Xenical 120mg Capsules - Orlistat

Weight Loss Doctor Service

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 from being digested.

Xenical 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.

Xenical is indicated in the treatment of obesity in conjunction with a low calorie intake diet.

Children and adolescents Xenical is not intended to be used in children and adolescents below 18 years of age.

General Information

Xenical 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. Xenical only works in the presence of dietary fat. Therefore, if you miss a main meal or if you have a meal containing no fat, Xenical does not need to be taken.

Your doctor will discontinue the treatment with Xenical after 12 weeks if you have not lost at least 5% of
your body weight as measured at the start of treatment with Xenical.

Xenical has been studied in long-term clinical studies of up to 4 years duration.

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 Xenical.

The majority of unwanted effects related to the use of Xenical 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.

For a full list of side effects, please read the patient information leaflet.

Very common side effects (may affect more than 1 in 10 people):

• headache
• upper respiratory tract infection
• abdominal pain/discomfort
• urgent or increased need to open the bowels
• flatulence (wind)
• flatulence (wind) with discharge
• oily discharge
• oily or fatty stools
• liquid stools
• increased elimination of stools
• influenza (‘flu’)
• low blood sugar levels (experienced by some people with type 2 diabetes).

Common side effects (may affect up to 1 in 10 people):

• lower respiratory tract infection
• rectal pain/discomfort
• soft stools
• faecal incontinence (inability to control your bowel movements)
• bloating (experienced by some people with type 2 diabetes)
• tooth/gum disorder
• urinary tract infection
• irregularity of menstrual cycle
• tiredness
• anxiety

If you get any side effects, talk to your doctor, our Rightdose pharmacists or nurse. This includes any possible side effects not listed in this leaflet.

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

Before taking any medication, it is important to read the Patient Information Leaflet. You can find information leaflets for your medicines by typing them into the search bar at medicines.org, or by contacting us.

Patient Information Leaflet - Xenical 120mg Hard Capsules - Orlistat

Other medicines and Xenical

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.

Xenical may modify the activity of:

• acarbose. Xenical is not recommended for people taking acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
• anticoagulant drugs (e.g. warfarin). Your doctor may need to monitor your blood coagulation.
• cyclosporine (medicine dampening down the body’s immune system). Co-administration with Xenical is not recommended. However, if such use is unavoidable, 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 (medicine used for irregular heart beat). You may ask your doctor for advice.
• medicines to treat HIV.
• medicines for depression, psychiatric disorders or anxiousness.

Xenical 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. If a multivitamin supplement is recommended, you should take it at least two hours after the administration of Xenical or at bedtime.

Xenical 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 Xenical together with antiepileptic drugs.

Xenical should be used with caution in patients treated with antidepressants and antipsychotics (including lithium).

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 not recommended. You must not breastfeed 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 to drive a car or operate machinery.

This medicine contains less than 1 mmol sodium (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.

How to store Xenical

Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the packaging after “EXP”.  The expiry date refers to the last day of that month.
• 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 measures will help protect the environment.

How to take Xenical 120mg Hard Capsules

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of Xenical is one 120mg 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.

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 or hospital immediately 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 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 one. 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 any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Do not take Xenical:

• if you are allergic to orlistat or any of the other ingredients of this medicine
• if you have chronic malabsorption syndrome (insufficient absorption of nutrients across the gastrointestinal (GI) tract)
• if you have cholestasis (liver disorder)
• if you are breastfeeding.

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 Xenical 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 Xenical 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 Xenical 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

Xenical is not intended to be used in children and adolescents below 18 years.