Active ingredient: Orlistat (as orlistat pellets) 120 mg.
Excipients/Inactive Ingredients: Component of pellets: Low-substituted hydroxypropyl cellulose, starch, sodium lauryl sulfate, sodium carboxymethyl starch, povidone, talc.
Component of empty capsule: FD&C blue 1, FD&C red 3, titanium dioxide, gelatin, printing ink.
Component of printing ink (WHITE SB-0007P): Shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, sodium hydroxide, povidone, titanium dioxide.
Orlistat 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.
Dosage: 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 orlistat in children.
Administration: For oral use.
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; Pregnancy and breast-feeding.
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 orlistat. 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.
The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy leading sometimes to renal failure. This risk is increased in patients with underlying chronic kidney disease and/or volume depletion.
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 anticonvulsant treatment by decreasing the absorption of antiepileptic drugs, leading to convulsions.
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.
Severe liver injury with the use of orlistat.
Increases in urinary oxalate. Some patients may develop increased levels of urinary oxalate following treatment with Odistad 120 capsules. Cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported. Monitor renal function when prescribing Odistad 120 capsules to patients at risk for renal impairment and use with caution in those with a history of hyperoxaluria or calcium oxalate nephrolithiasis.
Effects on ability to drive and use machines: Orlistat has no influence on the ability to drive and use machines.
Pregnancy: For orlistat no clinical data on exposed pregnancies are available.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Orlistat is contraindicated during pregnancy.
Lactation: As it is not known whether orlistat is secreted into human milk, orlistat is contraindicated during breast-feeding.
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).
Nervous system disorders: Very common: Headache.
Respiratory, thoracic and mediastinal disorders: Very common: Upper respiratory infection; Common: Lower respiratory infection.
Gastrointestinal disorders: Very common: Abdominal pain/discomfort, oily spotting from the rectum, flatus with discharge, faecal urgency, fatty/oily stool, flatulence, liquid stools, oily evacuation, increased defecation; Common: 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.)
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.
There are some case reports of reduced efficacy 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.
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.
Store in a well-closed container, in a dry place. Do not store above 30°C.
A08AB01 - orlistat ; Belongs to the class of peripherally acting antiobesity products.
Odistad 120 cap 120 mg
1 × 42's
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