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  • Xenical
    / Tzamal

    Active Ingredient
    Orlistat 120 mg

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft


    84 X 120 mg

    not in the basket chart 51546 24022

    Related information


    Adults and children from 12 years of age: 1 capsule 3 x daily. Should be taken with water immediately before, during or up to one hour after each main meal. 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. See prescribing information for full details. The effect in patients with hepatic and/or renal impairment, children and elderly patients has not been studied.

    recommended drugs


    Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m² or overweight patients (BMI > 28 kg/m? with associated risk factors. Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5 % of the body weight as measured at the start of therapy.


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

    Special Precautions

    Antidiabetic drug treatment may have to be closely monitored, The possibility of experiencing gastrointestinal adverse reactions may increase when it is taken with a diet high in fat, coagulation parameters should be monitored in patients treated with concomitant oral anticoagulants, may potentially impair the absorption of fat-soluble vitamins (ADEK), organic causes of obesity should be excluded before prescribing orlistat, history of hyperoxaluria or calcium oxalate nephrolithiasis, orlistat may unbalance anticonvulsivant treatment by decreasing the absorption of antiepileptic drugs, leading to convulsions.
    See prescribing information for full details.

    Side Effects

    Headache, Upper respiratory infection, Rectal pain, discomfort, Soft stools, Faecal incontinence, Abdominal distension, Tooth disorder, Gingival disorder, Urinary tract infection, Hypoglycemia, Influenza, Fatigue, Menstrual irregularity, Anxiety.
    See prescribing information for full details.

    Drug interactions

    Ciclosporin: 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. This can lead to a decrease of immunosuppressive efficacy. Therefore the combination is not recommended. 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. Ciclosporin blood levels should be monitored until stabilized.
    Acarbose: In the absence of pharmacokinetic interaction studies, the concomitant administration of Orlistat with acarbose should be avoided.
    Oral anticoagulants: When warfarin or other anticoagulants are given in combination with Orlistat, international normalized ratio (INR) values should be monitored.
    Fat soluble vitamins: Treatment with Orlistat may potentially impair the absorption of fat-soluble vitamins (A, D, E and K). The vast majority of patients receiving up to four full years of treatment with Orlistat in clinical studies had vitamin A, D, E and K and beta-carotene levels that stayed within normal range. 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. If a multivitamin supplement is recommended, it should be taken at least two hours after the administration of Orlistat or at bedtime.
    Amiodarone: A slight decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received Orlistat concomitantly. In patients receiving amiodarone treatment, the clinical relevance of this effect remains unknown but may become clinically relevant in some cases. In patients receiving concomitant amiodarone treatment, reinforcement of clinical and ECG monitoring is warranted. Convulsions have been reported in patients treated concomitantly with Orlistat and antiepileptic drugs e.g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded. 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. The mechanism, although not proven, may involve a decreased absorption of iodine salts and/or levothyroxine .
    There are some case reports of reduced efficacy of of antiretroviral HIV medicines, antidepressants and antipsychotics (including lithium) coincidental to the initiation of Orlistat treatment in previously well-controlled patients. Therefore Orlistat treatment should only be initiated after careful consideration of the possible impact in these patients.
    See prescribing information for full details.

    Pregnancy and Lactation

    Pregnancy: For Orlistat no clinical data on exposed pregnancies are available.
    Breasfeeding:  As it is not known whether Orlistat is secreted into human milk, Orlistat is contra-indicated during breast-feeding.
    See prescribing information for full details.


    Single doses of 800 mg Orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings. In addition, doses of 240 mg tid have been administered to obese patients for 6 months. The majority of Orlistat overdose cases received during post-marketing reported either no adverse events or adverse events that are similar to those reported with recommended dose.
    Should a significant overdose of Orlistat occur, it is recommended that the patient be observed for 24 hours. Based on human and animal studies, any systemic effects attributable to the lipase-inhibiting properties of Orlistat should be rapidly reversible.