Patients with liver disease. Use of the drug in patients with liver disease has not been studied.
The drug should be taken for a long time, while continuing to follow a diet that is adhered to the patient prior to treatment aromasin.
From the gastrointestinal tract:
> 1/100, <1/10: abdominal pain, nausea, vomiting, diarrhea and flatulence moderate in severity.
> 1/1000, <1/100: cases of pancreatitis.
> 1/100, <1/10: a moderate increase in the concentration of serum transaminases.
> 1/1000, <1/100: the formation of gallstones.
<1/10000: hepatitis. If you have symptoms of hepatitis (jaundice, itchy skin) should be carried out laboratory tests and, if confirmed hepatitis cancel fenofibrate. (See. “Special Instructions” section).
On the part of the musculoskeletal system and connective tissue:
> 1/10000, <1/1000: diffuse myalgia, myositis, muscle spasm and weakness.
<1/10000: rhabdomyolysis, increased creatinine phosphokinase .
> 1/1000, <1/100: venous thromboembolism (pulmonary embolism, deep vein thrombosis).
From the circulatory and lymphatic system:
> 1/10000, <1/1000: increased concentration of hemoglobin and white blood cells.
From the nervous system:
> 1/10000, <1/1000: sexual dysfunction, headache.
From the respiratory system:
<1/10000: interstitial pneumopathy aromasin.
Skin and subcutaneous tissue:
> 1/1000, <1/100: rash, pruritus, urticaria or photosensitivity reactions.
> 1/10000, <1/1000: alopecia.
<1/10000: photosensitivity, accompanied by erythema , blistering or nodules on the skin areas exposed to sunlight or artificial UV light (e.g., quartz tubes), in some cases (even after many months of use without any complications).
Laboratory tests: > 1/1000, <1/100: increased creatinine and urea in serum.
Cases of overdose have not been described. A specific antidote is not known. If you suspect an overdose, symptomatic and should be appointed, if necessary, supportive care. Hemodialysis is ineffective.
Interaction with other drugs
Fenofibrate enhances oral anticoagulant effect and may increase the risk of bleeding, which is associated with the displacement of the anticoagulant binding sites to plasma proteins.
At the beginning of the treatment with fenofibrate it is recommended to reduce the dose of anticoagulants by about a third, followed by gradual aromasin dose selection. Selection of doses recommended controlled MHO level (international normalized ratio).
described several severe cases of reversible decrease in renal function during simultaneous treatment with fenofibrate and cyclosporin. It is therefore necessary to monitor the status of renal function in these patients, and to cancel the fenofibrate in the event of a serious change in laboratory parameters.
HMG-CoA reductase inhibitors and other fibrates
When receiving fenofibrate together with inhibitors reductase inhibitors or other fibrates increases the risk of serious toxic effects on muscle fibers ).
Cytochrome P450 Enzymes: microsomes in vitro studies of human liver have shown that fenofibrate and fenofibric acid are not inhibitors of the following cytochrome isoenzymes (. At therapeutic concentrations of these compounds are weak inhibitors isozyme, and weak or moderate inhibitors .
should conduct appropriate treatment to eliminate the cause of secondary hypercholesterolemia, for example, in diseases such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, Dysproteinemia, obstructive liver disease, the effects of drug therapy Before treatment aromasin, alcoholism.
Efficacy of therapy should be evaluated on lipid content (total cholesterol, aromasincholesterol, triglyceride) in the blood serum. In the absence of a therapeutic effect after a few months of therapy (usually after 3 months -x) to consider whether the use of alternative or concomitant therapy. Patients with hyperlipidemia, taking estrogen or hormonal contraceptives containing estrogens, it is necessary to find out whether hyperlipidemia primary or secondary nature. In such cases, increase of lipid levels may be caused by intake of estrogens
Liver function: When you receive , and other drugs that reduce the concentration of lipids in some patients described increase in “liver” transaminases. In most cases, this increase was temporary, minor and asymptomatic. During the first 12 months of treatment, it is recommended to control the level of transaminasesevery. Patients on treatment with increased transaminase concentrations, require attention, and in the case of increasing the concentration of s more than 3 times compared to the upper limit of normal stop taking the drug.