Beacita 120mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Orlistat

Available from:

Actavis UK Ltd

ATC code:

A08AB01

INN (International Name):

Orlistat

Dosage:

120mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04050100; GTIN: 5012617023094

Patient Information leaflet

* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
PROOF ROUND
[e-mail]
Technical
Approval
NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item number:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
3.
FMD info
NA (not a carton)

No

Yes

Details
BEACITA (ORLISTAT) 120MG 84 HARD CAPSULES PIL - UK
Black
Profile
BBBA6724
R.Paul
22.10.2019
05.11.2019
R.Paul
165x500
9pt
Rontis
22.10.2019
25.10.2019
3
Version 2
01.11.2017
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, please ask your doctor, pharmacist
or nurse.
•
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, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Beacita is and what it is used for
2. What you need to know before you take Beacita
3. How to take Beacita
4. Possible side effects
5. How to store Beacita
6. Contents of the pack and other information
1. WHAT BEACITA IS AND WHAT IT IS USED FOR
Beacita 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.
Beacita 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.
Beacita is indicated in the treatment of obesity in conjunction with a
low calorie intake diet.
2. WHAT YOU

Summary of Product characteristics

OBJECT 1
BEACITA 120MG CAPSULES, HARD
Summary of Product Characteristics Updated 19-Oct-2017 | Accord-UK Ltd
1. Name of the medicinal product
Beacita 120mg Capsules, hard
2. Qualitative and quantitative composition
Each hard capsule contains 120mg 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
Beacita 120mg Capsules are 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/m
2
, or overweight patients (BMI ≥
28 kg/m
2
) 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
Posology
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 Beacita 120mg Capsules in
children.
_Elderly (>65 years old) / Patients with hepatic and renal impairment_
The effect of orlistat in elderly patients has