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XENICAL inhibited absorption of a vitamin E acetate supplement. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese. If you would like more information, talk with your doctor. Lower gastrointestinal bleeding has been reported in patients treated with XENICAL.
Xenical attaches to the enzymes in your digestive system, known as lipases which are blocked from breaking down some of the fat you have eaten during your meal. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Potential Risks And Benefits Patients should be informed of potential risks which include lowered absorption of fat-soluble vitamins and potential liver injury, increases in urinary oxalate, and cholelithiasis . Patients should not take XENICAL if they are pregnant, have chronic malabsorption syndrome, cholestasis or hypersensitivity to XENICAL or to any component of this product .
Take XENICAL with your meals or up to one hour after your meal. These are not all the possible side effects of XENICAL. The effect is the percentage of ingested fat excreted, referred to as fecal fat excretion percentage.
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The diet utilized during year 2 was designed for weight maintenance and not weight loss. Based on patients with a baseline and at least one follow-up OGTT measurement, ITT LOCF study population. Table 4 illustrates the percentage of adult patients on XENICAL and placebo who developed a low vitamin level on two or more consecutive visits during 1 and 2 years of therapy in studies in which patients were not previously receiving vitamin supplementation.
Talk to your doctor right away if your seizures happen more often or get worse while you take XENICAL. Clinical Studies The long-term effects of XENICAL on morbidity and mortality associated with obesity have not been established. Buying drugs in your country requires a prescription. Orlistat is a white to off-white crystalline powder.
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Find your medication Add your NHS prescription to the basket or search for your private prescription. XENICAL should not be used after the given expiration date. If you have any questions or concerns, please speak to your GP in the first instance. Buying drugs in your country requires a prescription. Buying drugs in your country requires a prescription.
At which point your order will be dispatched. This treatment can be obtained through our Online Doctor service. 6 out of 6 people found this useful. Pharmacokinetics Absorption Systemic exposure to orlistat is minimal. Patients should be advised to adhere to dietary guidelines .
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Pediatric Patients In clinical trials with XENICAL in adolescent patients ages 12 to 16 years, the profile of adverse reactions was generally similar to that observed in adults. Discontinuation Of Treatment In controlled clinical trials, 8. A reduced therapeutic effect of amiodarone is possible. 2, with black printing ink containing pharmaceutical grade shellac, propylene glycol, strong ammonium solution, potassium hydroxide and black iron oxide.
XENICAL 120 mg Capsules: Turquoise, two-piece, No. All studies, with the exception of 14 161, were conducted at centers specialized in treating obesity and complications of obesity. Take a multivitamin containing vitamins A, D, E, K, and beta-carotene one time each day. The relative changes in risk factors associated with obesity following 1 year of therapy with XENICAL and placebo are presented for the population as a whole and for the population with abnormal values at randomization. Call your doctor for medical advice about side effects. Read this Patient Information before you start taking XENICAL and each time you get a refill.
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Population With Abnormal Risk Factors at Randomization The relative differences in risk factors between treatment with XENICAL and placebo were similar to the results following 1 year of therapy for LDL- and HDL-cholesterol, triglycerides, fasting insulin, diastolic blood pressure, and waist circumference. The majority of unwanted effects related to the use of Xenical result from its local action in your digestive system. XENICAL 120 mg three times a day and with an incidence that was greater than placebo during year 1 and year 2, regardless of relationship to study medication. Safely throw away medicine that is out of date or no longer needed. You can ask your pharmacist or doctor for information about XENICAL that is written for health professionals. Specific Populations No pharmacokinetic study was conducted for specific populations such as geriatric, different races, and patients with renal and hepatic impairment.
In a clinical trial of XENICAL for the prevention of type 2 diabetes, the rates of cholelithiasis as an adverse event were 2. Do not take XENICAL if you are pregnant or plan to become pregnant. Rare cases of increase in transaminases and in alkaline phosphatase and hepatitis that may be serious have been reported. OVERDOSE Single doses of 800 mg XENICAL and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings. Checkout and pay If you’re done shopping, proceed to the checkout and pay for your order.
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Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established. 1 Oily discharge may be clear or have an orange or brown color. In several studies of up to 6-weeks duration, the effects of therapeutic doses of XENICAL on gastrointestinal and systemic physiological processes were assessed in normal weight and obese subjects. Study 14 161 was conducted with primary care physicians.
Therefore, XENICAL and cyclosporine should not be simultaneously coadministered. Cyclosporine should be administered 3 hours after the administration of XENICAL . Levothyroxine Hypothyroidism has been reported in patients treated concomitantly with XENICAL and levothyroxine postmarketing. It is not known if XENICAL passes into your breast milk.
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Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function. Weight-loss may affect glycemic control in patients with diabetes mellitus. Oral Contraceptives In 20 normal-weight female subjects, the treatment of XENICAL 120 mg three times a day for 23 days resulted in no changes in the ovulation-suppressing action of oral contraceptives. Use of XENICAL in this age group is supported by evidence from adequate and well-controlled studies of XENICAL in adults with additional data from a 54-week efficacy and safety study and a 21- day mineral balance study in obese adolescent patients aged 12 to 16 years. Plasma concentrations of orlistat and its metabolites M1 and M3 were similar to those found in adults at the same dose level. What are the ingredients in XENICAL?
Find the height closest to your height in the left-hand column. XENICAL discontinued treatment due to adverse events, compared with 5. If you take a multivitamin, take it at least 2 hours before or after you take XENICAL. XENICAL-treated patients and increased by an average of 0. Your GP can assess whether your current weight is healthy by measuring your Body Mass Index. Fat-soluble Vitamin Supplements And Analogues Data from a pharmacokinetic interaction study showed that the absorption of beta-carotene supplement is reduced when concomitantly administered with XENICAL.
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Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to XENICAL exposure. CLINICAL PHARMACOLOGY Mechanism Of Action Orlistat is a reversible inhibitor of gastrointestinal lipases. Then move across the top row to find the weight closest to your weight. HDL ratio and isolated systolic blood pressure were less than that observed in the year one results. Orlistat has no pK within the physiological pH range. Four-year Results : Long-term Weight Control And Risk Factors In the 4-year double-blind, placebo-controlled XENDOS study, the effects of XENICAL in delaying the onset of type 2 diabetes and on body weight were compared to placebo in 3304 obese patients who had either normal or impaired glucose tolerance at baseline.
Liver Injury There have been rare postmarketing reports of severe liver injury with hepatocellular necrosis or acute hepatic failure in patients treated with XENICAL, with some of these cases resulting in liver transplant or death. Cholelithiasis Substantial weight loss can increase the risk of cholelithiasis. Because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and betacarotene, patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition . Please ensure that you read all packaging and leaflets thoroughly before use.
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Your GP or a practice nurse can help you to assess your current diet and levels of physical activity, helping to set your personal weight loss goals. 24 hours in XENICAL and placebo treatment groups, respectively. Should a significant overdose of XENICAL occur, it is recommended that the patient be observed for 24 hours. Onset of Type 2 Diabetes in Obese Patients In the XENDOS trial, in the overall population, XENICAL delayed the onset of type 2 diabetes such that at the end of four years of treatment the cumulative incidence rate of diabetes was 8.
Buying drugs in your country requires a prescription. This information does not take the place of talking to your doctor about your medical condition or your treatment. Postmarketing Experience The following adverse reactions have been identified during postapproval use of XENICAL. In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed. You may report side effects to FDA at 1-800-FDA-1088. In the 4-year XENDOS study, the general pattern of adverse events was similar to that reported for the 1- and 2-year studies with the total incidence of gastrointestinal-related adverse events occurring in year 1 decreasing each year over the 4-year period.
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A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Buying drugs in your country requires a prescription. Side effects are usually temporary with continued treatment or disappear when you stop tacking the medicine. Acute oxalate nephropathy after treatment with XENICAL has been reported in patients with or at risk for renal disease .
BMI and body weight after 52 weeks of treatment for the intent-to-treat population are presented in Table 12. Alternatively, contact our Online Clinic team for further assistance. Buying drugs in your country requires a prescription. The vitamin supplement should be taken at least 2 hours before or after the administration of XENICAL, such as at bedtime. Amiodarone A pharmacokinetic study, where amiodarone was orally administered during orlistat treatment, demonstrated a reduction in exposure to amiodarone and its metabolite, desethylamiodarone .