Some fatal cases or cases requiring liver transplantation have been reported.Reporting suspected adverse reactions after authorisation of the medicinal product is important. The orange oily poo is correct. Ciclosporin blood levels should be monitored until stabilised.In the absence of pharmacokinetic interaction studies, the concomitant administration of orlistat with acarbose should be avoided.When warfarin or other anticoagulants are given in combination with orlistat, international normalised ratio (INR) values should be monitored (see section 4.4).Treatment with orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K). Orlistat, M1 and M3 are all subject to biliary excretion.Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.In animal reproductive studies, no teratogenic effect was observed. The review included non-clinical, clinical trial, and post-marketing safety data provided by the licence holders and a review of suspected adverse reaction reports submitted to the MHRA. The mean difference in weight loss with the drug compared to placebo was 3.2 kg.Data from the 4-year XENDOS clinical trial showed that 60 % of orlistat patients and 35 % of placebo patients demonstrated a loss of at least 5 % of their baseline body weight after 12 weeks of treatment. Therefore, these patients should be monitored for possible changes in the frequency and/or severity of convulsions.Rare occurrence of hypothyroidism and/or reduced control of hypothyroidism may occur. Therefore the combination is not recommended (see section 4.4).However, if such concomitant use is unavoidable, more frequent monitoring of ciclosporin blood levels should be performed both after addition of orlistat and upon discontinuation of orlistat in ciclosporin treated patients.

Based on a study in obese patients, of the minimal fraction of the dose that was absorbed systemically, two major metabolites, M1 (4-member lactone ring hydrolysed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42 % of the total plasma concentration.M1 and M3 have an open beta-lactone ring and extremely weak lipase inhibitory activity (1000 and 2500 fold less than orlistat respectively). Overall, after one year of treatment, the percentage of patients taking 120 mg orlistat who lost 10 % or more of their body weight was 20 % with orlistat 120 mg compared to 8 % of patients taking placebo. The absence of these interactions has been demonstrated in specific drug-drug-interaction studies.The absence of an interaction between oral contraceptives and orlistat has been demonstrated in specific drug-drug interaction studies. This could be due to decreased absorption of iodine salts or levothyroxine (or both).


If this occurs, consideration could be given to administering orlistat and antiepileptic drugs at different times.Pancreatitis has also been added as an undesirable effect of alli treatment after reports in a number of patients (frequency unknown).We are aware that consumers may be at risk after reports in the USA of counterfeit alli that contained In July 2009, there was a Europe-wide review of a possible association between orlistat and serious hepatic reactions. By continuing to browse the site you are agreeing to our policy on the use of cookies. The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine (see section 4.5).Antiepileptics patient: Orlistat may unbalance anticonvulsivant treatment by decreasing the absorption of antiepileptic drugs, leading to convulsions (see section 4.5).Antiretrovirals for HIV: Orlistat may potentially reduce the absorption of antiretroviral medicines for HIV and could negatively affect the efficacy of antiretroviral medications for HIV (see section 4.5).A decrease in ciclosporin plasma levels has been observed in a drug-drug-interaction study and also reported in several cases, when orlistat was administered concomitantly. Download. I've had 2 very unfortunate incidents, both on a golf course, one of which resulted in me not making it in time and as a result what a mess. While you would still attempt to eat a calorie-reduced meal, Orlistat would assist in weight loss by preventing up to 30% of the fat in your meal from being absorbed.
Plasma concentrations of intact orlistat were non- measurable (< 5 ng/ml) eight hours following oral administration of orlistat.In general, at therapeutic doses, detection of intact orlistat in plasma was sporadic and concentrations were extremely low (< 10 ng/ml or 0.02 μmol), with no evidence of accumulation, which is consistent with minimal absorption.The volume of distribution cannot be determined because the drug is minimally absorbed and has no defined systemic pharmacokinetics.

In order to ensure adequate nutrition, patients on a weight control diet should be advised to have a diet rich in fruit and vegetables and use of a multivitamin supplement could be considered.

Orlistat is a potent, specific, and long-acting inhibitor of gastrointestinal lipases. Approximately 97 % of the administered dose was excreted in faeces and 83 % of that as unchanged orlistat.The cumulative renal excretion of total orlistat-related materials was < 2 % of the given dose. The daily intake of fat should be distributed over three main meals. It is not known whether these findings translate into long-term clinical benefits.In obese type 2 diabetic patients insufficiently controlled by antidiabetic agents, data from four one year clinical trials showed that the percentage of responders (≥ 10 % of body weight loss) was 11.3 % with orlistat as compared to 4.5 % with placebo. Antidiabetic medicinal product treatment may have to be closely monitored when taking orlistat.Co-administration of orlistat with ciclosporin is not recommended (see section 4.5).Patients should be advised to adhere to the dietary recommendations they are given (see section 4.2).The possibility of experiencing gastrointestinal adverse reactions (see section 4.8) may increase when orlistat is taken with a diet high in fat (e.g.