Xenical

Adults The recommended dose of orlistat is one 120 mg capsule taken with water immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted. The patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30 % of calories from fat.

It is recommended that the diet should be rich in fruit and vegetables. The daily intake of fat, carbohydrate and protein should be distributed over three main meals. Doses of orlistat above 120 mg three times daily have not been shown to provide additional benefit.

The effect of orlistat results in an increase in faecal fat as early as 24 to 48 hours after dosing. Upon discontinuation of therapy, faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours. Special populations The effect of orlistat in patients with hepatic and/or renal impairment, children and elderly patients has not been studied.

There is no relevant indication for use of Xenical in children.

Adverse reactions to orlistat are largely gastrointestinal in nature. The incidence of adverse events decreased with prolonged use of orlistat. Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000) including isolated reports.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. The following table of undesirable effects (first year of treatment) is based on adverse events that occurred at a frequency of > 2 % and with an incidence ≥ 1 % above placebo in clinical trials of 1 and 2 years duration: 6 System organ class Adverse reaction/event Nervous system disorders Very common: Headache Respiratory, thoracic and mediastinal disorders Very common: Common: Upper respiratory infection Lower respiratory infection Gastrointestinal disorders Very common: Common: Abdominal pain/discomfort Oily spotting from the rectum Flatus with discharge Faecal urgency Fatty/oily stool Flatulence Liquid stools Oily evacuation Increased defecation Rectal pain/discomfort Soft stools Faecal incontinence Abdominal distension* Tooth disorder Gingival disorder Renal and urinary disorders Common: Urinary tract infection Metabolism and nutrition disorders Very common: Hypoglycemia* Infections and infestations Very common: Influenza General disorders and administration site conditions Common: Fatigue Reproductive system and breast disorders Common: Menstrual irregularity Psychiatric disorders Common: Anxiety * only unique treatment adverse events that occurred at a frequency of > 2 % and with an incidence ≥ 1 % above placebo in obese type 2 diabetic patients.

In a 4 year clinical trial, the general pattern of adverse event distribution 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 year on year over the four year period.

In clinical trials, the decrease in bodyweight with orlistat treatment was less in type II diabetic patients than in non-diabetic patients. Antidiabetic medicinal product treatment may have to be closely monitored when taking orlistat.

5). 2). g. in a 2000 kcal/day diet, > 30 % of calories from fat equates to > 67 g of fat). The daily intake of fat should be distributed over three main meals. If orlistat is taken with a meal very high in fat, the possibility of gastrointestinal adverse reactions may increase.

Cases of rectal bleeding have been reported with Xenical. Prescribers should investigate further in case of severe and/or persistent symptoms. 5). 8). The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy leading sometimes to renal failure.

8). Rare occurrence of hypothyroidism and/or reduced control of hypothyroidism may occur. 5). 5). 5). This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

Hypersensitivity to the active substance or to any of the excipients. - Chronic malabsorption syndrome. - Cholestasis. - Breast-feeding. 3