Xenical. 120 mg .42 capsules

 

XENICAL WHAT IS AND WHAT IT IS USED

Xenical is a drug used to treat obesity. It works in your digestive system by blocking the absorption of about one-third of the fat in the food you eat.

Xenical attaches to the enzymes in your digestive system (lipases) and blocks them by preventing degradation of some of the fat you take with food. Unabsorbed fat can not be absorbed and is eliminated from the body. Xenical is indicated for the treatment of obesity in conjunction with a diet low calorie intake.

 

 BEFORE YOU TAKE XENICAL

 

Do not take Xenical

 

If you are allergic (hypersensitive) to orlistat or any of the other ingredients of Xenical,

 If you have a chronic malabsorption (inadequate absorption of nutrients from the digestive system)

If you have cholestasis (liver disorder)

 If you are breastfeeding.

 

Take special care with Xenical

 

Losing weight can also affect the dose of medicines taken for other conditions (eg, high cholesterol or diabetes). Be sure to discuss this with your doctor and other medications you may be taking. Losing weight may mean that it is necessary to adjust the dose of these medications.

 

To gain the maximum benefit from treatment with Xenical, you should follow a diet that has been prescribed by your doctor. As with other programs for weight control, excessive use of fats and calories can reduce the effect of weight loss.

This medicine can cause harmless changes in your bowel habits, such as oily stools, due to the elimination of undigested fat in them. The likelihood of this may increase if Xenical is taken with a high fat meal. Moreover, the 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 likelihood of gastrointestinal effects may increase.

 

It is recommended to use an additional method of birth control to prevent possible failure of contraceptive administered orally, which could occur with severe diarrhea. The use of orlistat may be associated with kidney stones in patients suffering from chronic kidney disease. Tell your doctor if you have kidney problems.

 

Use in children

 

Xenical is indicated for use in children.

 

Taking other medicines

 

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

This is important as using more than one drug at the same time can strengthen or weaken the effects of the drugs.

 

Xenical may modify the activity of

 

 Anticoagulant drugs (eg warfarin). It may be necessary for your doctor to monitor blood coagulation.

 Cyclosporine. Co-administration with cyclosporine is not recommended. It may be necessary for your doctor to monitor the levels of cyclosporine in your blood more often than usual.

 Iodine salts and / or levothyroxine. There may be cases of hypothyroidism and / or reduced control of hypothyroidism.

 Amiodarone. You should consult your doctor.

Xenical reduces the absorption of some nutrients, soluble in fats, particularly beta-carotene and vitamin E. You should therefore follow your doctor's advice and follow a well-balanced diet rich in fruits and vegetables. Your doctor may advise you to take a multivitamin supplement.

 

Orlistat may unbalance anticonvulsant therapy by reducing absorption of antiepileptic drugs, which can lead to seizures. Please contact your doctor if you think that the frequency and / or severity of seizures changed when taking Xenical together with antiepileptic drugs.

 

Pregnancy and lactation

 

Not recommended intake of Xenical during pregnancy.

You should not breast-feed your baby during treatment with Xenical, because it is not known whether Xenical passes into breast milk in humans.

 

Driving and operating machinery

 

Xenical is not known to affect ability to drive or operate machinery.

 

 HOW TO TAKE XENICAL

 

Always take Xenical exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist. The usual dose of Xenical is one 120 mg capsule taken with each of the three main meals of the day. It can be taken immediately before, during meals or one hour after a meal. The capsule should be swallowed with water. 

Xenical should be taken with a well balanced calorie controlled diet that is rich in fruits and vegetables and contains an average of 30 percent of calories from fat. Your daily intake of fat, carbohydrate and protein should be distributed over three main meals. This means that should normally take one capsule at breakfast time, one capsule at lunch time and one capsule with dinner. To achieve maximum effect, between meals, avoid intake of foods containing fat such as biscuits, chocolate and savory snacks.

 

Xenical only works in the presence of dietary fat. Therefore, if you miss a main meal or meal that contains no fat, do not need to take Xenical.

Tell your doctor if for some reason you have not taken your medicine exactly as prescribed. Otherwise, the doctor gets the impression that the drug is not effective or well tolerated and may change your treatment unnecessarily.

Your doctor will stop your treatment with Xenical after 12 weeks if you have not lost their weight by at least 5% compared with the beginning of treatment with Xenical.

Xenical has been studied in clinical trials lasting up to four years. 

If you take more than the dose of Xenical 

If you take more capsules than you, or if someone else accidentally takes your medicine, contact your doctor, pharmacist or hospital as you may need medical attention. 

If you forget to take Xenical 

If you forget to take your medicine, take it as soon as you remember, unless it is more than one hour of your last meal, then continue to take it at the usual time. Do not take a double dose. If you have missed several doses, please inform your doctor and follow his instructions.

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 or pharmacist.

 

 POSSIBLE SIDE EFFECTS

 

Like all medicines, Xenical 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 taking Xenical.

Most of the side effects associated with the use of Xenical, the result of local action in your digestive system. These symptoms are usually mild and occur mostly after a meal high in fat. Usually these symptoms disappear if you continue treatment and keep to your recommended diet.

 Very common side effects (affects more than 1 in 10 people) 

Headache, abdominal pain / discomfort, urgent or increased need to open the bowels, flatulence (wind) with discharge, separation of fat, greasy 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 of stool, bloating (experienced by some people with type 2 diabetes), problems with teeth / gums, irregular menstrual cycle fatigue. 

Cases of the following side effects, but the existing data can not estimate their frequency: 

Allergic reactions. The main symptoms are itching, rash, urticaria (slightly itchy skin patches that are paler or redder than surrounding skin), severe difficulty breathing, nausea, vomiting and malaise. Bleeding from the back passage (rectum). Increased levels of certain liver enzymes can be detected in blood tests, diverticulitis, gallstones, hepatitis (inflammation of the liver), pancreatitis (inflammation of the pancreas), skin blistering (including those that burst), effects clotting with anti-coagulants. If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

 

 HOW TO STORE XENICAL

 

Keep out of reach of children.

 

Blister packs

 

Do not use Xenical after the expiry date stated on the carton.

Do not store above 25 ° C.

Store in the original package to protect from moisture.

 

Bottles

Do not use Xenical after the expiry date stated on the bottle.

Do not store above 30 ° C.

Keep container tightly closed in order to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

 

 ADDITIONAL INFORMATION

 

What Xenical

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

 The other ingredients are: microcrystalline cellulose (E 460), sodium starch glycolate, povidone (E 1201), sodium lauryl sulfate and talc. 

The capsule shell contains gelatin, indigo carmine (E132), titanium dioxide (E171) and edible printing ink.