Caution: Pregnant or nursing women or persons with known medical conditions should consult with their physician before using this or any natural health product. Keep out of the reach of children. There is enough iron in this product to seriously harm a child. If symptoms persist or worsen, consult a health care practitioner. Stop use and consult a health care practitioner if you develop skin lesions, unusual skin pigmentation, irritation of gastrointestinal tract, or changes in cardiac rhythm. Do not use if you have a cardiovascular disorder.
In the Heart Protection Study ( HPS ), involving 20,536 patients (age range 40-80 years, 25% women, 97% Caucasians, 3% other races) treated with simvastatin 40 mg/day (n=10,269) or placebo (n=10,267) over a mean of 5 years, only serious adverse reactions and discontinuations due to any adverse reactions were recorded. Discontinuation rates due to adverse reactions were % in patients treated with simvastatin compared with % in patients treated with placebo. The incidence of myopathy / rhabdomyolysis was < % in patients treated with simvastatin.
Simvastatin 20-40 mg/day modestly potentiated the effect of coumarin anticoagulants: the prothrombin time , reported as International Normalized Ratio (INR), increased from a baseline of to and from to in a normal volunteer study and in a hypercholesterolemic patient study, respectively. With other statins, clinically evident bleeding and/or increased prothrombin time has been reported in a few patients taking coumarin anticoagulants concomitantly. In such patients, prothrombin time should be determined before starting VYTORIN and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs. Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of VYTORIN is changed or discontinued, the same procedure should be repeated. Simvastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants.