Orlistat 120mg Capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Orlistat

Available from:

Alissa Healthcare Research Limited

ATC code:

A08AB; A08AB01

INN (International Name):

Orlistat

Dosage:

120 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Peripherally acting antiobesity products; orlistat

Authorization status:

Not marketed

Authorization date:

2016-01-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ORLISTAT 120 MG CAPSULES, HARD
ORLISTAT
WHAT IS IN THIS LEAFLET
1. What Orlistat is and what it is used for
2. What you need to know before you take Orlistat
3. How to take Orlistat
4. Possible side effects
5. How to store Orlistat
6. Contents of the pack and other information
1. WHAT ORLISTAT IS AND WHAT
IT IS USED FOR
Orlistat 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 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 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
DO NOT TAKE ORLISTAT:
• if you are allergic (hypersensitive) to orlistat or to any
of the other ingredients of Orlistat,
• 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. high cholesterol or diabetes).
Be sure to discuss these and other medicines you may
be taking with your doctor. Losing weight may mean you
need adjustments to the dose of these medicines.
To gain the maximum benefit from Orlistat you should
follow the nutrition program recommended to you by
your doctor. As with any weight-control program, over-
consumption of fat and calories may reduce any weight
loss effect.
This medicine can cause harmless changes in your bowel
habits, such as fatty or oily stools, due to the elimination
of undigested fat in your faeces. The possibility of this
happening may increase if Orlistat is taken with a diet
high in fat. In addition your daily intake of fat should
be distributed evenly over three main meals

Summary of Product characteristics

Health Products Regulatory Authority
18 September 2020
CRN009N4M
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Orlistat 120mg Capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 120 mg orlistat.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard Capsule
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Orlistat 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 indication for use of Orlistat in children.
4.3 CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
- Chronic malabsorption syndrome.
- Chole