Orlistat full prescribing information

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Two patients died from liver failure. There has been limited experience of this treatment, which is only available in injectable form. Bariatric surgery for obesity and metabolic conditions in adults.

Doctors have guidelines as to when orlistat can be prescribed. One reason why orlistat may not work is that you may think that you can relax your weight-reducing diet, and the orlistat will ‘do it all’. It is currently mainly being used in specialist centres for people whose obesity has led them to develop other illnesses such as diabetes.

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There were no signals of significant liver injury in either the pre-clinical studies or clinical trials data. Orlistat is not used in everyone who wants to lose weight. Your contact details as the reporter of the side-effect. 7 2a1 1 0 0 1-. This is a condition where bile does not flow properly from the liver to the duodenum. Orlistat can also interfere with the absorption of various medicines and vitamins and affect the way that they work.

Your BMI must be 28 or above. If you think you have had a side-effect to one of your medicines you can report this on the Yellow Card Scheme. Severe liver injury can occur in people not taking drugs and without a distinct cause.

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Nearly a third of the fat that you eat is blocked by orlistat. Your pharmacist will also give you advice on an appropriate diet – a low-calorie and low-fat diet. Twelve were foreign reports of severe liver injury with Xenical. They tend to settle with time, possibly because if they occur they remind you that you should be eating a low-fat diet.

Some patients in the reported cases also used other drugs or had other conditions that may have contributed to the development of severe liver injury. You can also buy orlistat from pharmacies – but certain conditions apply, detailed below. Tackling overweight and obesity: does the public health message match the science? For a doctor to prescribe orlistat, they also need to be sure that you have tried changing your diet and increasing your physical activity levels first.

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Royal College of Paediatrics and Child Health and Dept of Health. If you take orlistat, it may possibly interfere with the absorption of some vitamins, so you should take a multivitamin supplement at bedtime. Contact your healthcare professional if you develop itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools.

Take a multivitamin supplement at bedtime – a time when you will not be taking orlistat – to help ensure adequate vitamin intake. Did you find this information useful? Disclaimer: This article is for information only and should not be used for the diagnosis or treatment of medical conditions. The name of the medicine which you think caused it. Some treatments for HIV and AIDS. Why not subscribe to the newsletter?

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Two other medicines – sibutramine and rimonabant – previously used to help with weight loss are no longer available in the UK because of concerns over their safety. FDA identified 12 postmarketing cases of severe liver injury reported with the use of Xenical and one case reported with the use of Alli. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. You may have fatty smelly stools, urgency to get to the toilet, oily spotting on your underclothes, and excess wind. Buying drugs in your country requires a prescription. Avoid skin on chicken and crackling on pork.

Studies have shown that, on average, orlistat, plus a weight-reducing diet and exercise, causes more weight loss than a weight-reducing diet and exercise alone. If you continue to lose weight after six months, your doctor may advise that you continue to take orlistat. In others, it is less effective. At this time, a cause and effect relationship of severe liver injury with orlistat use has not been established.

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If you take the contraceptive pill and have severe diarrhoea you should use other methods of contraception in addition to the pill – for example, condoms. Be aware that cases of severe liver injury have been reported rarely in people taking Xenical and Alli. Please see the leaflet that comes with your medicine for a full list of possible side-effects and cautions. Orlistat is a medicine which can help you to lose weight if you are overweight or obese. You must be over the age of 18 years. Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of this medication.

Because of the seriousness of severe liver injury, FDA has added information about reported cases of severe liver injury to the label of Xenical and Alli to educate the public about the signs and symptoms of liver injury and the need to see a physician promptly should they occur. People under the age of 18 years. Your BMI should be checked on each occasion that you request orlistat. Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat.

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These may be signs of liver injury. The information on this page is written and peer reviewed by qualified clinicians. Obesity and Management of Weight Loss. Alli and 12 foreign cases with Xenical reported between April 1999 and August 2009 out of an estimated 40 million people worldwide who have used Xenical or Alli. Note: the above is not the full list of side-effects for those taking orlistat. Association of all-cause mortality with overweight and obesity using standard body mass index categories: a systematic review and meta-analysis.

Effects of orlistat on blood pressure: a systematic review and meta-analysis of 27 randomized controlled clinical trials. In order to lose weight you still have to eat less and exercise regularly. Liraglutide is a new medicine that was licensed for the treatment of obesity in January 2017. You should not take orlistat for more than six months over the counter. Always read the packet leaflet for a full list of cautions and of people who should not take orlistat.

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The agency is also adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for Alli and is working with the manufacturer to ensure that consumers can understand this new warning. Buying drugs in your country requires a prescription. Talk to your healthcare professional about any concerns you have with these medications. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U. Reported side-effects of eating too much fat include: flatulence, oily spotting on underwear, increased urgency and loose bowel movements. Consult a doctor or other health care professional for diagnosis and treatment of medical conditions.

If you have not lost weight after taking orlistat for three months, you should not continue to take it. Our clinical information is certified to meet NHS England’s Information Standard. Weigh the benefits of weight-loss with Xenical and Alli against the potential risks when determining if these medications are appropriate for patients. Patient does not provide medical advice, diagnosis or treatment.

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12 foreign reports with Xenical and 1 U. Patient Platform Limited has used all reasonable care in compiling the information but make no warranty as to its accuracy. Be aware that postmarketing cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported rarely in people using Xenical and Alli. Orlistat works by interfering with the way that fat is digested and absorbed into the body. Choose lower-fat cook-in sauces with less than 5 g fat per 100 g sauce.

One way to help with weight loss is to reduce the amount of fat in your diet. The person who had the side-effect. Assess your symptoms online with our free symptom checker. Some of these cases resulted in liver transplant or death. If liver injury is suspected, orlistat and other suspect medications should be discontinued immediately and liver function tests and ALT and AST levels obtained. Sections or subsections omitted from the prescribing information are not listed.

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Surgery for weight loss in adults. Pharmacists cannot just sell it to anyone. Xenical through August 7, 2009, and a review of postmarket data on Alli through October 1, 2008.

You can do this online at www. In some of these cases, other factors or drugs may have contributed to the development of severe liver injury. It is only recommended in people over a certain BMI.