ORLISTAT 120 MG CAPSULES HARD

Active substance: ORLISTAT

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231-30-13312-E LEA ORLISTAT 120mg CAP HARD TUK FrPOL

Version:

1

20 June 2012

PL Number(s),
PL 00289/1680. Polpharma Licence (Responsible Regulatory Officer = Yogesh Toraskar),
MA Holder & Packer: Packed at Polfarma Limited.
Reason for revision: Trackwise record 137499, child of 137498: Update of Risk Management Plan.

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Date: 2012.06.21
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180 mm

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Final approval by MA Holder confirming receipt of MHRA/IMB
approval; Sign & Date:

Pharma Code:
29 (1110) or 22 (0111)
depending on read direction.
3rd Party Code: UORL-C364-020
but may update.

Colours:

(PANTONE® is a registered
trademark of Pantone, Inc.)

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Approved by Alicja
Sadowska on
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Digitally signed by Yogesh
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UK, ou=Regulatory Affairs,
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toraskar@tevauk.com,
c=GB
Date: 2012.06.25 10:13:18
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UORL-C364-020

ORLISTAT 120 mg CAPSULES,
HARD
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Read all of this leaflet carefully before
you start taking this medicine.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions,
please ask your doctor or your
pharmacist.
• This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

Use in paediatric population (children
and adolescents below 18 years)
Orlistat Capsules is not intended to be
used in children and adolescents below
18 years.
Taking other medicines
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 medicines.

Orlistat Capsules may modify the activity of:
• anticoagulant drugs (e.g. warfarin).
Your doctor may need to monitor your
blood coagulation
• ciclosporin (medicine dampening down
the body's immune system).
Co-administration with Orlistat
IN THIS LEAFLET:
Capsules is not recommended.
However, if such use is unavoidable,
1. What Orlistat 120 mg Capsules
your doctor may need to monitor your
are and what they are used for
ciclosporin blood levels more
2. Before you take Orlistat 120 mg
frequently than usual
Capsules
• iodine salts and/or levothyroxine.
3. How to take Orlistat 120 mg Capsules
Cases of hypothyroidism and/or
4. Possible side effects
5. How to store Orlistat 120 mg Capsules reduced control of hypothyroidism may
occur
6. Further information
• amiodarone (medicine used for
irregular heart beat). You may ask your
1 WHAT ORLISTAT 120 mg
doctor for advice.
CAPSULES ARE AND WHAT
THEY ARE USED FOR
Orlistat Capsules reduces the absorption
of supplements of some fat soluble
Orlistat Capsules is a medicine used to
nutrients, particularly beta-carotene and
treat obesity. It works in your digestive
vitamin E. You should therefore follow
system to block about one-third of the fat
your doctor’s advice in taking a well
in the food you eat from being digested.
balanced diet rich in fruit and vegetables
and in taking a multivitamin supplement.
Orlistat attaches to the enzymes in your
digestive system (lipases) and blocks
Orlistat may unbalance an
them from breaking down some of the
anticonvulsivant treatment, by
fat you have eaten during your meal. The
decreasing the absorption of
undigested fat cannot be absorbed and
antiepileptic drugs, thus leading to
is eliminated by your body.
convulsions. Please contact your doctor
if you think that the frequency and/or
Orlistat Capsules is indicated in the
severity of the convulsions have changed
treatment of obesity in conjunction with
when taking Orlistat Capsules together
a low calorie intake diet.
with antiepileptic drugs.

2 BEFORE YOU TAKE ORLISTAT
120 mg CAPSULES
Do not take Orlistat Capsules
• if you are allergic (hypersensitive) to
orlistat or any of the other ingredients
of Orlistat Capsules
• if you have chronic malabsorption
syndrome (insufficient absorption of
nutrients across the gastrointestinal
(GI) tract)
• if you have cholestasis (liver disorder)
• if you are breast-feeding.
Take special care with Orlistat Capsules
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 Capsules 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 Capsules 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
Capsules is taken with a meal very high
in fat, the possibility of gastrointestinal
effects may increase.

Orlistat 120 mg Capsules is not
recommended for people taking
acarbose (an anti-diabetic drug used to
treat type 2 diabetes mellitus).
Taking Orlistat 120 mg Capsules with
food and drink
Orlistat Capsules 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 Capsules during
pregnancy is not recommended.
You must not breast-feed your infant
during treatment with Orlistat Capsules
as it is not known whether Orlistat
Capsules passes into human milk.
Driving and using machines
Orlistat Capsules has no known effect on
your ability to drive a car or operate
machinery.

3 HOW TO TAKE ORLISTAT 120 mg
CAPSULES
Always take Orlistat Capsules exactly as
your doctor has told you. You should
check with your doctor or pharmacist if
you are not sure.
Dose:
The usual dose of Orlistat Capsules is
one 120 mg capsule taken with each of
the three main meals per day. Orlistat
120 mg Capsules can be taken
immediately before, during a meal or up
to one hour after a meal. The capsule
should be swallowed with water.

General information:
Orlistat Capsules should be taken with a
well-balanced, calorie controlled diet
The use of an additional contraceptive
that is rich in fruit and vegetables and
method is recommended to prevent
contains an average of 30% of the
possible failure of oral contraception that
calories from fat. Your daily intake of fat,
could occur in cases of severe diarrhoea.
carbohydrate and protein should be
distributed over three meals. This means
The use of orlistat may be associated
you will usually take one capsule at
with renal stones in patients suffering
breakfast time, one capsule at lunch time
from chronic kidney disease. Inform your
and one capsule at dinner time. To gain
doctor whether you suffer from
optimal benefit, avoid the intake of food
problems with your kidney.
containing fat between meals, such as
biscuits, chocolate and savoury snacks.

Ref:

231-30-13312-E LEA ORLISTAT 120mg CAP HARD TUK FrPOL

Version:

1

20 June 2012

PL Number(s),
PL 00289/1680. Polpharma Licence (Responsible Regulatory Officer = Yogesh Toraskar),
MA Holder & Packer: Packed at Polfarma Limited.
Reason for revision: Trackwise record 137499, child of 137498: Update of Risk Management Plan.

Artwork Originator;
Sign & Date:

Digitally signed by
Stephen Lloyd
DN: cn=Stephen Lloyd,
o=Teva UK Ltd,
ou=Artwork
Origination,
email=stephen.lloyd@t
evauk.com, c=GB
Date: 2012.06.21
09:08:33 Z

Artwork Checker;
Sign & Date:

Approved for Regulatory submission into MHRA/IMB;
Sign & Date:

Sarah
Ferguson

Dimensions:
Fonts: Univers

L:
W:

Final approval by MA Holder confirming receipt of MHRA/IMB
approval; Sign & Date:

Packing Site Approval (where not TEVA UK Limited)
Sign & Date:

Digitally signed by Sarah Ferguson
DN: cn=Sarah Ferguson, o=Teva UK
Ltd, ou=Senior Artwork Originator,
email=sarah.ferguson@tevauk.com,
c=GB
Date: 2012.06.21 09:05:13 Z

500 mm
180 mm

Base Font Size: 11.5Pt

Pharma Code:
29 (1110) or 22 (0111)
depending on read direction.
3rd Party Code: UORL-C364-020
but may update.

Colours:

(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN
BLACK

IMPORTANT: Artwork, text and content must not be reset, remade, amended or
altered. The only exceptions to this are: bleeds, chokes, spreads or other print
related adjustments required for reproduction by the supplier. We must receive a
copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

• diverticulitis (the most common
Orlistat Capsules only works in the
symptom is abdominal pain. Cramping,
presence of dietary fat. Therefore, if you
nausea, vomiting, fever, chills, or a
miss a main meal or if you have a meal
change in bowel habits may also
containing no fat, Orlistat Capsules does
appear)
not need to be taken.
• gallstones
Tell your doctor if, for any reason, you
have not taken your medicine exactly as • hepatitis (inflammation of the liver).
Symptoms can include yellowing skin
prescribed. Otherwise, your doctor may
and eyes, itching, dark coloured urine,
think that it was not effective or well
stomach pain and liver tenderness
tolerated and may change your
(indicated by pain under the front of
treatment unnecessarily.
the rib cage on your right hand side),
sometimes with loss of appetite
Your doctor will discontinue the
• skin blistering (including blisters that
treatment with Orlistat Capsules after 12
burst)
weeks if you have not lost at least 5% of
• effects on clotting with anti-coagulants
your body weight as measured at the
start of treatment with Orlistat Capsules • pancreatitis (inflammation of the
pancreas)
• oxalate nephropathy (build up of
Orlistat Capsules has been studied in
calcium oxalate which may lead to
long-term clinical studies of up to 4
kidney stones). See Chapter 2, take
years duration.
special care with Orlistat 120 mg
Capsules).
If you take more Orlistat Capsules than
you should
If you take more capsules than you have If any of the side effects gets serious, or
if you notice any side effects not listed in
been told to take, or if someone else
accidentally takes your medicine, contact this leaflet, please tell your doctor or
pharmacist.
a doctor, pharmacist or hospital
immediately as you may need medical
attention.
5 HOW TO STORE ORLISTAT 120 mg
CAPSULES
If you forget to take Orlistat Capsules
If you forget to take your medicine at any Keep out of the reach and sight of
children.
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 Do not use Orlistat 120 mg Capsules
after the expiry date which is stated on
usual times. Do not take a double dose
the packaging after “EXP” The expiry
.
to make up for a forgotten one. If you
date refers to the last day of that month.
have missed several doses, please
inform your doctor and follow the advice
Do not store above 25ºC.
given to you.
Store in the original package in order to
Do not change the prescribed dose
yourself unless your doctor tells you to. protect from light and moisture.
If you have further questions on the use
of this product, ask your doctor or
pharmacist.

4 POSSIBLE SIDE EFFECTS
Like all medicines, Orlistat 120 mg
Capsules can cause side effects,
although not everybody gets them.

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 FURTHER INFORMATION

What Orlistat 120 mg Capsules contains
• The active substance is orlistat. Each
Tell your doctor or pharmacist as soon
hard capsule contains 120 mg of
as possible if you do not feel well while
orlistat.
you are taking Orlistat Capsules.
• The other ingredients are:
capsule filling: microcrystalline
The majority of unwanted effects related
cellulose, sodium starch glycolate (type
to the use of Orlistat Capsules result
A), sillica colloidal anhydrous, sodium
from its local action in your digestive
laurilsulfate;
system. These symptoms are generally
mild, occur at the beginning of treatment capsule shell: gelatin, titanium dioxide
(E171), indigo carmine (E132).
and are particularly experienced after
meals containing high levels of fat.
Normally, these symptoms disappear if What Orlistat 120 mg Capsules looks like
you continue treatment and keep to your and contents of the pack
Orlistat 120 mg Capsules are blue and
recommended diet.
are supplied in blister packs, containing
21, 42, 60, 84, 90 and 120 capsules.
Very common side effects (these may
Not all pack sizes may be marketed.
affect more than 1 in 10 patients)
• headache
Marketing Authorisation holder and
• abdominal pain/discomfort
Manufacturer
• urgent or increased need to open the
bowels
Marketing Authorisation holder:
• flatulence (wind) with discharge
• oily discharge
TEVA UK Limited, Eastbourne, BN22 9AG,
• oily or fatty stools
United Kingdom.
• liquid stools
• low blood sugar levels (experienced by Manufacturer:
some people with type 2 diabetes).
Pharmaceutical Works Polpharma SA, 19,
Pelplińska Street, 83-200 Starogard
Common side effects (these may affect
Gdański, Poland.
up to 1 in 10 patients)
• rectal pain/discomfort
This leaflet was last revised in May 2012.
• soft stools
• incontinence (stools)
• bloating (experienced by some people PL 00289/1680
with type 2 diabetes)
• tooth/gum disorder
• irregularity of menstrual cycle
• 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 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
13312-E

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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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