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Orlistat (Xenical)

  • Weight-loss medicine
  • Blocks the absorption of fat from food
  • Take with food
  • Can cause diarrhoea with high-fat foods

About Orlistat

Orlistat 120 mg Teva 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.

How to take Orlistat

Always take Orlistat 120 mg Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Dosage:

  • Adults: one 120-mg capsule taken with each of the three main meals per day.

The capsule can be taken immediately before, during a meal or up to one hour after a meal. It should be swallowed with water.

If you take more or less Orlistat than you should

Always follow the prescription exactly – never take more or less than your doctor recommends. 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. If more time has passed, then skip the missed dose and continue with your regular dosing schedule. If you have missed several doses, please inform your doctor and follow the advice given to you.

If you take more capsules than you have been told to take, contact a doctor as you may need medical attention.

Instructions for use

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. 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 the treatment.

When not to use Orlistat

Orlistat is not suitable for everyone. Do not take Orlistat if:

  • You are allergic to any of the ingredients in this medicine (see section 'What Orlistat contains').
  • You have chronic malabsorption syndrome (insufficient absorption of nutrients from alimentary tract).
  • You have cholestasis (liver disorder).
  • You are breastfeeding.
  • Orlistat is not suitable for use in children.

When should Orlistat be used with caution?
Orlistat should be used with extreme caution in the following situations:

Weight loss may 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.

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.

Pregnancy and breastfeeding
Taking Orlistat during pregnancy is not recommended.

You must not breastfeed your infant during treatment with Orlistat. This is because it is not known if Orlistat passes into breast milk.

Other medicines and Orlistat

Some medicines and Orlistat may interact with each other. Orlistat may modify the activity of:

  • Acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus). Co-administration with acarbose is not recommended.
  • Anticoagulant drugs (e.g., warfarin). Your doctor may need to monitor your blood coagulation.
  • Ciclosporin. Co-administration with ciclosporin is not recommended. If co-administration is necessary, 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.

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.

For more warnings about the use of Orlistat, please see the package leaflet.

Side effects

Like all medicines, Orlistat can cause side effects, although not everyone 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 (may affect more than 1 in 10 users)

  • 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 (may affect up to 1 in 100 users)

  • Rectal pain/discomfort.
  • Soft stools.
  • Incontinence (stools).
  • Bloating (experienced by some people with type 2 diabetes).
  • Tooth/gum disorder.
  • Irregularity of menstrual cycle.
  • Tiredness.

For a list of less common side effects, please see the package leaflet. Consult a doctor if the side effects are severe or if you experience side effects that are not listed on the leaflet.

What Orlistat contains

What ingredients are in this medicine?

The active substance is orlistat. Each capsule contains 120 mg of orlistat.

The other ingredients are:

  • Capsule content: microcrystalline cellulose (E460), sodium starch glycolate (type A),
    silica hydrophobic colloidal, sodium lauryl sulphate.
  • Capsule shell: gelatine, indigo carmine (E132), titanium dioxide (E171).

The manufacturer of Orlistat is:

Pharmaceutical Works POLPHARMA SA
19 Pelplińska Street
83-200 Starogard Gdański
Poland

Package leaflet

Read the package leaflet before use. You can download the official package leaflet of Orlistat here.

Patient Leaflet(s)
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