Zerotex Special Precautions

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.