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Read this Patient Information before you start taking XENICAL and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
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Rare cases of increase in xenical australia buy and in alkaline phosphatase and hepatitis that may be serious have been reported. There have been reports of hepatic failure observed with the use of Xenical in postmarketing surveillance.with some of these cases resulting in liver transplant or death [see Warnings and Precautions (5.2)] . Rare cases of hypersensitivity have been reported with the use of Xenical. Signs and symptoms have included pruritus.rash.urticaria.angioedema.bronchospasm and anaphylaxis. Very rare cases of bullous eruption have been reported. Rare cases of leukocytoclastic vasculitis have been reported. Clinical signs include palpable purpura.maculopapular lesions.or bullous eruption. Acute oxalate nephropathy after treatment with Xenical has been reported in patients with or at risk for renal disease [see Warnings and Precautions (5.3)] . Pancreatitis has been reported with the use of Xenical in postmarketing surveillance. No causal relationship or physiopathological mechanism between pancreatitis and obesity therapy has been definitively established. Lower gastrointestinal bleeding has been reported in patients treated with Xenical. Most reports are nonserious. severe or persistent cases should be investigated further.
Loss of virological control has been reported in HIV-infected patients taking orlistat concomitantly with antiretroviral drugs such as atazanavir.ritonavir.tenofovir disoproxil fumarate.emtricitabine.and with the combinations lopinavir/ritonavir and emtricitabine/efavirenz/tenofovir disoproxil fumarate. The exact mechanism for this is unclear.but may include a drug-drug interaction that inhibits systemic absorption of the xenical australia buy drug. HIV RNA levels should be frequently monitored in patients who take XENICAL while being treated for HIV infection. If xenical australia buy xenical australia buy a confirmed increase in HIV viral load.XENICAL should be discontinued.
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treatment with xenical may result in weight loss and improvement in obesity-related risk factors due to weight loss see clinical studies 14 .
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Liver problemsnauseaupper stomach painitchingtired feelingloss of appetitedark urineclay-colored stoolsjaundiceyellowing of the skin or eyes
Do not increase your dose or use this drug more often or for longer than prescribedYour condition will not improve any fasterand your risk of side effects will increase.
Because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and betacarotenepatients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutritionsee WARNINGS AND PRECAUTIONSThe vitamin supplement should be taken at least 2 hours before or after the administration of XENICALsuch as at bedtime.
The following adverse reactions have been identified during postapproval use of XENICALBecause these reactions are reported voluntarily from a population of uncertain sizeit is not always possible to reliably estimate their frequency or establish a causal relationship to XENICAL exposure.
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.
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generic xenical should not be taken in excess as it may lead to severe health complications doctor s consultation is required before starting this medication, particularly about allergy problems, and kidney or liver disorders pregnant women should not take generic xenical pill as it may adversely affect the health of the fetus similarly, mothers who breast-feed their baby should not consume this drug as it may harm the health of their baby a user may be asked to take a multivitamin while taking this medication as the drug can cause certain vitamin deficiencies avoid excess intake of fatty food while taking generic xenical as it may cause bothersome intestinal-related side effects.
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Orlistat had no detectable mutagenic or genotoxic activity as determined by the Ames testa mammalian forward mutation assayV79/HPRTan in vitro clastogenesis assay in peripheral human lymphocytesan unscheduled DNA synthesis assayUDSin rat hepatocytes in cultureand an in vivo mouse micronucleus test.
If your doctor has prescribed this medicationread the Patient Information Leaflet if available from your pharmacist before you start taking orlistat and each time you get a refillTake this medication as directed by your doctorby mouth with liquid sometime during each meal that contains fat or within 1 hour after the mealusually 3 times dailyIf you miss a meal or your meal contains no fatskip that dose of the medicationTo decrease the chance of unpleasant side effectsit is very important that no more than 30of the calories in your diet come from fatYour daily intake of fatproteinand carbohydrates should be evenly spread over 3 main meals.
In controlled clinical trials8.8of patients treated with XENICAL discontinued treatment due to adverse eventscompared with 5.0of placebo-treated patientsFor XENICALthe most common adverse events resulting in discontinuation of treatment were gastrointestinal.
You should see some weight loss within 2 weeks after you start orlistatTell your doctor if your condition does not improve or if it worsens.
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This is not a complete list of side effects and others may occurCall your doctor for medical advice about side effectsYou may report side effects to FDA at 1-800-FDA-1088.
Based on fecal fat measurementsthe effect of XENICAL is seen as soon as 24 to 48 hours after dosingUpon discontinuation of therapyfecal fat content usually returns to pretreatment levels within 48 to 72 hours.
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Hypothyroidism has been reported in patients treated concomitantly with XENICAL and levothyroxine postmarketingPatients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid functionAdminister levothyroxine and XENICAL at least 4 hours apartsee DOSAGE AND ADMINISTRATION
For patients receiving both XENICAL and levothyroxine therapyadminister levothyroxine and XENICAL at least 4 hours apartPatients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function.
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