Each capsule contains Orlistat 60 mg or 120 mg.
Excipients/Inactive Ingredients: Microcrystalline cellulose, Povidone, Colloidal silicon dioxide, Sodium starch glycolate, Sodium Lauryl Sulfate, Tocopheryl Acetate, Polyethylene Glycol, Polyoxyl 40 Hydrogenated Caster oil, Talc, Magnesium Stearate.
60 mg cap: Zerotex is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥ 28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.
120 mg cap: Zerotex 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/m2) 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.
Posology: 60 mg cap: Adults: The recommended dose of Zerotex is one 60 mg capsule to be taken three times daily. No more than three 60 mg capsules should be taken in 24 hours.
Diet and exercise are important parts of a weight loss programme. It is recommended that a diet and exercise programme is started before beginning treatment with Zerotex.
While taking orlistat, the patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat (e.g. in a 2,000 kcal/day diet, this equates to <67 g of fat). The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
The diet and exercise programme should continue to be followed when treatment with Zerotex is stopped.
Treatment should not exceed 6 months.
If patients have been unable to lose weight after 12 weeks of treatment with Zerotex, they should consult their doctor or a pharmacist. It may be necessary to discontinue treatment.
120 mg cap: 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 Zerotex in children.
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.
Hypersensitivity to the active substance or to any of the excipients; Chronic malabsorption syndrome; Cholestasis; Breast-feeding; Pregnancy.
60 mg cap: The use of Orlistat may cause severe liver injury.
Do not take in case of pregnancy.
If the patient has kidney disease, consult the doctor before use.
Do not take more than 3 capsules a day.
120 mg cap: 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.
Co-administration of orlistat with ciclosporin is not recommended.
Patients should be advised to adhere to the dietary recommendations they are given.
The possibility of experiencing gastrointestinal adverse reactions may increase when orlistat is taken with a diet high in fat (e.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 Zerotex. Prescribers should investigate further in case of severe and/or persistent symptoms.
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea.
Coagulation parameters should be monitored in patients treated with concomitant oral anticoagulants. Some patients may develop increased levels of urinary oxalate following treatment with Zerotex. Cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported. Monitor renal function when prescribing Zerotex to patients at risk for renal impairment and use with caution in those with a history of hyperoxaluria or calcium oxalate nephrolithiasis.
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.
Antiepileptics patient: Orlistat may unbalance anticonvulsivant treatment by decreasing the absorption of antiepileptic drugs, leading to convulsions.
There have been rare postmarketing reports of severe liver injury with hepatocellular necrosis or acute hepatic failure in patients treated with Zerotex, with some of these cases resulting in liver transplant or death. Patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light-colored stools, or right upper quadrant pain) while taking Zerotex. When these symptoms occur, Zerotex and other suspect medications should be discontinued immediately and liver function tests and ALT and AST levels obtained.
Effects on ability to drive and use machines: Zerotex has no influence on the ability to drive and use machines.
Zerotex is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy. No embryotoxicity or teratogenicity was seen in animals that received orlistat at doses much higher than the recommended human dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard of maternal weight loss to the fetus.
It is not known if Zerotex is present in human milk. Caution should be exercised when Zerotex is administered to a nursing woman.
Adverse reactions to orlistat are largely gastrointestinal in nature. The incidence of adverse events decreased with prolonged use of orlistat.
Adverse events are listed as follows 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: See Table 1.
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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.
The following table of undesirable effects is based on post-marketing spontaneous reports, and therefore the frequency remains unknown: See Table 2.
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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 stabilised.
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 normalised 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.
Lack of interactions: No interactions with amitriptyline, atorvastatin, biguanides, digoxin, fibrates, fluoxetine, losartan, phenytoin, phentermine, pravastatin, nifedipine Gastrointestinal Therapeutic System (GITS), nifedipine slow release, sibutramine or alcohol have been observed. 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. However, orlistat may indirectly reduce the availability of oral contraceptives and lead to unexpected pregnancies in some individual cases. An additional contraceptive method is recommended in case of severe diarrhoea.
A08AB01 - orlistat ; Belongs to the class of peripherally acting antiobesity products.
60 mg: P1; 120 mg: P1S1S3
Zerotex cap 120 mg
21's;84's
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