FENOFIBRATE

Posology Adults In adults, the recommended initial dose is three 67 mg capsules taken daily in divided doses. Fenofibrate should always be taken with food, because it is less well absorbed from an empty stomach. Dietary measures instituted before therapy should be continued.

The response to therapy should be monitored by determination of serum lipid values. The dosage may be altered within the range of two to four 67 mg capsules daily. Rapid reduction of serum lipid levels usually follows fenofibrate treatment, but treatment should be discontinued if an adequate response has not been achieved within three months.

4). Elderly patients (≥ 65 years old) No dose adjustment is necessary. 73 m2 (see Patients with renal impairment). Patients with renal impairment In renal dysfunction, the dosage may need to be reduced depending on the rate of creatinine clearance.

73 m2, is present. 73 m2, the dose of fenofibrate should not exceed 100 mg standard or 67 mg micronized once daily. 73 m2, fenofibrate should be discontinued. Patients with hepatic disease Patients with hepatic disease have not been studied.

Method of administration For oral administration

Estimated frequencies of events are ranked according to the following convention: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (≤1/10,000), not known (cannot be estimated from the available data).

The most commonly reported ADRs during Fenofibrate therapy are digestive, gastric or intestinal disorders. The following undesirable effects have been observed during placebo-controlled clinical trials (n=2344) with the below indicated frequencies: MedDRA system organ class Common >1/100, <1/10 Uncommon >1/1,000, <1/100 Rare >1/10,000, <1/1,000 Very rare <1/10,000 incl.

g. g. 031). 074). 5 μmol/L, and was reversible on discontinuation of fenofibrate treatment. The increased risk of venous thrombotic events may be related to the increased homocysteine level. The clinical significance of this is not clear.

In addition to those events reported during clinical trials, the following side effects have been reported spontaneously during postmarketing use of Fenofibrate. A precise frequency cannot be estimated from the available data and is therefore classified as “not known”.

- Respiratory, thoracic and mediastinal disorders: Interstitial lung disease. - Musculoskeletal, connective tissue and bone disorders: Rhabdomyolysis. g. g erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) - General disorders and administration site conditions: Fatigue Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Secondary causes of hyperlipidemia:

Secondary causes of hyperlipidemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease, pharmacological treatment, alcoholism, should be adequately treated before fenofibrate therapy is considered.

Secondary cause of hypercholesterolemia related to pharmacological treatment can be seen with diuretics, β-blocking agents, estrogens, progestogens, combined oral contraceptives, immunosuppressive agents and protease inhibitors. In these cases it should be ascertained whether the hyperlipidaemia is of primary or secondary nature (possible elevation of lipid values caused by these therapeutic agents).

Liver function:

As with other lipid lowering agents, increases have been reported in transaminase levels in some patients. In the majority of cases these elevations were transient, minor and asymptomatic. It is recommended that transaminase levels are monitored every 3 months during the first 12 months of treatment and thereafter periodically.

Attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if AST (SGOT) and ALT (SGPT) levels increase to more than 3 times the upper limit of the normal range. g. jaundice, pruritus), and diagnosis is confirmed by laboratory testing, fenofibrate therapy should be discontinued.

8). This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridaemia, a direct effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation, resulting in the obstruction of the common bile duct.

Muscle:

Muscle toxicity, including very rare cases of rhabdomyolysis, has been reported with administration of fibrates and other lipid-lowering agents. The incidence of this disorder increases in cases of hypoalbuminaemia and previous renal insufficiency.

73 m2) − Known gallbladder disease − Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen − Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridaemia