Xenical in australia

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Overview

Xenical Online Australia

Xenical 120mg capsules are available from our registered online doctor and pharmacy service. If you are eligible after completing an online assessment, a prescription from our Australian registered doctor will be issued free of charge and passed to our Australian pharmacy for dispensing, if appropriate.

Use in conjunction with a balanced meal plan and exercise.

Xenical is only used to treat patients with a body mass index (BMI) of OVER 30. If your BMI is lower than 30 this medicine may not be suitable for you and you should consult your GP for further advice. 

Xenical Summary

*The dose provided is from the consumer medicines information leaflet. Always use your prescription medication as prescribed by the doctor. For a full list of side effects read the consumer medicines information.

Xenical (Orlistat) Prices

*All prices include doctors assessment (prescription) and medicine.

FAQ

How to take Xenical

Take Xenical up to three times a day with main meals or up to one hour after main meals.

Where to buy Xenical in Australia?

You can buy Xenical online through an Australian registered online pharmacy or from a pharmacy from a pharmacist. Xenical 120mg capsules are available (if appropriate) after a health assessment with Simple Online Doctor.

How to buy Xenical

To buy Xenical, you must answer a series of questions relating to your condition and health. This includes medical conditions, current medicines, height, weight and lifestyle questions. Answering these questions allows the health professional to evaluate if the medicine is right for you.

How long does it take Xenical to work?

Xenical will begin to work rapidly after taking it with a meal. The long term effects of Xenical may take up to 2 weeks to show a noticeable result. Results will take time and can be affected by diet and exercise choices.

Do you need a prescription for Xenical in Australia?

No. You can buy Xenical over the counter. However, you do require an assessment from a registered health professional to ensure the medicine is suitable for you. The medicine can only be supplied to those with a body mass index of over 30 over the counter.

Side Effects

Xenical Side Effects

Like all medicines, there is the potential for some side effects from taking Xenical, although not everyone will experience them.

Common side effects of Xenical can include:

• fatty or oily stools
• needing the toilet urgently
• passing stools frequently
• oily discharge from your rectum (you may have oily spots on your underwear)
• flatulence (wind)
• stomach pain
• headaches

If you experience any side effects you find uncomfortable you should speak to your doctor or pharmacist.

This is not a full list of possible side effects. For a full list please read the consumer medicines information.

Info Leaflet

Before using any medication, it is important to read the consumer medicines information.

• Xenical Consumer Medicines Information

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Xenical (Orlistat)

Prolistat (Orlistat)

Xenical: Weight-loss wonder drug? | CHOICE

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We take a look at the concerns raised about the marketing of weight-loss drug orlistat (contained in the medicine Xenical).

Karina Bray

Last updated: 25 May 2016

Fact-checked

Checked for accuracy by our qualified fact-checkers and verifiers. Find out more about fact-checking at CHOICE.

Orlistat, sold in Australia as Xenical, is a drug that's promoted as a treatment for those who are overweight and obese. It works in your stomach and intestine by preventing your body from absorbing as much as 30% of the fat you eat, and as a result it can help you lose weight. 

But Xenical isn't the magic-bullet solution to obesity, and we have concerns about its over-the-counter availability at pharmacies.

On this page:

How does Xenical work?

Xenical helps you lose weight when used in conjunction with a reduced-fat diet and exercise program. Xenical is taken when you're eating fatty food, so you'll usually take a capsule with each of the three main meals a day (unless you know the meal you're eating contains no fat). You must limit the fat that you eat in a day to less than 12g in each meal, and no more than 40g per day. A really fatty meal can result in some unpleasant side effects.

A clinical trial has found that participants who took Xenical three times a day lost an average of 4.8kg in the first month, increasing up to 7.2kg at 3 months. After a year, the average loss was 10% of original body weight. A longer term study over four years showed a weight loss of 5.8kg in the Xenical group versus 3kg in a placebo group, with about one in four patients losing 10% or more body weight.

Possible risks and side effects of Xenical

Because you don't absorb all the fat you eat when taking Xenical, the most common side effects are gastro-intestinal problems, including:

• oily bowel movements
• frequent bowel motions and flatulence
• diarrhoea
• abdominal pain.

Xenical also affects the amount of fat-soluble vitamins and beta-carotene you absorb, so a vitamin supplement taken at least two hours before or after a dose of Xenical may be needed.

Who can use Xenical?

You're only eligible to take Xenical if you have:

• a BMI (body mass index) of 30 and over; or
• a BMI of 27 and over with other risk factors like diabetes or high blood pressure.

Xenical isn't currently recommended for children or teenagers under 18 years or adults over 74 years of age.

How much does Xenical cost?

Xenical costs approximately $120 for one month's supply.

How do you get it?

Xenical is available from pharmacies. You don't need a prescription, but before it can be sold pharmacists are supposed to assess you for suitability. They're expected to check:

• weight, height and BMI
• health status (existence of conditions such as diabetes, high blood pressure, osteoporosis, for example)
• age
• factors contributing to excess weight (including genetic influences, life states and events, and medical conditions or treatments).

If Xenical is dispensed, pharmacists should then give counselling on points including dosage, side effects and lifestyle modifications required (including diet and exercise).

However, we recommend seeing your doctor before getting Xenical. It's always sensible to be fully checked out before trying any new medication – your GP is the best person to advise you on your situation and help you decide on the best and safest way to tackle your problem.

What's the problem with Xenical being available without a prescription?

Originally when it went on sale in Australia, Xenical was a schedule 4 (S4, "prescription only") drug. But in October 2003 it was granted schedule 3 (S3, "pharmacist only") status, which meant it no longer requires a prescription.

Xenical has an important place in helping people who are obese or who are overweight with obesity-related health problems. But we're concerned that its S3 status means that Xenical is too easily accessed by people who shouldn't be taking it.

CHOICE shadow shop

In theory, there are guidelines for pharmacists to follow when supplying Xenical. These include an assessment that should consider BMI and waist circumference, health status and age, and counselling on points including dosage, drug interactions, side effects and advised lifestyle modifications (including diet and exercise).

We sent a shadow shopper to 30 different pharmacies in the Sydney metropolitan area over four days in December 2006, and asked her to buy Xenical in each one.

About our shadow shopper

Age: A young-looking 19-year-old girl

Height: 168cm

Weight: 70kg

BMI: 24.8

Diet: Healthy diet of meat, fruit and vegetables, rarely eats takeaway food.

Exercise: Walks three to four hours a week, and swims regularly.

Occupation: Full-time student, employed part-time as a lifeguard at a swimming centre.

Health: No obesity co-morbidities (such as diabetes, high blood pressure).

Xenical suitability: Xenical isn't appropriate for her, according to Pharmaceutical Society of Australia (PSA) guidelines.

What we found

Our shadow shopper was sold Xenical in 24 (80%) of the 30 pharmacies visited. This clearly demonstrated that many pharmacists weren't following PSA guidelines and were supplying the drug inappropriately. Here are the details:

• Less than one third of the pharmacies measured or asked for her height and weight. These details are needed to calculate BMI, which should be considered before supplying Xenical.
• Her BMI was calculated in just nine pharmacies (in one of these she had to do the calculation herself). Three of these pharmacies went on to sell her Xenical.
• Two correctly calculated her BMI as 25, but sold Xenical to her anyway. The third incorrectly calculated her BMI as 27 (using her height and weight measurements, which she gave them) and sold her the drug.
• No-one measured or asked for her waist circumference.
• No-one confirmed our shopper's age (even though the safety and effectiveness of Xenical in children hasn't been established, so it's not recommended to children or adolescents under 18 years of age).
• On several occasions the pharmacy commented to our shadow shopper that she didn't need Xenical, but sold it to her regardless.

In the 24 pharmacies where she was sold Xenical:

• Eight gave no directions on how to use the product, and of the 16 who did, the explanations were brief.
• Only 13 gave her some counselling or advice about diet and exercise when taking the drug.
• Side-effects of Xenical were mentioned in just 16 pharmacies.

We care about accuracy. See something that's not quite right in this article? Let us know or read more about fact-checking at CHOICE.

Stock images: Getty, unless otherwise stated.

Success accompanies professionals. Trademark "Xenical" - the absolute Favorite of Success in the Ukrainian market

In December 2006, the winners of the "Favorites of Success" competition of the year, held among brands, companies, executives and famous people of Ukraine, were announced. The winners were determined using the "Formula of Success" professional methodology based on an independent study, including the assessment of Professional Experts, a Jury of Successful People (celebrities) and Consumers. In the nomination "OTC Pharmaceuticals" among the means for weight loss, the absolute winner of 2006 was the trademark "Xenical". The criteria by which goods in this nomination were evaluated are very different. The quality of the product, the price/quality ratio, the convenience and attractiveness of the packaging, the marketing and distribution system, the promotion and success of the product were taken into account. The results of the competition have been verified by the Kyiv International Institute of Sociology, which guarantees its objectivity and transparency.

There is every reason to believe that the victory of this brand is not accidental.

XENICAL (orlistat), developed by the well-known Swiss company F. Hoffmann-La Roche Ltd, has been on the world market since 1999. Today it is one of the most effective and safe drugs used in the treatment of obesity. The data of experimental scientific studies conducted in recent years testify in favor of the possible use of XENICAL not only as a means to reduce body weight. Presumably, orlistat can be used in the treatment of other serious diseases. But before talking about the prospects, let's dwell on the problem that this high-quality modern drug is already helping to solve.

Obesity is now spoken of as an epidemic disease in some countries. If earlier this problem was considered mainly at the level of highly developed countries, now it has become almost equally relevant for developing countries due to the increase in their urbanization rates. According to WHO forecasts ( www.who.intrel="nofollow" target="_blank"> ), by 2015 about 2. 3 billion adults in the world will be overweight and more than 700 million obese. In Ukraine, by this time, the spread of the disease is expected in women under 19.4% and in men up to 7.4%. It would seem that the situation is not as serious as in the USA, where 60.3% of women and 57.2% of men are predicted to have obesity by 2015, and today they are developing and implementing state programs to combat overweight. Nevertheless, domestic specialists are increasingly faced with the presence of diseases in patients, the successful treatment of which is possible only with the normalization of body weight.

Often the main cause of obesity is an imbalance between the number of calories received and consumed by the body. What factors contribute to the energy imbalance in a significant part of the population around the world? It is customary to distinguish two of the most important of them:

• a global change in nutrition, including the consumption of energy-intensive food with high sugar content and insufficient vitamins;
• decrease in physical activity due to the peculiarities of modern working conditions, global urbanization leading to unreasonably frequent use of transport, etc.

• In addition to the fact that overweight and obesity in themselves lead to a decrease in the patient's socioeconomic status, they lead to the development of a number of comorbidities and complications that significantly aggravate the situation. The metabolic and endocrine effects of obesity trigger the mechanisms of occurrence, primarily of cardiovascular diseases, which rank first in the world in the structure of causes of death. The next serious complication is diabetes mellitus, which is also gaining epidemic proportions. A significant proportion is musculoskeletal pathology (especially osteoarthritis) and some types of cancer (endometrial, breast, colon cancer).

  The accumulated experience and repeated studies of specialists in this field indicate that all the proposed measures aimed at eliminating the energy imbalance can only be considered preventive. In chronic obesity, it is difficult, and often impossible, to achieve optimal and sustainable weight loss by eliminating certain types of foods and increasing physical activity. In such cases, an important component of therapy to improve the quality of life of patients with obesity is the pharmacotherapy of the disease.

  XENICAL: loss of excess body weight during therapy, persistent effect after its end, clinically proven slowing of body weight gain within 2 years after the end of the course of the drug, safety, presence of additional clinical successes

  Ideal drugs used to reduce excess body weight should have a number of important characteristics (Raj S. Padwal, Sumit R. Majumdar, 2007):

  • firstly, they should contribute to clinically significant weight loss and reduce the risk of obesity-related diseases;
  • secondly, the benefit / risk ratio in their application should be optimal.

  A 5-10% reduction in body weight from baseline has been shown to be clinically significant, resulting in a reduced risk of type II diabetes and other complications.

  Let's consider XENICAL from this point of view, which in the past year won the highest rating not only from consumers, but also from professional experts. Being a specific inhibitor of gastrointestinal lipases, the drug promotes the excretion of about 30% of dietary fats from the body. This effect is achieved due to the fact that the breakdown of a significant amount of triglycerides from food into free fatty acids and monoglycerides is blocked.

  Studies to study the efficacy, safety and additional pharmacokinetic properties of XENICAL have been conducted by reputable experts for several years and are ongoing.

  In a multicenter randomized parallel study (X-PERT) of two groups of patients from 23 clinical centers in different countries (Austria, Germany, Belgium, Canada, Brazil, France, Switzerland, Mexico, Australia), the results of orlistat in combination with an energy-reduced diet were analyzed (minus 500 kcal/day — group I and minus 1000 kcal/day — group II) (Toplak H. , Ziegler O. et al., 2005).

  Patients who noted a decrease in body weight by 5% or more for 3 and then 6 months were admitted to the full study within a year.

  In these patients, the most significant decrease in body weight occurred in the first 4 weeks - about 4 kg in both groups (Fig. 1). A further decrease in body weight (about 2 kg) was noted at 4–8 weeks, then at 8–12 weeks. It was also approximately the same (minus 11.4 kg ± 6.2 kg in group I and minus 11.8 ± 7.1 kg in group II) after 12 months of treatment with orlistat 120 mg 3 times a day during meals in combination with diet: body weight decreased by 5% or more in 84% of patients in group I and 85% in group II. Half of the patients showed a decrease in body weight by 10% or more. In 23% of patients of group I and 21% of group II, a decrease in body weight by 15% or more was noted (Fig. 2).

  Fig. 1. Weight loss in obese patients treated with orlistat in combination with two types of low-calorie diet for 12 months

  Fig. 2. Number of patients (%) whose body weight decreased by ≥5, ≥10, ≥15, ≥20% within 12 months when treated with orlistat in combination with a hypocaloric diet

  In many studies, it is very important to obtain clinically significant results in lowering blood pressure with orlistat treatment. In the X-PERT study, patients with systolic (≥140 mmHg) or diastolic (≥90 mmHg Art. ) hypertension pressure decreased by an average of 17.1 and 8.9 mm Hg. Art. respectively in group I and 19 and 10.9 mm Hg. Art. in II. In addition, the level of total cholesterol in the blood of patients decreased by 6.3% in group I and by 7.3% in group II.

  Thus, it can be stated that the difference between the two groups of patients in terms of weight loss and changes in other indicators is insignificant, which indicates in favor of the dominance of the effect of orlistat treatment over the effect of an energy-reduced diet. The same experts refer to meta-analyses of five randomized placebo-controlled trials, according to which weight loss in the treatment of orlistat is associated with a decrease in blood pressure, blood cholesterol levels, fasting blood glucose levels, and a reduced risk of developing type II diabetes mellitus.

  The use of XENICAL reduces: serum triglyceride level serum cholesterol level fasting blood glucose risk of type II diabetes mellitus risk of developing arterial hypertension

  According to a meta-analysis of 11 placebo-controlled studies conducted within one year with the participation of 6021 overweight and obese patients, the use of orlistat contributed to a decrease in body weight by 2-9% of baseline (Raj S. Padwal, Sumit R. Majumdar, 2007). The data from this recent study also support additional clinical successes with the drug. These properties make it possible to reduce the dose of drugs intended for the treatment of arterial hypertension, as well as oral hypoglycemic agents. In Europe and the United States, experts recommend prescribing orlistat to patients not only to reduce excess body weight, but also as an additional agent in the treatment of type II diabetes mellitus, chronic arterial hypertension, and high blood cholesterol.

  It is known that in the treatment of obesity and overweight, the ability to maintain the results achieved during therapy is very important. It was for this disease that the urgent problem was the frequent return after a short period to the initial data, that is, to the state prior to treatment. Patients who have repeatedly tried to get rid of excess weight know how short-lived success is and how quickly “lost” kilograms return. What do the data of clinical trials with respect to XENICAL indicate about this? The authors of the X-PERT study present the results of two multicenter randomized trials of overweight and obese patients. Upon completion, patients who lost weight ≥5% during the first 3 months of treatment showed an improvement in the next 2 years in terms of maintaining body weight and normalizing the main risk factors.

  So, there are full authoritative and repeated confirmations of the compliance of XENICAL with the most important requirements for drugs for weight loss by specialists. A few words should be added about the safety of the drug as another selection criterion in the pharmacotherapy of obesity.

  Intestinal complications identified in control groups in various scientific studies are characterized as minor: with an excess fat content in the diet, phenomena such as loose stools and steatorrhea may occur. However, these effects are easily eliminated by following a low-fat diet, which is taken into account when prescribing XENICAL to patients. Cautious use of the drug is recommended for certain intestinal diseases, in particular, chronic diarrhea. The safety of orlistat is determined primarily by its negligible absorption capacity and the maximum concentration of the active ingredient in the intestines, but not in the blood, which excludes the occurrence of serious systemic complications.

  On February 7, 2007, the U.S. Food and Drug Administration (FDA) issued an OTC approval for orlistat.

  Earlier, on May 18, 2005, F. Hoffmann-La Roche Ltd announced that XENICAL has been approved by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) for use in overweight adolescents in aged 12 years and over. This allowed European countries to include new data on its use in the instructions for the drug. The changes made to the instructions are based on data obtained in large-scale placebo-controlled studies. Their results were announced at the International Congress on Obesity in Sydney (Australia). In adolescents who received a course of treatment with XENICAL in combination with a diet, a significant decrease in body mass index was noted compared with patients who received placebo. At the same time, the best results were found in the group of patients who, after 12 weeks of treatment, had a decrease in body weight by ≥5%. In them, as in adults, taking XENICAL was well tolerated.

  This year, it is planned to make a corresponding change to the instructions for using the drug in Ukraine. This will expand the capabilities of domestic medicine in the fight against childhood obesity, the trend of increasing incidence of which has been noted in our country for more than a year.

  Of course, the approval of the use of orlistat by such authoritative organizations as the FDA and the European Commission once again testifies in favor of the effectiveness and safety of the drug.

  Experimental results of the use of the drug in oncology also testify to the unique prospects of XENICAL. According to these data, orlistat has an antitumor effect against tumor cells of breast and prostate cancer, colorectal cancer (Krider S. J. et al., 2004), ovarian cancer (Menendez J.A. et al., 2006), inhibits overexpression and induces apoptosis of highly metastatic cell lines stomach cancer (Menendez J.A. et al., 2005). The suppressive effect on tumor cells is due to the blocking of the mechanisms of activity of fatty acid synthetase (FAS) by direct inhibition of the thioesterase domain of FAS. Orlistat has a minimal effect on normal (non-tumor) cells.

  Assignment of XENICAL to new indications, including oncological ones, and the development of its new dosage form with high bioavailability is a matter of the future. Today, the drug has won the trust of patients, doctors and professional experts as an effective drug for reducing overweight, treating obesity and related diseases. about

  Natalya Ocheretyanaya.
  Photo provided by the representative office of Hoffmann-La Roche Ltd in Ukraine

Xenical, Xenical

Active substance: orlistat (orlistat)

Clinical and pharmacological group: Drug for the treatment of obesity - inhibitor of gastrointestinal lipases

Pharmacotherapeutic group: Gastrointestinal lipase inhibitor

Pharmacological action

Xenical is a potent, specific and reversible inhibitor of gastrointestinal lipases with a long-lasting effect. Its therapeutic effect is carried out in the lumen of the stomach and small intestine and consists in the formation of a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme loses its ability to break down dietary fats in the form of triglycerides into absorbable free fatty acids and monoglycerides. Because undigested triglycerides are not absorbed, the resulting decrease in calorie intake leads to weight loss. Thus, the therapeutic effect of the drug is carried out without absorption into the systemic circulation.

Based on faecal fat content, orlistat's effects begin 24-48 hours after ingestion. After discontinuation of the drug, the fat content in the feces after 48-72 hours usually returns to the level that occurred before the start of therapy.

Efficacy

Obese patients

In clinical studies, patients taking orlistat experienced greater weight loss compared to patients on diet therapy. Weight loss began already within the first 2 weeks after the start of treatment and lasted from 6 to 12 months, even in patients with a negative response to diet therapy. Over the course of 2 years, there was a statistically significant improvement in the profile of metabolic risk factors associated with obesity. In addition, compared with placebo, there was a significant reduction in body fat. Orlistat is effective in preventing re-gain of body weight. Re-gaining body weight, no more than 25% of the lost, was observed in about half of the patients, and in half of these patients, re-gaining body weight was not observed or even a further decrease was noted. 9orlistat diet therapy alone. Weight loss occurred mainly due to a decrease in the amount of fat in the body. It should be noted that before the start of the study, despite the use of hypoglycemic agents, patients often had insufficient glycemic control. However, with orlistat therapy, a statistically and clinically significant improvement in glycemic control was observed. In addition, against the background of orlistat therapy, a decrease in doses of hypoglycemic agents, insulin concentrations, and a decrease in insulin resistance were observed.

Reduced risk of developing type 2 diabetes in obese patients

In a 4-year clinical trial, orlistat was shown to significantly reduce the risk of developing type 2 diabetes (approximately 37% compared with placebo). The rate of risk reduction was even greater in patients with baseline glucose intolerance (approximately 45%). The orlistat group experienced more significant weight loss compared to the placebo group. Maintenance of body weight at a new level was observed throughout the entire study period. Moreover, compared with placebo, patients treated with orlistat showed a significant improvement in their metabolic risk factor profile.

Pubertal obesity

In a 1-year clinical study in obese adolescents, a decrease in body mass index was observed when taking orlistat compared with a placebo group, where there was even an increase in body mass index. In addition, patients in the orlistat group showed a decrease in fat mass, as well as waist and hip circumference, compared with the placebo group. Also, in patients treated with orlistat therapy, there was a significant decrease in diastolic blood pressure compared with the placebo group.

Preclinical safety data

No additional risks to patients in terms of safety profile, toxicity, genotoxicity, carcinogenicity and reproductive toxicity have been identified based on preclinical data. Animal studies have also shown no teratogenic effect. Due to the absence of a teratogenic effect in animals, it is unlikely to be detected in humans.

Pharmacokinetics

Absorption

In normal weight and obese volunteers, systemic exposure to the drug is minimal. After a single oral dose of the drug at a dose of 360 mg, unchanged orlistat in plasma could not be determined, which means that its concentrations are below the level of 5 ng / ml.

In general, after taking therapeutic doses, it was possible to detect unchanged orlistat in plasma only in rare cases, while its concentrations were extremely low (<10 ng / ml or 0. 02 μmol). There were no signs of cumulation, which confirms that the absorption of the drug is minimal.

Distribution

Vd cannot be determined because the drug is very poorly absorbed. In vitro, orlistat is more than 99% bound to plasma proteins (mainly lipoproteins and albumin). In minimal amounts, orlistat can penetrate red blood cells.

Metabolism

Based on animal data, orlistat metabolism occurs primarily in the intestinal wall. In a study in obese individuals, it was found that approximately 42% of the minimum fraction of the drug that undergoes systemic absorption falls on the two main metabolites - M1 (four-membered hydrolyzed lactone ring) and M3 (M1 with a cleaved N-formilleucine residue).

Molecules M1 and M3 have an open b-lactone ring and inhibit lipase extremely weakly (respectively, 1000 and 2500 times weaker than orlistat). Given this low inhibitory activity and low plasma concentrations (average 26 ng/mL and 108 ng/mL, respectively) following therapeutic doses, these metabolites are considered to be pharmacologically inactive.

Elimination

Studies in normal and overweight subjects have shown that the main route of elimination is excretion of unabsorbed drug in the feces. Approximately 97% of the administered dose was excreted in the faeces, with 83% being excreted as unchanged orlistat.

Cumulative renal excretion of all substances structurally related to orlistat is less than 2% of the administered dose. The time to complete elimination of the drug from the body (with feces and urine) is 3-5 days. The ratio of orlistat excretion pathways in volunteers with normal and overweight was the same. Both orlistat and the metabolites M1 and M3 may be excreted in the bile.

Pharmacokinetics in special clinical groups

Plasma concentrations of orlistat and its metabolites (M1 and M3) in children do not differ from those in adults when comparing the same doses of the drug. The daily excretion of fat in the feces was 27% of the intake with food with orlistat therapy and 7% with placebo.

Indications for Xenical®

• long-term therapy in obese or overweight patients, incl. having obesity-associated risk factors, in combination with a moderately low-calorie diet;
• in combination with hypoglycemic drugs (metformin, sulfonylurea derivatives and / or insulin) or a moderately hypocaloric diet in overweight or obese patients with type 2 diabetes.

You can order Xenical on our website, and our specialists will advise you on the terms of payment and delivery to your city

Dosing regimen risk factors, in combination with a moderately hypocaloric diet in adults and children over 12 years of age, the recommended dose of orlistat is one 120 mg capsule with each main meal (during meals or no later than one hour after meals).

In combination with hypoglycemic drugs (metformin, sulfonylurea derivatives and/or insulin) or a moderately hypocaloric diet in patients with type 2 diabetes who are overweight or obese: in adults the recommended dose of orlistat is one 120 mg capsule with each main meal (during a meal or no later than an hour after a meal).

If a meal is skipped or if the meal does not contain fat, Xenical can also be skipped.

The drug should be taken in combination with a balanced, moderately hypocaloric diet containing no more than 30% of calories in the form of fat. The daily intake of fats, carbohydrates and proteins must be divided into three main meals.

An increase in the dose of orlistat above the recommended one (120 mg 3 times / day) does not lead to an increase in its therapeutic effect.

The safety and efficacy of Xenical in patients with impaired hepatic and/or renal function, and in elderly and pediatric patients (under 12 years of age) have not been studied.

Side effects

Clinical data

The following categories are used to describe the frequency of adverse reactions: very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, < 1/100), rare (≥1/10000, <1/1000) and very rare (<1/10000), including individual cases.

Adverse reactions to orlistat occurred mainly from the gastrointestinal tract and were due to the pharmacological action of the drug, which prevents the absorption of dietary fat. Very often there were such phenomena as oily discharge from the rectum, gas with some discharge, imperative urge to defecate, steatorrhea, increased defecation, loose stools, flatulence, pain or discomfort in the abdomen.

Their frequency increases with increasing fat content in the diet. Patients should be informed about the possibility of adverse reactions from the gastrointestinal tract and taught how to eliminate them by better dietary compliance, especially in relation to the amount of fat contained in it. The use of a low-fat diet reduces the likelihood of gastrointestinal side effects and thus helps patients control and regulate their fat intake.

As a rule, these adverse reactions are mild and transient. They occurred in the early stages of treatment (in the first 3 months), and most patients had no more than one episode of such reactions.

Gastrointestinal side effects that are common during treatment with Xenical include soft stools, rectal pain or discomfort, fecal incontinence, bloating, tooth damage, and gum disease.

Also very common: headaches, upper respiratory infections, influenza; often: lower respiratory tract infections, urinary tract infections, dysmenorrhea, anxiety, weakness.

In patients with type 2 diabetes, the nature and frequency of adverse events were comparable to those in patients without diabetes who were overweight and obese. The only new side effects in patients with type 2 diabetes were hypoglycemic conditions, which occurred with a frequency of >2% and an incidence of ≥1% compared with placebo (which could result from improved carbohydrate metabolism compensation), and often - bloating.

In the 4-year clinical study, the overall safety profile did not differ from that obtained in the 1- and 2-year studies. At the same time, the overall incidence of adverse events from the gastrointestinal tract decreased annually over a 4-year period of taking the drug.

Post-marketing surveillance

Rare cases of allergic reactions have been described, the main clinical symptoms of which were pruritus, rash, urticaria, angioedema, bronchospasm and anaphylaxis.

Very rare cases of bullous rash, increased activity of transaminases and alkaline phosphatase, as well as isolated, possibly serious, cases of hepatitis have been described (causal relationship with Xenical® or pathophysiological mechanisms of development have not been established).

With the simultaneous administration of Xenical and anticoagulants, there have been cases of a decrease in prothrombin, an increase in the values ​​of the international normalized ratio (INR) and unbalanced anticoagulant therapy, which led to a change in hemostatic parameters.

Cases of rectal bleeding, diverticulitis, pancreatitis, cholelithiasis and oxalate nephropathy have been reported (frequency unknown).

With the simultaneous use of orlistat and antiepileptic drugs, cases of seizures were observed (see section "Interaction with other drugs").

Contraindications for use

• chronic malabsorption syndrome;
• cholestasis;
• hypersensitivity to the drug or any other components contained in the capsule.

Use in pregnancy and lactation

Category B product. In the absence of a teratogenic effect in animals, a similar effect in humans should not be expected. However, due to the lack of clinical data, Xenical should not be given to pregnant women.

Excretion of orlistat in breast milk has not been studied, so it should not be taken during breastfeeding.

Special instructions

Xenical is effective in long-term weight control (weight loss and maintenance at a new level, prevention of re-gain of body weight). Treatment with Xenical leads to an improvement in the profile of risk factors and diseases associated with obesity, including hypercholesterolemia, type 2 diabetes mellitus, impaired glucose tolerance, hyperinsulinemia, arterial hypertension, and to a decrease in visceral fat.

When used in combination with hypoglycemic drugs such as metformin, sulfonylurea derivatives and/or insulin in patients with type 2 diabetes mellitus who are overweight (body mass index (BMI) ≥28 kg/m2) or obese (BMI ≥30 kg / m2), Xenical in combination with a moderately hypocaloric diet provides an additional improvement in the compensation of carbohydrate metabolism.

In clinical studies, most patients had vitamin A, D, E, K and betacarotene concentrations within the normal range during four years of orlistat therapy. A multivitamin may be prescribed to ensure adequate intake of all nutrients.

The patient should receive a balanced, moderately hypocaloric diet containing no more than 30% of calories as fat. A diet rich in fruits and vegetables is recommended. The daily intake of fats, carbohydrates and proteins must be divided into three main meals.

The likelihood of adverse reactions from the gastrointestinal tract may increase if Xenical is taken on the background of a diet rich in fats (for example, 2000 kcal / day, of which more than 30% are in the form of fat, which equals approximately 67 g of fat). Daily fat intake should be divided into three main meals. If Xenical is taken with a meal that is very rich in fat, the likelihood of gastrointestinal reactions is increased.

In patients with type 2 diabetes, weight loss during treatment with Xenical is accompanied by improved carbohydrate metabolism compensation, which may allow or require a reduction in the dose of hypoglycemic drugs (eg, sulfonylurea derivatives).

Overdose

In clinical studies in subjects with normal body weight and obese patients, single doses of 800 mg or multiple doses of 400 mg 3 times / day for 15 days were not accompanied by the appearance of significant adverse events. In addition, obese patients have experience with the use of orlistat 240 mg 3 times / day for 6 months, which was not accompanied by a significant increase in the frequency of adverse events.

In cases of overdose of Xenical, either no adverse events were reported, or adverse events did not differ from those observed when taking the drug at therapeutic doses.

In the event of a severe overdose of Xenical, it is recommended to observe the patient for 24 hours. Based on human and animal studies, any systemic effects that could be associated with the lipase-inhibiting properties of orlistat should be rapidly reversible.

Drug interactions

No interactions with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, oral contraceptives, phentermine, pravastatin, warfarin, nifedipine sibutramine or alcohol (based on drug interaction studies). However, it is necessary to monitor the INR indicators during concomitant therapy with warfarin or other oral anticoagulants.

When taken simultaneously with Xenical, there was a decrease in the absorption of vitamins D, E and betacarotene. If multivitamins are recommended, they should be taken at least 2 hours after taking Xenical or at bedtime.

Co-administration of Xenical and ciclosporin has been associated with a decrease in plasma ciclosporin concentrations, therefore more frequent determination of plasma ciclosporin concentrations is recommended while taking ciclosporin and Xenical.

With oral administration of amiodarone during therapy with Xenical, a decrease in the systemic exposure of amiodarone and deethylamiodarone (by 25-30%) was noted, however, due to the complex pharmacokinetics of amiodarone, the clinical significance of this phenomenon is not clear. The addition of Xenical to long-term amiodarone therapy may reduce the therapeutic effect of amiodarone (no studies have been conducted).

Co-administration of Xenical and acarbose should be avoided due to lack of pharmacokinetic data.

Concurrent use of orlistat and antiepileptic drugs has been associated with seizures. A causal relationship between the development of seizures and orlistat therapy has not been established. However, patients should be monitored for possible changes in the frequency and/or severity of seizures.

Storage conditions of the drug Xenical®

The drug should be stored at a temperature not exceeding 25 ° C in a place protected from moisture, out of the reach of children.

Shelf life of Xenical®

Shelf life - 3 years. Do not use after the expiry date stated on the packaging.

Terms of sale

The drug is dispensed by prescription.

To place an order, fill out the form and send it to e-mail [email protected]

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