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Active substance(s): ORLISTAT

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Package leaflet: Information for the user

Orlistat 120 mg Capsules, hard
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, ask your doctor
or pharmacist.
– 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
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet

Other medicines and Orlistat
Please inform your doctor or pharmacist if you are taking
or have recently taken any other medicines, even those
not prescribed.
This is important as using more than one medicine at the
same time can strengthen or weaken the effects of the
Orlistat may modify the activity of:
• Anticoagulant drugs (e.g. warfarin). Your doctor may
need to monitor your blood coagulation.
• Ciclosporin. Co-administration with ciclosporin is not
recommended. Your doctor may need to monitor your
ciclosporin blood levels more frequently than usual.

2. What you need to know before you take Orlistat

• Iodine salts and/or levothyroxine. Cases of
hypothyroidism and/or reduced control of
hypothyroidism may occur.

3. How to take Orlistat

• Amiodarone. You may ask your doctor for advice.

4. Possible side effects

• Medicines to treat HIV.

5. How to store Orlistat

• Medicines for depression, psychiatric disorders or

1. What Orlistat is and what it is used for

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
• 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, overconsumption 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 because
if Orlistat is taken with a meal very high in fat, the
possibility of gastrointestinal effects may increase.
The use of an additional contraceptive method is
recommended to prevent possible failure of oral
contraception that could occur in case of severe
The use of orlistat may be associated with renal stones
in patients suffering from chronic kidney disease. Inform
your doctor whether you suffer from problems with your
Orlistat is not intended to be used in children.

Orlistat reduces the absorption of supplements of some
fat soluble nutrients, particularly beta-carotene and
vitamin E. You should therefore follow your doctor’s
advice in taking a well-balanced diet rich in fruit and
vegetables. Your doctor may suggest you take a
multivitamin supplement.
Orlistat may unbalance an anticonvulsivant treatment,
by decreasing the absorption of antiepileptic drugs,
thus leading to convulsions. Please contact your doctor
if you think that the frequency and/or severity of the
convulsions have changed when taking Orlistat together
with antiepileptic drugs.
Orlistat is not recommended for people taking acarbose
(an anti-diabetic drug used to treat type 2 diabetes
Orlistat with food and drink
Orlistat can be taken immediately before, during a meal
or up to one hour after a meal. The capsule should be
swallowed with water.
Pregnancy and breast-feeding
Taking Orlistat during pregnancy is not recommended.
You must not breast-feed your infant during treatment
with Orlistat as it is not known whether Orlistat passes
into human milk.
Driving and using machines
Orlistat has no known effect on your ability to drive a car
or operate machinery.
3. How to take Orlistat
Always take Orlistat exactly as your doctor has told you.
You should check with your doctor or pharmacist if you
are not sure. The usual dose of Orlistat is one 120 mg
capsule taken with each of the three main meals per day.
It can be taken immediately before, during a meal or up to
one hour after a meal. The capsule should be swallowed
with water.
Orlistat should be taken with a well-balanced, calorie
controlled diet that is rich in fruit and vegetables and
contains an average of 30 % of the calories from fat. Your
daily intake of fat, carbohydrate and protein should be
distributed over three meals. This means you will usually
take one capsule at breakfast time, one capsule at lunch
time and one capsule at dinner time. To gain optimal
benefit, avoid the intake of food containing fat between
meals, such as biscuits, chocolate and savoury snacks.
Orlistat only works in the presence of dietary fat.
Therefore, if you miss a main meal or if you have a meal
containing no fat, Orlistat need not be taken.
Tell your doctor if, for any reason, you have not taken
your medicine exactly as prescribed. Otherwise, your
doctor may think that it was not effective or well
tolerated and may change your treatment unnecessarily.
Continued overleaf...

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Your doctor will discontinue the treatment with Orlistat
after 12 weeks if you have not lost at least 5 % of your
body weight as measured at the start of treatment with
Orlistat has been studied in long-term clinical studies of
up to 4 years duration.
If you take more Orlistat than you should
If you take more capsules than you have been told to
take, or if someone else accidentally takes your medicine,
contact a doctor, pharmacist or hospital as you may need
medical attention.
If you forget to take Orlistat
If you forget to take your medicine at any time, take it as
soon as you remember provided this is within one hour of
your last meal, then continue to take it at the usual times.
Do not take a double dose. If you have missed several
doses, please inform your doctor and follow the advice
given to you. Do not change the prescribed dose yourself
unless your doctor tells you to.
If you have further questions on the use of this medicine,
ask your doctor or pharmacist.
If you stop taking Orlistat
If you have any further questions on the use of this
medicine, ask your doctor, or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor or pharmacist as soon as possible if you
do not feel well while you are taking Orlistat.
The majority of unwanted effects related to the use
of Orlistat result from its local action in your digestive
system. These symptoms are generally mild, occur at the
beginning of treatment and are particularly experienced
after meals containing high levels of fat. Normally, these
symptoms disappear if you continue treatment and keep
to your recommended diet.
Very common side effects (affects more than 1 user
in 10)
• Headache
• Abdominal pain/discomfort, urgent or increased need
to open the bowels, flatulence (wind) with discharge,
oily discharge, oily or fatty stools, liquid stools, low
blood sugar levels (experienced by some people with
type 2 diabetes).
Common side effects (affects 1 to 10 users in 100)
• Rectal pain/discomfort, soft stools, incontinence
(stools), bloating (experienced by some people with
type 2 diabetes)

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the national reporting system:
United Kingdom: Yellow Card Scheme.
Ireland: HPRA Pharmacovigilance; Earlsfort Terrace, IRL
- Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517,
Website: e-mail:
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Orlistat
Keep out of the sight and reach of children.
Do not use Orlistat after the expiry date stated on the
Do not store above 25°C.
Store in original package and keep the blister in the outer
carton in order to protect from light and moisture.
Medicines should not be disposed via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines no longer required. These measures will help
to protect the environment.
6. Contents of the pack
and other information
What Orlistat contains
• The active substance is orlistat. Each capsule contains
120 mg of orlistat.
• The other ingredients are microcrystalline cellulose
(E460), sodium starch glycolate (type A), colloidal
anhydrous silica and sodium laurilsulfate. The capsule
shell consists of gelatin, indigo carmine (E132) and
titanium dioxide (E171).
What Orlistat looks like and contents of the pack
Orlistat capsules are blue capsules and are supplied in
blister packs, containing 21, 42 and 84 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Alissa Healthcare Research Limited, Unit 5, Fulcrum
1, Solent Way, Whiteley, Fareham, Hampshire, United
Kingdom, PO15 7FE
Pharmaceutical Works POLPHARMA SA, 19 Pelplinska
Street, 83-200 Starogard Gdanski, Poland
This medicinal product is authorised in the Member
States of the EEA under the following names:

• Tooth/gum disorder

United Kingdom: Orlistat 120 mg Capsules, hard
Orlistat 120 mg Capsules, hard

• Irregularity of menstrual cycle

This leaflet was last revised in 05/2017

• Tiredness.
The following side effects have also been reported
but their frequency cannot be estimated from the
available data:
• Allergic reactions. The main symptoms are itching,
rash, wheals (slightly elevated, itchy skin patches
that are paler or redder than surrounding skin), severe
difficulty in breathing, nausea, vomiting and feeling
• Skin blistering (including blisters that burst)
• Diverticulitis
• Bleeding from the back passage (rectum)
• Increases in the levels of some liver enzymes may be
found in blood tests
• Hepatitis (inflammation of the liver). Symptoms can
include yellowing skin and eyes, itching, dark coloured
urine, stomach pain and liver tenderness (indicated by
pain under the front of the rib cage on your right hand
side), sometimes with loss of appetite. Stop Orlistat if
such symptoms occur and tell your doctor.
• Gallstones
• Pancreatitis (inflammation of the pancreas)
• Oxalate nephropathy (build up of calcium oxalate which
may lead to kidney stones). See Section 2, Warnings
and Precautions.
• Effects on clotting with anti-coagulants.
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