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ORLISTAT 120 MG CAPSULES HARD

Active substance(s): ORLISTAT

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TEVA UK Ref:

231-30-13348-A LEA ORLISTAT 120mg CAP HARD MYLAN FrPOL
Dimensions:
Length:
Width:

500 mm
180 mm

Colours Used:

Orlistat 120 mg capsules,
hard
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Version:

4

20 June 2016
CUTTER
BLACK

Other medicines and Orlistat Capsules
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines. This is important as
using more than one medicine at the
same time can strengthen or weaken the
effects of the medicines.

Read all of this leaflet carefully before
you start taking this medicine because it
Orlistat Capsules may modify the
contains important information for you.
activity of:
− Keep this leaflet. You may need to read • anticoagulant drugs (e.g. warfarin).
it again.
Your doctor may need to monitor
− If you have any further questions, ask
your blood coagulation.
your doctor or your pharmacist.
• ciclosporin (medicine dampening
− This medicine has been prescribed for
down the body's immune system).
you only. Do not pass it on to others. It
Co-administration with Orlistat
may harm them, even if their signs of
Capsules is not recommended.
illness are the same as yours.
However, if such use is unavoidable,
− If you get any of the side effects, talk to
your doctor may need to monitor
your doctor or pharmacist. This
your ciclosporin blood levels more
includes any possible side effects not
frequently than usual.
listed in this leaflet. See section 4.
• iodine salts and/or levothyroxine.
Cases of hypothyroidism and/or
What is in this leaflet:
reduced control of hypothyroidism
1. What Orlistat 120 mg Capsules are and
may occur.
what they are used for
• amiodarone (medicine used for
2. What you need to know before you
irregular heart beat). You may ask
take Orlistat 120 mg Capsules
your doctor for advice.
3. How to take Orlistat 120 mg Capsules
• medicines to treat HIV.
4. Possible side effects
• medicines for depression, psychiatric
5. How to store Orlistat 120 mg Capsules
disorders or anxiousness.
6. Contents of the pack and other
Orlistat Capsules reduces the absorption
information
of supplements of some fat soluble
What
Orlistat
120
mg
Capsules
nutrients, particularly beta-carotene and
1
are and what they are used for
vitamin E. You should therefore follow
your doctor’s advice in taking a well
Orlistat Capsules is a medicine used to
balanced diet rich in fruit and vegetables
treat obesity. It works in your digestive
and in taking a multivitamin supplement.
system to block about one-third of the fat
in the food you eat from being digested. Orlistat may interfere with
anticonvulsant treatment by decreasing
Orlistat attaches to the enzymes in your the absorption of antiepileptic drugs,
digestive system (lipases) and blocks
thus leading to convulsions. Please
them from breaking down some of the
contact your doctor if you think that the
fat you have eaten during your meal. The frequency and/or severity of the
undigested fat cannot be absorbed and convulsions have changed when taking
is eliminated by your body.
Orlistat Capsules together with
Orlistat Capsules is indicated in the
antiepileptic drugs.
treatment of obesity in conjunction with Orlistat 120 mg Capsules is not
a low calorie intake diet.
recommended for people taking

2 What you need to know before
you take Orlistat 120 mg
Capsules

acarbose (an anti-diabetic drug used to
treat type 2 diabetes mellitus).

Orlistat 120 mg Capsules with food and
drink
Do not take Orlistat Capsules
Orlistat Capsules can be taken
• if you are allergic to orlistat or any of
immediately before, during a meal or up
the other ingredients of this medicine
to one hour after a meal. The capsule
(listed in section 6)
should be swallowed with water.
• if you have chronic malabsorption
syndrome (insufficient absorption of Pregnancy and breast-feeding
nutrients across the gastrointestinal Taking Orlistat Capsules during
pregnancy is not recommended.
(GI) tract)
• if you have cholestasis (liver disorder) You must not breast-feed your infant
during treatment with Orlistat Capsules
• if you are breast-feeding.
as it is not known whether Orlistat
Warnings and precautions
Capsules passes into human milk.
Talk to your doctor or pharmacist before
Driving and using machines
taking Orlistat Capsules.
Orlistat Capsules has no known effect on
Weight loss may also affect the dose of
your ability to drive a car or operate
medicines taken for other conditions
machinery.
(e.g. high cholesterol or diabetes). Be sure
to discuss these and other medicines you 3 How to take Orlistat 120 mg
may be taking with your doctor. Losing
Capsules
weight may mean you need adjustments
Always take this medicine exactly as your
to the dose of these medicines.
doctor has told you. Check with your
To gain the maximum benefit from
doctor or pharmacist if you are not sure.
Orlistat Capsules you should follow the
nutrition program recommended to you Dose:
The usual dose of Orlistat Capsules is
by your doctor. As with any
one 120 mg capsule taken with each of
weight-control program,
the three main meals per day. Orlistat
over-consumption of fat and calories
120 mg Capsules can be taken
may reduce any weight loss effect.
immediately before, during a meal or up
This medicine can cause harmless
to one hour after a meal. The capsule
changes in your bowel habits, such as
should be swallowed with water.
fatty or oily stools, due to the elimination
General information:
of undigested fat in your faeces. The
Orlistat Capsules should be taken with a
possibility of this happening may
increase if Orlistat Capsules is taken with well-balanced, calorie controlled diet
that is rich in fruit and vegetables and
a diet high in fat. In addition your daily
intake of fat should be distributed evenly contains an average of 30% of the
over three main meals because if Orlistat calories from fat. Your daily intake of fat,
Capsules is taken with a meal very high carbohydrate and protein should be
distributed over three meals. This means
in fat, the possibility of gastrointestinal
you will usually take one capsule at
effects may increase.
breakfast time, one capsule at lunch time
The use of an additional contraceptive
and one capsule at dinner time. To gain
method is recommended to prevent
optimal benefit, avoid the intake of food
possible failure of oral contraception that containing fat between meals, such as
could occur in cases of severe diarrhoea. biscuits, chocolate and savoury snacks.
The use of orlistat may be associated
Orlistat Capsules only works in the
with renal stones in patients suffering
presence of dietary fat. Therefore, if you
from chronic kidney disease. Inform your miss a main meal or if you have a meal
doctor if you suffer from problems with containing no fat, Orlistat Capsules does
your kidneys.
not need to be taken.
Tell your doctor if, for any reason, you
Children and adolescents
have not taken your medicine exactly as
Orlistat Capsules is not intended to be
used in children and adolescents below prescribed. Otherwise, your doctor may
think that it was not effective or well
18 years.

TEVA UK Ref:

231-30-13348-A LEA ORLISTAT 120mg CAP HARD MYLAN FrPOL
Dimensions:
Length:
Width:

500 mm
180 mm

Colours Used:

Orlistat Capsules has been studied in
long-term clinical studies of up to 4
years duration.
If you take more Orlistat Capsules 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
immediately as you may need medical
attention.

4

20 June 2016
CUTTER
BLACK

tolerated and may change your
treatment unnecessarily.
Your doctor will discontinue the
treatment with Orlistat Capsules after 12
weeks if you have not lost at least 5% of
your body weight as measured at the
start of treatment with Orlistat Capsules

Version:






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.
skin blistering (including blisters that
burst)
effects on clotting with
anti-coagulants
pancreatitis (inflammation of the
pancreas)
oxalate nephropathy (build up of
calcium oxalate which may lead to
kidney stones). See section 2,
Warnings and precautions.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. You can also report
If you forget to take Orlistat Capsules
If you forget to take your medicine at any side effects directly via the Yellow Card
Scheme at:
time, take it as soon as you remember
provided this is within one hour of your www.mhra.gov.uk/yellowcard
last meal, then continue to take it at the By reporting side effects you can help
provide more information on the safety
usual times. Do not take a double dose
of this medicine.
to make up for a forgotten one. If you
have missed several doses, please
How to store Orlistat 120 mg
inform your doctor and follow the advice 5 Capsules
given to you.
Do not change the prescribed dose
Keep out of the sight and reach of
yourself unless your doctor tells you to. children.
If you have further questions on the use Do not use this medicine after the expiry
of this medicine, ask your doctor or
date which is stated on the packaging
pharmacist.
after “EXP”.The expiry date refers to the
last day of that month.

4 Possible side effects

Like all medicines, this medicine can
cause side effects, although not
everybody gets them.

Do not store above 25ºC.
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
The majority of unwanted effects related measures will help protect the
environment.
to the use of Orlistat Capsules result
from its local action in your digestive
6 Contents of the pack and other
system. These symptoms are generally
information
mild, occur at the beginning of treatment
and are particularly experienced after
What Orlistat 120 mg Capsules contains
meals containing high levels of fat.
• The active substance is orlistat. Each
Normally, these symptoms disappear if
hard capsule contains 120 mg of
you continue treatment and keep to your
orlistat.
recommended diet.
• The other ingredients are:
capsule filling: microcrystalline
Very common side effects (these may
cellulose,
sodium starch glycolate
affect more than 1 in 10 patients)
(type
A),
silica
colloidal anhydrous,
• headache
sodium
laurilsulfate;
• upper respiratory tract infection
capsule shell: gelatin, titanium dioxide
• abdominal pain/discomfort
(E171), indigo carmine (E132).
• oily spotting from the rectum
• urgent or increased need to open the What Orlistat 120 mg Capsules looks like
bowels
and contents of the pack
• flatulence (wind) with discharge
Orlistat 120 mg Capsules are blue and
• oily discharge
are supplied in blister packs, containing
• oily or fatty stools
21, 42, 60, 84, 90 and 120 capsules.
• liquid stools
Not all pack sizes may be marketed.
• low blood sugar levels (experienced
Marketing Authorisation Holder and
by some people with type 2 diabetes)
Manufacturer
• flu infection.
Marketing Authorisation Holder: Teva UK
Common side effects (these may affect
Limited, Eastbourne, BN22 9AG, United
up to 1 in 10 patients)
Kingdom
• lower respiratory tract infection
Manufacturer: Pharmaceutical Works
• rectal pain/discomfort
Polpharma SA, 19, Pelplińska Street,
• soft stools
83-200 Starogard Gdański, Poland
• incontinence (stools)
This leaflet was last revised in December
• bloating (experienced by some
2015
people with type 2 diabetes)
• tooth/gum disorder
PL 00289/1680
• urinary tract infection
• irregularity of menstrual cycle
• tiredness
• anxiety.
Tell your doctor or pharmacist as soon
as possible if you do not feel well while
you are taking Orlistat Capsules.

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 unwell. Contact your doctor
immediately if you experience any of
these.
• bleeding from the back passage
(rectum).
• increases in the levels of some liver
enzymes may be found in blood tests
• diverticulitis (the most common
symptom is abdominal pain.
Cramping, nausea, vomiting, fever,
chills, or a change in bowel habits
may also appear).
• gallstones
• hepatitis (inflammation of the liver).
Symptoms can include yellowing
skin and eyes, itching, dark coloured

13348-A

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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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