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ORLISTAT 120 MG HARD CAPSULES

Active substance(s): ORLISTAT

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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.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have
told you.

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 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.

You must talk to your doctor or pharmacist if you do not lose weight after taking Orlistat for 12
weeks. You may need to stop taking Orlistat.

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.
You must talk to a doctor or pharmacist if you do not lose weight after taking Orlistat for 12 weeks.
You may need to stop taking Orlistat.

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 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.

Take special care with ORLISTAT (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 and Adolescents
Orlistat is not intended to be used in children or adolescents.
Other medicines and Orlistat
Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 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.
• Iodine salts and/or levothyroxine. Cases of hypothyroidism and/or reduced control of
hypothyroidism may occur.
• Amiodarone. 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 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 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, breast-feeding and fertility
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.
Studies do not indicate harmful effects with respect to fertility.

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 described in this leaflet or as your doctor or pharmacist have 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 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.
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.
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 to make up for a forgotten 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)
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.
• 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 Chapter 2, take special care wih Orlistat.
• 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 national reporting system
listed in https://yellowcard.mhra.gov.uk/.
By reporting side effects you can help provide more information on the safety of this medicine.

5.

HOW TO STORE ORLISTAT

Keep this medicine out of the sight and reach of children.
Blister packs
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 capsule contains 120 mg of orlistat.
The other ingredients are microcrystalline cellulose (E460), sodium starch glycolate (type A),
sodium laurilsulfate, Silica, colloidal anhydrous. The capsule shell consists of gelatine, indigo
carmine (E132) and titanium dioxide (E171).

What ORLISTAT looks like and contents of the pack
Orlistat capsules are blue and are available in blister packs containing 21, 42, 60 and 84 capsules. Not
all pack sizes may be marketed.
Marketing Authorisation Holder
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton, Hants, RG25 3ED

This leaflet was last revised in 08/2015
Detailed information on this medicine is available on the Medicines and Healthcare products
Regulatory Agency (MHRA) web site: http://www.mhra.gov.uk/

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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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