Beacita 60mg capsules, hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ORLISTAT

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

A08AB01

INN (International Name):

ORLISTAT 60 mg

Pharmaceutical form:

HARD CAPSULE

Composition:

ORLISTAT 60 mg

Prescription type:

OTC

Therapeutic area:

ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2012-11-27

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BEACITA 60 MG CAPSULES, HARD
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 have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your 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.
-
If you do not lose weight after taking Beacita for 12 weeks, see your
doctor or pharmacist for
advice. You may need to stop taking Beacita.
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 used for weight loss in adults aged 18 and over who are
overweight, and have a body mass
index (BMI) of 28 or above. Beacita should be used along with a
reduced calorie, lower fat diet.
BMI is a way to find out if you have a healthy weight, or are
overweight, for your height. The chart
below will help you find out whether you are overweight and whether
Beacita is right for you.
Find your height on the chart. If you weigh less than the weight shown
for your height, do not take
Beacita.
HEIGHT
WEIGHT
HEIGHT
WEIGHT
1.50 m
63 kg
4' 10''
9st 8lbs
1.55 m
67.25 kg
5' 0''
10st 3lbs
1.60 m
71.75 kg
5' 2''
10st 13lbs
1.65 m
76.25 kg
5' 4''
11st 9lbs
1.70 m
81 kg
5' 6''
12st 5lbs
1.75 m
85.75 kg
5' 8''
13st 2lbs
1.80 m
90.75 kg
5' 10''
13st 13lbs
1.85 m
95.75 kg
6' 0''
14st 10lbs
1.90 m
101 kg
6' 2''
15st 8lbs
RISK OF BEING OVERWEIGHT
Being overweight increases your risk of developing several serious
health problems such as diabetes
and heart disease. These conditions may not cause you to feel unwell
so you should see your doctor
for

Summary of Product characteristics

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THE SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Beacita 60 mg capsules, hard
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
Capsule, hard.
The capsule has a light blue cap and light blue body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Beacitais 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 dose of Beacita is one 60mg capsule to be taken three
times daily.
No more than three 60 mg capsules should be taken in 24 hours.
Treatment should not exceed 6 months.
If patients have been unable to lose weight after 12 weeks of
treatment with Beacita they should
consult their doctor or a pharmacist. It may be necessary to
discontinue treatment.
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 Beacita.
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
2,000kcal/day diet, this equates to <67g 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 Beacita is
stopped.
_ _
_Special populations_
_ _
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_ _
_Paediatric population _
Beacita should not be used in children and adolescents below 18 years
of age due to insufficient data
on safety and efficacy.
_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 individual