Expiration date: 10/2025

The composition and form of issue:

Tablets, film-coated. 1 tablet contains:

the fenofibrate (micronized) 145 mg

excipients: sucrose — 145 mg of sodium lauryl — 10.2 mg lactose monohydrate — 132 mg crospovidon — 75,5 mg MKC — 84,28 mg silica colloidal anhydrous — hypromellose of 1.72 mg — 29 mg docusate sodium and 2.9 mg magnesium stearate 0.9 mg 

shell (Opadry OY-B-28920): 25.1 mg (vinyl alcohol to 11.43 mg of titanium dioxide of 8.03 mg talc — 5,02 mg soy lecithin — 0.5 mg xanthan gum and 0.12 mg) 

blistere in 10 PCs. in cardboard pack 1, 2, 3, 5, 9 and 10 blisters or blistere in 14 PCs. in cardboard pack 2, 6 and 7 blisters or blistere in 10 PCs in a carton carton 28 and 30 blisters (for hospitals).

Tablets, film-coated. 1 tablet contains:

the fenofibrate 160 mg

auxiliary substances: sodium lauryl sulfate and 5.6 mg lactose monohydrate — 138,4 mg povidone — 160 mg crospovidon — 96 mg MKC — 115 mg silicon dioxide colloidal — 12,6 mg of sodium fumarate and 6.4 mg 

shell (Opadry OY-B-28920): 28 mg (vinyl alcohol to 12.75 mg of titanium dioxide of 8.96 mg of talc and 5.6 mg soy lecithin — 0.56 mg gum xanthan — 0.13 mg)

blistere in 10 PCs. in cardboard pack 1, 2, 3, 5, 9 and 10 blisters or blistere in 14 PCs. in cardboard pack 2, 6 and 7 blisters.

Description pharmaceutical form:

Tablets (145 mg): oblong tablets, film-coated white color, with the inscription "145" on one side and logo = — on the other.

Tablets (160 mg): oblong tablets, film-coated white color, with the inscription "160" on one side and logo = — on the other.

Pharmacokinetics:

Tricor 145 mg tablets, film-coated contain 145 mg of micronized phenofibrate in the form of nanoparticles.

Source fenofibrate in plasma is not detected. The major plasma metabolite is fenofibric acid.

Cmax in plasma achieved through 2-4 h after ingestion. With prolonged use, the concentration of drug in plasma remains stable, regardless of the individual patient.

In contrast to the previous dosage forms of phenofibrate, the maximum concentration in the blood plasma and the total effect of phenofibrate in the form of nanoparticles is not dependent on food intake. Therefore, Tricor 145 mg may be taken at any time regardless of the meal.

Fenofibrate acid binds strongly to plasma albumin (more than 99%).

T1/2 fenofibric acid for about 20 h.

After oral administration of the fenofibrate is rapidly hydrolyzed by serum esterases. In the plasma is detected only the primary active metabolite of phenofibrate — Fenofibrate acid. The fenofibrate is not a substrate for CYP3A4. Not involved in the microsomal metabolism.

Write mainly with urine in the form of fenofibric acid and glucuronide conjugate. Within 6 days fenofibrate is excreted almost completely. Total clearance fenofibrate acid determined in elderly patients does not change.

The drug is not cumulates after a single dose and with prolonged use.

When hemodialysis is not displayed.

Tricor 160 mg tablets, film-coated, has a higher bioavailability compared with the earlier dosage forms phenofibrate.

Source fenofibrate in plasma is not detected. The major plasma metabolite is fenofibric acid.

Cmax in plasma is reached after 4-5 h after ingestion. With prolonged use, the concentration of drug in plasma remains stable. Suction phenofibrate increases while taking food.

Fenofibrate acid binds strongly to plasma albumin (more than 99%).

T1/2 fenofibric acid for about 20 h.

In the plasma is detected only the major metabolite of phenofibrate — Fenofibrate acid. Write mainly with urine in the form of fenofibric acid and glucuronide conjugate. Within 6 days fenofibrate is excreted almost completely. Total clearance fenofibric acid determined in elderly patients does not change.

The drug is not cumulates after a single dose and with prolonged use.

When hemodialysis is not displayed.

Description pharmacological action:

The fenofibrate is a derivative fibroevoy acid, the ability to change the lipid content in the human body, mediated by activation of PPAR&alpha. Activating receptors PPAR&alpha (alpha-receptors, peroxisome proliferator-activated), fenofibrate increases lipolysis and elimination of atherogenic plasma lipoprotein with a high content of triglycerides by activating lipoprotein lipase and reducing synthesis of apolipoprotein CIII. Activation of PPAR&alpha also leads to increased synthesis of apolipoproteins AI and AII.

The above-described phenofibrate effects on lipoproteins lead to a reduction in the content of fractions of LDL and VLDL, which include an apolipoprotein b, and increase the content of HDL fraction, which include apolipoproteins AI and AII.

In addition, due to the correction of infringements of synthesis and catabolism of VLDL, fenofibrate increases LDL clearance and reduces small and dense particle size LDL, increase which is observed in patients with atherogenic phenotype of lipids (frequent violation in patients with CHD risk).

In clinical studies, it was observed that the use of phenofibrate lowers total cholesterol by 20-25% and triglycerides by 40-55% when raising HDL-cholesterol by 10-30%. In patients with hypercholesterolemia who have LDL-cholesterol is reduced by 20-35%, the use of phenofibrate resulted in a reduction ratios: "total cholesterol/HDL-cholesterol", "LDL-cholesterol/HDL-cholesterol and APO b/APO AI," which are markers of atherogenic risk.

Given the impact of phenofibrate in the LDL-cholesterol and triglycerides, use of the drug is effective in patients with hypercholesterolemia, as accompanied by and not accompanied by hypertriglyceridemia, including secondary giperlipoproteinemiey, such as diabetes type 2.

During treatment fenofibrate can be significantly reduced and even completely disappear extravascular deposits of cholesterol (tendinous and tuberous xanthomas).

In patients with elevated levels of fibrinogen treated fenofibratom, showed a significant decrease in this indicator, as well as in patients with elevated Lp(a). Other markers of inflammation such as C-reactive protein, also decreased in the treatment fenofibratom.

For patients with dyslipidemia and hyperuricemia additional advantage is phenofibrate uricosuric effect leading to a decrease in the concentration of uric acid by approximately 25%.

During clinical studies and in animal experiments it has been shown that fenofibrate reduces platelet aggregation caused by adenosine diphosphate, arachidonic acid and epinephrine.

Indications:

• hypercholesterolemia and isolated hypertriglyceridemia or in combined (dyslipidemia type IIa, IIb, III, IV, V) (tablet 145 mg) and(dyslipidemia type IIa, IIb, III*, IV, V*) (tablet 160 mg) in patients for whom diet or other non-drug therapeutic measures (e.g. weight reduction or increased physical activity) proved to be ineffective, especially when there is associated with dyslipidemia risk factors such as hypertension and Smoking
  
• secondary hyperlipoproteinemia in cases where hyperlipoproteinemia persists despite effective treatment of the underlying disease (e.g. dyslipidemia in diabetes mellitus).
  
• In applying the drug Tricor patients should follow the diet that they followed before treatment.
  

* In clinical studies involved only few patients with dyslipidemia III and V type.

Contraindications:

• hypersensitivity to fenofibrate or other components of LS
  
• severe liver failure (including cirrhosis)
  
• severe renal insufficiency (Cl creatinine <20ml/min)
  
• the age of 18
  
• a history of photosensitivity or phototoxicity during treatment with fibrates or Ketoprofen
  
• diseases of the gallbladder
  
• breastfeeding
  
• congenital galactosemia, lactase deficiency, malabsorption of glucose and galactose (product contains lactose)
  
• phenylketonuria congenital, sucrase-isomaltase (it contains sucrose) (tablet 145 mg)
  
• an allergic reaction to peanuts, peanut oil, soy lecithin or related products in the medical history (in connection with risk of development of hypersensitivity reactions).
  

With caution:

• hepatic and/or renal failure
  
• hypothyroidism
  
• patients who abuse alcohol
  
• elderly patients
  
• patients with burdened anamnesis for hereditary muscle diseases
  
• concomitant use of oral anticoagulants, inhibitors of HMG-COA reductase inhibitors (see "Interactions").
  

Application of pregnancy and breast-feeding:

There are few data on the use of phenofibrate pregnant women. In experiments on animals teratogenic effect phenofibrate was not observed. Embryotoxicity was observed when administered in the course of preclinical doses toxic to the maternal organism. The potential risk for humans is unknown. Therefore, during pregnancy tablets Tricor can only be used after careful evaluation of the balance of risks and benefits.

In the absence of data on the safety of the drug is contraindicated in breastfeeding.

Side effects:

Frequency of adverse reactions listed below is defined as follows: very common (&GE. 1/10), often (>1/100, <1/10), sometimes (>1/1000, <1/100) rare (>1/10000, <1/1000) very rare (<1/10000), including individual messages.

By the blood: often — pain in the abdomen, nausea, vomiting, diarrhea, and flatulence of moderate severity sometimes cases of pancreatitis.

The liver: often — moderate increase in the concentration of serum transaminases and sometimes the formation of gall stones is very rare episodes of hepatitis. If you have symptoms of hepatitis (jaundice, pruritus) should conduct laboratory studies and, if confirmed hepatitis, to cancel the fenofibrate. (See. "Special instructions").

On the part of the musculoskeletal system and connective tissue: rare: diffuse myalgia, myositis, muscular cramps and weakness very rare — rhabdomyolysis (acute necrosis of skeletal muscles).

Vascular disorders: sometimes, venous thromboembolism (pulmonary embolism, deep vein thrombosis).

From the blood and lymphatic system: rarely — increased in hemoglobin and white blood cells.

From the nervous system: rarely — sexual dysfunction, headache.

From the side of respiratory system: very rarely — interstitial pneumopathy.

The skin and subcutaneous fat: sometimes — rash, itching, urticaria or photosensitivity reactions rare — alopecia very rare — photosensitivity, accompanied by erythema, formation of bullae, or nodules on the skin areas exposed to sunlight or artificial UV radiation, for example, quartz lamps (in some cases, after months of use without any complications).

Laboratory tests: sometimes — increased creatinine and urea in serum.

Drug interactions:

Oral anticoagulants: fenofibrate enhances the effect of oral anticoagulants and can increase bleeding risk due to displacement of anticoagulant from bonding with blood plasma proteins.

At the beginning of treatment fenofibratom recommended to reduce the dose of anticoagulants approximately one-third followed by a gradual dose-finding. Selection of dose is recommended under the control of the level of INR.

Cyclosporine: describes some severe cases of reversible renal decline during simultaneous treatment fenofibrate and cyclosporine. It is therefore necessary to monitor the status of renal function in these patients and to cancel the fenofibrate in the event of serious changes in laboratory parameters.

Inhibitors of HMG-COA reductase inhibitors and other fibrates: when receiving phenofibrate simultaneously with inhibitors of HMG-COA reductase inhibitors or other fibrates increases the risk of serious toxic effect on muscle fibers (see "Special instructions").

Enzymes of cytochrome P450: studies of microsomes from human liver in vitro have shown that the fenofibrate and fenofibric acid are not inhibitors of the following cytochrome P450 isoenzymes: CYP3A4, CYP2D6, CYP2E1, or CYP1A2. In therapeutic concentrations, these compounds are weak inhibitors of the isoenzymes CYP2C19 and CYP2A6 and weak or moderate inhibitors of CYP2C9.

Method of application and dose:

Inside, swallowing whole without chewing, with a glass of water, at any time of the day regardless of food intake (tab. 145 mg) and simultaneously with food intake (tablet 160 mg).

Adults 1 tablet 1 time per day. Patients taking 1 capsule. Have lipantil 200 M or 1 tablet Tricor of 160 mg/day, can go to reception 1 tab. Tricor 145 mg no adjustment dose. Patients taking 1 capsule. Have lipantil 200 M per day, you can go to the reception 1 tab. Tricor 160 mg no adjustment dose.

Elderly patients: the recommended standard dose for adults (for 1 tablet Tricor 1 time per day).

Patients with renal insufficiency requires a reduced dose (see "Special instructions").

The use of the drug in patients with liver disease have not been studied.

The drug should be taken for a long period of time, while continuing to follow a diet, which the patient adhered to before treatment Triceram. The effectiveness of drug treatment should be periodically evaluated by a physician.

The effectiveness of therapy should be assessed on the content of lipids (total cholesterol, LDL cholesterol, triglycerides) in the blood serum. In the absence of therapeutic effect after several months of therapy (usually after 3 months) should consider the appropriateness of the appointment of concomitant or alternative therapies.

Overdose:

Cases of overdose not described. The specific antidote is unknown. If you suspect an overdose should be symptomatic and to appoint, if necessary, supportive treatment.

Hemodialysis is ineffective.

Special instructions:

Before you start treatment with Trikora, there should be an appropriate treatment to resolve the causes of secondary hypercholesterolemia, for example, under such conditions and diseases as uncontrolled diabetes mellitus type 2, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, the effects of drug therapy, alcoholism.

The effectiveness of therapy should be assessed on the content of lipids (total cholesterol, LDL cholesterol, triglycerides) in the blood serum. In the absence of therapeutic effect after several months of therapy (usually after 3 months) should consider the appropriateness of the appointment of concomitant or alternative therapies.

Patients with hyperlipidemia receiving estrogens or hormonal contraceptives containing estrogen, it is necessary to determine whether the hyperlipidemia primary or secondary nature. In such cases, the increase in lipid levels can be caused by taking estrogen.

Liver function: when receiving Tricor and other drugs that reduce the concentration of lipids, some patients have described increase in liver transaminases. In most cases, this increase was transient, minor and asymptomatic. During the first 12 months of treatment is recommended to monitor transaminase levels (ALT, AST) every 3 months. Patients in whom the treatment increased concentrations of transaminases, require attention, and in the case of increasing the concentration of ALT and AST more than 3 times compared with the upper limit of normal, stop taking the drug.

Pancreatitis: there were described cases the development of pancreatitis during treatment with Tracorum. Possible causes of pancreatitis in these cases were: lack of efficacy of the drug in patients with severe hypertriglyceridemia, a direct drug effect, as well as the secondary phenomena associated with the presence of stones or sludge in the gall bladder, accompanied by obstruction of the common bile duct.

Muscles: when receiving Tricor and other drugs that reduce the concentration of lipids, described cases of toxic effects on muscle tissue, including very rare cases of rhabdomyolysis. The frequency of such violations increased in the case of hypoalbuminemia and renal failure in history. The possibility of this complication increases in cases of hypoalbuminemia and renal failure.

Toxic effect on muscle tissue can be suspected based on the patient's complaints of weakness, diffuse myalgia, myositis, muscular spasms and cramps and/or marked increase in activity of creatine kinase (more than 5 times in comparison with the upper limit of normal). In these cases, the treatment Triceram need to stop.

The risk of rhabdomyolysis may be increased in patients with a predisposition to myopathy and/or rhabdomyolysis, including age above 70 years, family history of hereditary muscle diseases, impaired renal function, hypothyroidism, alcohol abuse. Such patients should be prescribed only if the expected benefit outweighs the potential risk of rhabdomyolysis.

When taking Tricor simultaneously with inhibitors of HMG-COA reductase inhibitors or other fibrates increases the risk of serious toxic effect on muscle fibers, especially if the patient before treatment was suffering from muscle disease. In this regard, the joint appointment of Tricor and a statin is only valid when the patient has a severe mixed dyslipidemia and high cardiovascular risk, in the absence of muscle disease in anamnesis and in the conditions of close monitoring, aimed at identifying signs of development of toxic effect on muscle tissue.

Renal function: in the case of increasing the concentration of creatinine more than 50% above the upper limit of normal, treatment should be suspended. In the first 3 months of treatment to determine the concentration of creatinine.

In applying the drug had no effect on the ability to drive a car or operate machinery.