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PACKAGE LEAFLET:INFORMATION FOR THE USER

Xenical® 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 itagain.
• If you have any further questions, please ask
your doctor or your 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 sameas 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 Xenical is and what it is used for
2. What you need to know before you take
Xenical3. How to take Xenical
4. Possible side effects
5. How to store Xenical
6. Contents of the pack and other information1. What XENICAL is and what it isused for
Xenical 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 frombeing digested.
Xenical attaches to the enzymes in yourdigestive system (lipases) and blocks them frombreaking down some of the fat you have eaten
during your meal. The undigested fat cannot beabsorbed and is eliminated by your body.
Xenical is indicated in the treatment of obesity
in conjunction with a low calorie intake diet.

2. What you need to know before you
take XENICAL
Do not take XENICAL• if you are allergic (hypersensitive) to orlistat or
to any of the other ingredients of Xenical,• if you have chronic malabsorption syndrome(insufficient absorption of nutrients fromalimentary tract),• if you have cholestasis (liver disorder)• if you are breast-feeding
Warnings and precautions
Weight loss may also affect the dose ofmedicines taken for other conditions (e.g. highcholesterol or diabetes). Be sure to discuss theseand other medicines you may be taking withyour doctor. Losing weight may mean you needadjustments to the dose of these medicines.
To gain the maximum benefit from Xenicalyou should follow the nutrition program

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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 inyour bowel habits, such as fatty or oily stools,
due to the elimination of undigested fat in yourfaeces. The possibility of this happening may
increase if Xenical is taken with a diet high infat. In addition your daily intake of fat should
be distributed evenly over three main meals
because if Xenical is taken with a meal very highin fat, the possibility of gastrointestinal effects
may increase.
The use of an additional contraceptive method isrecommended to prevent possible failure of oral
contraception that could occur in case of severe
diarrhoea.
The use of orlistat may be associated with renalstones in patients suffering from chronic kidneydisease. Inform your doctor whether you sufferfrom problems with your kidney.
This medicine contains less than 1 mmol sodium(23 mg) per capsule, that is to say essentially`sodium-free‘.
Children
Xenical is not intended to be used in children.
Other medicines and Xenical
Please inform your doctor or pharmacist if you
are taking or have recently taken any othermedicines, 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.
Xenical may modify the activity of• Anticoagulant drugs (e.g. warfarin). Your
doctor may need to monitor your bloodcoagulation.

• Ciclosporin. Co-administration withciclosporin is not recommended. Your doctor
may need to monitor your ciclosporin bloodlevels more frequently than usual.
• Iodine salts and/or levothyroxine. Cases ofhypothyroidism and/or reduced control ofhypothyroidism may occur.
• Amiodarone. You may ask your doctor foradvice.
• Medicines to treat HIV.

• Medicines for depression, psychiatric disorders
or anxiousness
Xenical reduces the absorption of supplementsof some fat soluble nutrients, particularly betacarotene and vitamin E. You should therefore
follow your doctor’s advice in taking a wellbalanced diet rich in fruit and vegetables.
Your doctor may suggest you take amultivitamin supplement.
Orlistat may unbalance an anticonvulsant
treatment, by decreasing the absorption ofantiepileptic drugs, thus leading to convulsions.
Please contact your doctor if you think that thefrequency and/or severity of the convulsions
have changed when taking Xenical together with
antiepileptic drugs.

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Xenical is not recommended for people taking
acarbose (an anti-diabetic drug used to treat type2 diabetes mellitus).
Xenical with food and drink
Xenical 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 Xenical during pregnancy is notrecommended.
You must not breast-feed your infant during
treatment with Xenical as it is not known
whether Xenical passes into human milk.
Driving and using machines
Xenical has no known effect on your ability todrive a car or operate machinery.

3. How to take XENICAL
Always take Xenical exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure. The usual doseof Xenical is one 120 mg capsule taken witheach of the three main meals per day. It can betaken immediately before, during a meal or up
to one hour after a meal. The capsule should beswallowed with water.
Xenical should be taken with a well-balanced,
calorie controlled diet that is rich in fruit andvegetables 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 usuallytake one capsule at breakfast time, one capsule
at lunch time and one capsule at dinner time. To
gain optimal benefit, avoid the intake of foodcontaining fat between meals, such as biscuits,
chocolate and savoury snacks.
Xenical only works in the presence of dietaryfat. Therefore, if you miss a main meal or if you
have a meal containing no fat, Xenical need not
be taken.
Tell your doctor if, for any reason, you have nottaken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was noteffective or well tolerated and may change yourtreatment unnecessarily.
Your doctor will discontinue the treatment with
Xenical after 12 weeks if you have not lost atleast 5 % of your body weight as measured at thestart of treatment with Xenical.
Xenical has been studied in long-term clinicalstudies of up to 4 years duration.
If you take more XENICAL 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 orhospital as you may need medical attention.
If you forget to take XENICAL
If you forget to take your medicine at any time,
take it as soon as you remember provided this iswithin 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 thismedicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Xenical can cause sideeffects, although not everybody gets them.
Tell your doctor or pharmacist as soon as
possible if you do not feel well while you aretaking Xenical.
The majority of unwanted effects related to theuse of Xenical result from its local action in yourdigestive system. These symptoms are generally
mild, occur at the beginning of treatment and areparticularly experienced after meals containing
high levels of fat. Normally, these symptoms
disappear if you continue treatment and keep toyour 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), tooth/gum disorder,
irregularity of menstrual cycle, tiredness.
The following side effects have also beenreported but their frequency cannot be estimatedfrom the available data:
Allergic reactions. The main symptoms areitching, rash, wheals (slightly elevated, itchyskin patches that are paler or redder thansurrounding skin), severe difficulty in breathing,nausea, vomiting and feeling unwell. Skinblistering (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 Xenical 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 Chapter 2, take special care with Xenical.
Effects on clotting with anti-coagulants.
Reporting of side effects
If you get any side effects, talk to your doctor

DRAFT(DATE) 06.01.2022 [12:00 uhr] (1)COLOURS Pantone Black linework
DIMENSIONS 150 + 150 x 304,5 mm
MATERIAL NUMBER 90005467/11
FONT SIZE 9 pt
PRODUCT CODE DP 86068755 GB-CPor pharmacist. This includes any possible sideeffects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard or
search for MHRA Yellow Card in the Google
Play or Apple App Store.
By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store XENICAL
Keep out of the sight and reach of children
Blister packs
Do not use Xenical after the expiry date statedon the carton.
Do not store above 25 °C.
Store in original package and keep the blister inthe outer carton in order to protect from light andmoisture.
Glass bottles
Do not use Xenical after the expiry date statedon the bottle.
Do not store above 30 °C.
Keep container tightly closed in order to protectfrom moisture.
Medicines should not be disposed via
wastewater or household waste. Ask yourpharmacist how to dispose of medicines nolonger required. These measures will help toprotect the environment.

6. Contents of the pack and otherinformation
What XENICAL contains• The active substance is orlistat. Each capsulecontains 120 mg of orlistat.
• The other ingredients are microcrystalline
cellulose (E460), sodium starch glycolate (typeA), povidone (E1201), sodium laurilsulfate
and talc. The capsule shell consists of gelatine,indigo carmine (E132), titanium dioxide(E171) and edible printing ink.
What XENICAL looks like and contents ofthe pack
Xenical capsules are turquoise with the imprint“XENICAL 120” and are supplied in blister
packs and glass bottles, containing 21, 42 and84 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Neon Healthcare Ltd.
8 The Chase, John Tate Road
Hertford, SG13 7NN
United Kingdom
Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 23-24
17489 Greifswald
GermanyThis leaflet was last revised in January 2022.

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DRAFT(DATE) 06.01.2022 [12:00 uhr] (1)COLOURS Pantone Black linework
DIMENSIONS 150 + 150 x 304,5 mm
MATERIAL NUMBER 90005467/11
FONT SIZE 9 pt
PRODUCT CODE DP 86068755 GB-CP

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