

Tilgjengelig fra:

GlaxoSmithKline Consumer Healthcare

ATC-kode:

A08AB01

INN (International Name):

Orlistat

Dosering :

60mg

Legemiddelform:

Capsule

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: ; GTIN: 5000347034152 5000347033490 5000347040306

Informasjon til brukeren

                                information for the user
60 mg hard capsules
orlistat
31041819
visit
alli and SHUTTLE are registered trade marks of the GSK group of
companies.
The SHUTTLE carry case is a trade mark of the GSK group of companies.
www.alli.co.uk
www.alli.ie
2
3
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
4
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
5
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
8
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8
WHAT ALLI IS AND WHAT IT IS USED FOR
THIS CHAPTER CONTAINS:
■
Risk of being overweight
■
How alli works
9
1
9
WHAT ALLI IS AND
                                
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Preparatomtale

                                OBJECT 1
ALLI 60 MG HARD CAPSULES
Summary of Product Characteristics Updated 26-Jul-2017 |
GlaxoSmithKline Consumer Healthcare
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, lowerfat
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.
_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
                                
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