What Xenical is and what it is used for
Xenical is a drug used to treat obesity. It works in your digestive system and blocks about a third of the fat in the food you eat from being absorbed by the gut.
Xenical binds to enzymes in your digestive system ( lipases ) and blocks them from breaking down some of the fat you’ve eaten during your meal. The fat that has not been broken down cannot be absorbed but removed by the body.
Xenical is used for the treatment of obesity together with the intake of a low-calorie diet.
What you need to know before taking Xenical
Do not take Xenical
- if you are allergic (hypersensitive) to orlistat or any of the other ingredients in Xenical
- if you have chronic malabsorption syndrome (insufficient absorption of nutrients during digestion)
- if you have cholestasis (liver disease)
- if you are breastfeeding
Warnings and precautions
Weight loss can also affect the dose of medicines you take for other conditions (e.g. high cholesterol levels or diabetes ). Therefore, remember to tell your doctor if you are taking these or other medicines. Weight loss may lead to you needing to adjust the dose of one of these medicines.
To get the maximum effect of Xenical, you should follow the diet program recommended by your doctor. As with other weight loss programs, an excessive intake of fat and calories can hinder weight loss.
This medicine may cause harmless changes in bowel movements. The stool may become more fatty and oily because your stool contains fat that has not been broken down. The risk of this happening increases if you take Xenical with fatty foods. The daily fat intake should therefore be distributed evenly over the three main meals of the day, as gastrointestinal problems are likely to increase if Xenical is taken together with a very high-fat meal.
The use of an additional contraceptive is recommended to prevent a possible failure of oral contraceptives that can occur in severe diarrhea.
The use of orlistat may be associated with kidney stones in patients suffering from chronic kidney disease. Inform your doctor if you suffer from problems with your kidneys.
Children
Xenical is not intended for the treatment of children.
Other medicines and Xenical
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
This is important because the use of more than one medicine at the same time can lead to the effect of one of these medicines is enhanced or worsened.
Xenical can change the effect of
- Medicines against blood clots (eg warfarin ). Your doctor may need to check your blood’s ability to clot.
- Cyclosporine. Concomitant intake of ciclosporin is not recommended. Your doctor may need to check your cyclosporine blood levels more often than usual.
- Iodine salts and/or levothyroxine. Decreased thyroid function and/or reduced control of decreased thyroid function may occur.
- Amiodarone. Ask your doctor for advice on simultaneous administration.
- Medicines for the treatment of HIV.
- Medicines for depression, mental disorders, or anxiety.
Xenical reduces the absorption of certain fat-soluble nutrients, especially beta-carotene and vitamin E. You should therefore follow the advice you receive from your doctor to eat a well-balanced diet rich in fruit and vegetables. Your doctor may suggest that you supplement with a multivitamin preparation.
Orlistat can cause anti-epileptic drugs to becoming unbalanced by reducing the absorption of the anti-epileptic drug. This can lead to seizures. Contact a doctor if you think the frequency and/or severity of seizures has changed when using Xenical together with anti-epileptic drugs.
Xenical is not recommended for people taking acarbose (an antidiabetic medicine used to treat type 2 diabetes mellitus ).
Xenical with food and drink
Xenical can be taken just before, during a meal, or up to one hour after a meal. The capsule should be swallowed with water.
Pregnancy and breastfeeding
Taking Xenical during pregnancy is not recommended.
You should not breastfeed your child during treatment with Xenical because it is not known whether Xenical passes into breast milk.
Driving ability and use of machinery
Xenical has no known effect on your ability to drive or use machines.
How to take Xenical
Always take Xenical as directed by your doctor. Ask your doctor or pharmacist if you are unsure. The usual dose of Xenical is one 120 mg capsule taken with each of the three main meals of the day. Dose one can be taken just before, with the meal, or within an hour after the meal. The capsules should be swallowed with water.
Xenical should be taken together with a well-balanced, low-calorie diet rich in fruit and vegetables, with approximately 30% of calories coming from fat. Your daily intake of fat, carbohydrates, and protein should be spread over three meals, which means you usually take one capsule for breakfast, one capsule for lunch, and one capsule for dinner. To achieve the best results with the treatment, you should avoid fatty foods between meals such as cakes, chocolate, and snacks.
Xenical only works in the presence of food containing fat. You, therefore, do not need to take Xenical if you have missed a meal or if you eat a meal that does not contain any fat.
Tell your doctor if you have not taken your medicine as you were told to. Otherwise, your doctor may think that the medicine was not effective or that you did not tolerate it and may therefore change your treatment unnecessarily.
If after 12 weeks you have not lost at least 5% of the body weight measured at the start of Xenical treatment, your doctor will stop your treatment with Xenical.
Xenical has been investigated in long-term studies of up to 4 years of treatment.
If you have taken too much Xenical
If you take more capsules than you were instructed to take or if someone else accidentally takes your medicine, contact your doctor, pharmacist, or hospital as medical attention may be needed.
If you forget to take Xenical
If you forget to take your medicine at any time, take it as soon as you remember within one hour of the last meal, and then continue to take the medicine as usual at the next meal. Do not take a double dose. If you forget to take several doses in a row, inform your doctor and follow the advice given to you.
Do not change the prescribed dose unless your doctor tells you to.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, Xenical can cause side effects, but not everybody gets them.
Tell your doctor or pharmacist as soon as possible if you do not feel well from Xenical.
Most of the unwanted effects that can occur during treatment with Xenical are due to the drug’s local action in the digestive system. These symptoms are usually mild and occur at the beginning of the treatment and occur mainly after eating high-fat meals. Normally these symptoms disappear if you continue the treatment and stick to the recommended diet.
Very common side effects (affects more than 1 user in 10)
Headache, abdominal pain/discomfort, urgent or increased need to have a bowel movement, flatulence with bowel movements, oily stools, fatty/oily stools, runny stools, and low blood sugar levels (in some patients with type 2 diabetes ).
Common side effects (affects 1 to 10 users in 100)
Rectal pain/discomfort, loose stools, incontinence (feces), bloating (in some patients with type 2 diabetes ), tooth/gum problems, irregular menstrual bleeding, and fatigue.
The following side effects have also been reported but their frequency cannot be determined from the available data:
Allergic reactions. The main symptoms are itching, rash, hives (slightly raised, itchy patches of skin that are paler or redder than surrounding skin), severe breathing difficulties, nausea, vomiting, and feeling unwell. Skin blisters (with blisters that burst). Diverticulitis (infected bowel pouches). Bleeding from the tail ( rectum ). Elevated liver enzyme levels can be found in blood tests. Hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and whites of the eyes, itching, dark-colored urine, abdominal pain, and tenderness over the liver (appears as pain under the front of the chest on your right side), sometimes with decreased appetite. Stop taking Xenical if such symptoms occur and contact your doctor. Gallstones. Pancreatitis (inflammation of the pancreas). Oxalate nephropathy (formation of calcium oxalate which can lead to kidney stones ). See section 2, Take special care with Xenical. Effects on coagulation with anticoagulants.
How to store Xenical
Store out of sight and reach of children.
Blister packs
Use before the expiry date stated on the carton.
Store at a maximum of 25 ºC.
Store in the outer carton. Light sensitive. Moisture sensitive.
Glass jars
Use before the expiry date stated on the glass jar.
Store at a maximum of 30 ºC.
Close the package nicely. Moisture sensitive.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is orlistat. Each capsule contains 120 mg of orlistat.
- Other ingredients are microcrystalline cellulose (E460), sodium starch glycolate (type A), povidone (E1201), sodium lauryl sulfate, and talc. The capsule shell contains gelatin, indigo carmine (E132) and titanium dioxide (E171), and ink.
Appearance and package sizes of the medicine
Xenical capsules are turquoise and labeled “XENICAL 120” and are available in blister packs and glass jars, containing 21, 42, or 84 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Bahnhofstr. 1a
17498 Mesekenhagen
Germany