Patient leaflet - Orlistat 120 mg hard capsules
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 (hypersensitive) to orlistat or to any of the other ingredients of Orlistat
- have chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract)
- have cholestasis (liver disorder)
- are breast-feeding.
Warnings and precautions
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.
Orlistat contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1mmol sodium (23mg) per capsule, that is to say essentially ‘sodium-free’.
Children
Orlistat is not intended to be used in children.
Other medicines and Orlistat
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 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
- medicines for depression, psychiatric disorders or anxiousness.
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 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 and breast-feeding
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.
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 Orlistat exactly as your doctor has told you. You should 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. 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.
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 (affect more than 1 patient 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 (affect 1 to 10 patients 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 Section 2 “Warnings and precautions”
- effects on clotting with anti-coagulants.
Package leaflet: Information for the patient Orlistat 120 mg hard capsules
Front Side
(6029851) Date : 29/03/2024, (R) 06.03.2026 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 side effects directly via the Yellow Card Scheme Website 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 Orlistat
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
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 cellulose microcrystalline, lactose monohydrate, povidone , sodium laurilsulfate and talc. The capsule shell consists of gelatin, titanium dioxide (E171), Indigo carmine (E132) and printing ink [black iron oxide (E172), potassium hydroxide (E525), shellac (E904) and propylene glycol].
What Orlistat looks like and contents of the pack
Orlistat capsules are hard gelatin capsules (19.3 mm in diameter) with a turquoise cap and body bearing the imprint of "LO1" in black ink and contain white to off white powder or slightly compacted agglomerate.
Orlistat capsules are supplied in PVC/PE/PVdC-alu blister packs containing 42 or 84 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord, Barnstaple, EX32 8NS, UK
Manufacturers
Accord-UK Ltd
Whiddon Valley
Barnstaple
Devon
EX32 8NS
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex
HA1 4HF, United Kingdom
Accord Healthcare Single Member S.A.
64th Km National Road Athens, Lamia,
Schimatari, 32009, Greece
This leaflet was last revised in March 2026
If you would like a leaflet with larger text, please contact
01271 385257
Back Side
INP113 10 7330 0 6029851
(6029851) Date : 29/03/2024, (R) 06.03.2026