Odistad 120 Special Precautions

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.