Xenical 120 mg. 42 capsules
What XENICAL is and what it is used for
Xenical is a medicine that is used to treat obesity. It works in your digestive system, 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, preventing the breakdown of some of the fats you take with your food. Unused fat cannot be taken in and eliminated from the body.
Xenical is indicated for the treatment of obesity along with a low calorie diet.
2. 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 of Xenical,
• if you have chronic malabsorption syndrome (insufficient digestion of nutrients from the digestive system),
• if you have bile stagnation (liver disorder)
• if you are breast-feeding.
Warnings and precautions
Weight loss can also have an effect on doses of medicines taken for other conditions (eg high cholesterol or diabetes). Be sure to discuss with your doctor these and other medicines you may be taking. Weight loss may mean that a dose adjustment of these drugs is needed.
To maximize the effect of Xenical treatment, you must follow the diet prescribed by your doctor. As with other weight control programs, overuse of fat and calories can reduce the effect of losing this medicine. It can cause harmless changes in bowel movements, such as fatty stools, due to the excretion of unprocessed fat in them. This can be increased if Xenical is taken with a high fat meal. In addition, the intake of fat during the day should be evenly distributed between the three main meals, because if Xenical is taken with a high-fat meal, the likelihood of gastrointestinal effects may increase.
It is recommended to use an additional method of preventing pregnancy to avoid possible failure of oral contraceptives that may occur in severe diarrhea.
The use of orlistat may be associated with kidney stones in patients with chronic kidney disease. Tell your doctor if you have kidney problems.
Xenical is not intended for use in children.
Other medicines and Xenical
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 because the administration of more than one drug at the same time may enhance or attenuate the effect of the drugs.
Xenical may change the effect of:
• Anti-clotting drugs (eg warfarin). Your doctor may need to monitor your blood clotting.
• Cyclosporine. Co-administration with ciclosporin is not recommended. Your doctor may need to monitor your blood levels of ciclosporin more often than usual.
• Iodine salts and / or levothyroxine. Hypothyroidism and / or decreased control of hypothyroidism may occur.
• Amiodarone. You should consult your doctor.
• Medicines for the treatment of HIV.
• Medicines for the treatment of depression, mental disorders or anxiety.
Xenical reduces the absorption of certain fat-soluble nutrients, especially beta-carotene and vitamin E. Therefore, you should follow your doctor’s advice and follow a well-balanced diet rich in fruits and vegetables. Your doctor may advise you to take more multivitamins.
Orlistat can unbalance anti-seizure treatment by reducing the absorption of anti-epileptic drugs, which can lead to seizures. Please contact your doctor if you think the frequency and / or severity of the seizures has changed when you are taking Xenical with anti-epileptic medicines.
Xenical is not recommended in people who take acarbose (an anti-diabetic medicine used to treat type 2 diabetes).
Xenical with food and drink
Xenical can be taken immediately before, during or up to 1 hour after a meal. The capsule should be swallowed with water.
Pregnancy and breastfeeding
Taking Xenical during pregnancy is not recommended.
You should not breast-feed your baby during treatment with Xenical as it is not known whether Xenical is excreted in human breast milk.
Driving and using machines
Xenical is not known to affect the ability to drive or use machines.
How to take XENICAL
Always take Xenical exactly as your doctor has told you. If you are 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 up to one hour after meals. The capsule should be taken 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% of calories derived from fat. Your daily intake of fats, carbohydrates and proteins should be divided into three main meals. This means that you should usually take one capsule at breakfast, one capsule at lunch and one capsule at dinner. For maximum effect, avoid eating foods containing cookies such as cookies, chocolate, and savory snacks between main meals.
Xenical only works in the presence of dietary fat. Therefore, if you miss a basic meal or eat non-fat foods, you do not need to take Xenical.
Please tell your doctor if for some reason you have not taken the medicine exactly as prescribed. Otherwise, the doctor may be left with the impression that the medicine is not effective or is not well tolerated and may change your treatment as needed.
Your doctor will discontinue treatment with Xenical after 12 weeks if you have not reduced your body weight by at least 5% compared to starting treatment with Xenical.
Xenical has been studied in long-term clinical trials of up to 4 years duration.
If you take more XENICAL than you should
If you take more capsules than you prescribed, 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 the medicine, take it as soon as you remember, if it has not been more than an hour since your last meal, then resume your usual time. Do not take a double dose. If you miss more doses, please tell your doctor and follow his instructions.
Do not change your prescribed dose unless you have been told by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. 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 are not feeling well while taking Xenical.
Most of the side effects associated with Xenical administration are due to its local action in the digestive system. These symptoms are usually mild, occur at the beginning of treatment, and occur mainly after ingestion of high fat foods. Usually, these symptoms disappear if you continue your treatment and follow your prescribed diet.
Very common side effects (affects more than 1 in 10 people)
Headache, abdominal pain / discomfort, urgent or more frequent need for bowel emptying, flatulence (gas) with discharge, fat secretion, fatty stools, liquid stools, low blood sugar (occurs in some people with type 2 diabetes ).
Common side effects (affects 1 to 10 people in 100)
Rectal pain / discomfort, soft stools, involuntary discharge of stools, swelling (occurs in some people with type 2 diabetes), tooth / gum problems, irregular menstrual cycles, fatigue.
The following side effects have also been reported, but no frequency estimate can be made from the available data:
Allergic reactions: The main symptoms are itching, rash, urticaria (slightly convex, itchy skin areas that are paler or redder than the surrounding skin), severe breathlessness, nausea, vomiting and malaise. Formation of skin blisters (including blisters). Diverticulitis. Bleeding from the lower floor of the digestive system (rectum). Increased levels of some liver enzymes may be detected in blood tests. Hepatitis (inflammation of the liver). Symptoms may include yellowing of the skin and eyes, itching, dark staining of urine, abdominal pain and tenderness of the liver (manifesting with pain from below the ribs to the right), sometimes with loss of appetite. If you experience such symptoms, stop using Xenical and tell your doctor. Gallstones. Pancreatitis (inflammation of the pancreas). Oxalate nephropathy (accumulation of calcium oxalate, which can lead to the formation of kidney stones). See section 2 Take special care with Xenical. Effects on blood clotting in the use of anticonvulsant drugs.
How to store XENICAL
Keep out of the reach and sight of children.
Do not use Xenical after the expiry date which is stated on the carton.
Do not store above 25 ° C.
Keep blisters in the original package in order to protect from light and moisture. Glass bottles
Do not use Xenical after the expiry date which is stated on the bottle.
Do not store above 30 ° C.
Keep the package tightly closed to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What XENICAL contains
• The active substance is orlistat. Each capsule contains 120 mg orlistat.
• The other ingredients are: microcrystalline cellulose (E460), sodium starch glycolate (type A), povidone (E1201), sodium lauryl sulfate and talc. The capsule contains gelatin, indigo carmine (E 132), titanium dioxide (E 171) and harmless print ink.
What XENICAL looks like and contents of the pack
Xenical capsules are turquoise, labeled “XENICAL 120” and are available in blister packs and glass bottles containing 21, 42 and 84 capsules.
Not all pack sizes may be marketed.