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ORLISTAT 120 MG HARD CAPSULES

Active substance(s): ORLISTAT / ORLISTAT / ORLISTAT

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Orlistat 120 mg Capsules PIL - UK

Review - 9
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This is important as using more than one medicine
at the same time can strengthen or weaken the
effects of the medicines.
Package leaflet: Information for the user

Orlistat 120mg hard capsules
orlistat

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 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 of the 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
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 to orlistat or any of the other
ingredients of this medicine (listed in section 6)
- if you have chronic malabsorption syndrome
(insufficient absorption of nutrients from
alimentary tract)
- if you have cholestasis (liver disorder)
- if you are breast-feeding (see “Pregnancy and
breast-feeding”).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Orlistat.
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 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
diarrhoea.
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 kidney.
Children
Orlistat is not intended to be used in children.
Other medicines and Orlistat
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Size: 150 x 400 mm, Pantone: Black, Font Size: 9 pt
Date: 06/01/17

Orlistat may modify the activity of:
− Anticoagulant (medicine used to thin blood, e.g.
warfarin). Your doctor may need to monitor your
blood coagulation.
− Ciclosporin (medicine dampening down the
body’s immune system). Co-administration with
ciclosporin is not recommended. Your doctor
may need to monitor your ciclosporin blood
levels more frequently than usual.
− Iodine salts and/or levothyroxine (medicines
used to treat thyroid gland problems). Cases of
hypothyroidism (condition when thyroid gland
does not produce enough hormones) and/or
reduced control of hypothyroidism may occur.
− Amiodarone (medicine used for irregular heart
beat). You may ask your doctor for advice.
− Medicines to treat HIV.
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 anticonvulsant
(antiepileptic) treatment, by decreasing the
absorption of antiepileptic medicines, thus leading to
convulsions. Please contact your doctor if you think
that the frequency and/or severity of the convulsions
(fits) have changed when taking Orlistat together
with antiepileptic medicines.
Orlistat is not recommended for people taking
acarbose (an anti-diabetic medicine used to treat
type 2 diabetes mellitus).
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
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
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 (see “Do not take Orlistat”).
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 this medicine exactly as your doctor has
told you. 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 does not need to 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.
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.
Orlistat has been studied in long-term clinical
studies of up to 4 years duration.

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Orlistat 120 mg Capsules PIL - UK
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.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Orlistat and see a doctor straight away, if
you notice any of the following serious side effects:
- 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 unwell.
- 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.
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.
Other Side effects:

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5. How to store Orlistat

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Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is stated on the carton. The expiry date refers to the
last day of that month.
Do not store above 25°C. Store in the original
package in order to protect from light and moisture.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

6. Contents of the pack and other
information
What Orlistat contains
- The active substance is orlistat. Each hard
capsule contains 120 mg of orlistat.
- The other ingredients are cellulose,
microcrystalline PH 112, sodium starch
glycolate (type A), silica, colloidal anhydrous
and sodium laurilsulfate. The capsule shell
consists of gelatine, titanium dioxide (E171)
and indigo carmine (E132).
What Orlistat looks like and contents of the pack
Orlistat capsules are hard gelatin, blue capsules:
content is white powder or slightly compacted
agglomerates: size of capsules No.1 and are
supplied in blister pack, containing 21, 42 and 84
capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Ltd
70 Sir John Rogerson’s Quay,
Dublin 2
Ireland
Manufacturer
Pharmaceutical Works POLPHARMA S.A.
19 Pelplińska Street, Starogard Gdański
83-200 Poland
This leaflet was last revised in January-2017.

Very common (may affect more than 1 in 10 people):
- headache
- abdominal pain/discomfort
- urgent or increased need to open the bowels
- flatulence (wind) with or without discharge
- oily discharge, oily or fatty stools
- liquid stools
- low blood sugar levels (experienced by some
people with type 2 diabetes)
- upper respiratory infections - which affect the
nose, sinuses and throat
- flu (influenza)
Common (may affect up to 1 in 10 people):
- rectal pain/discomfort
- soft stools
- incontinence (stools)
- bloating (experienced by some people with type
2 diabetes)
- tooth/gum disorder
- irregularity of menstrual cycle
- tiredness
- anxiety
- lower respiratory infections - which affect the
airways and lungs
- urinary tract infections
Not known (frequency cannot be estimated from
the available data):
- skin blistering (including blisters that burst)
- diverticulitis (inflammation of small
outpouchings along the wall of the colon)
- bleeding from the back passage (rectum)
- increases in the levels of some liver enzymes
may be found in blood tests
- 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.
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 MHRA Yellow Card Scheme –
Website: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on
the safety of this medicine.

Size: 150 x 400 mm, Pantone: Black, Font Size: 9 pt
Date: 06/01/17

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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