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FENOFIBRATE is a brand name for Fenofibrate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Fenofibrate - is indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following: - Treatment of severe hypertriglyceridaemia with or without low HDL cholesterol. - Mixed hyperlipidaemia when a statin is contraindicated or not tolerated. - Mixed…
Verbatim from this product's MHRA label. Tap a section to expand.
Dietary measures initiated before therapy should be continued. Response to therapy should be monitored by determination of serum lipid values. If an adequate response has not been achieved after several months, complementary or different therapeutic measures should be considered.
Posology:
Adults: The recommended dose is one tablet containing 160 mg fenofibrate taken once daily. Patients currently taking one Fenofibrate 200mg capsule can be changed to one Fenofibrate 160 mg tablet without further dose adjustment. Special populations Elderly patients (≥ 65 years old) No dose adjustment is necessary.
73 (see Patients with renal impairment). 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.
Hepatic impairment:
Fenofibrate is not recommended for use in patients with hepatic impairment due to the lack of data.
Paediatric population:
The safety and efficacy of fenofibrate in children and adolescents younger than 18 years has not been established. No data are available. Therefore the use of fenofibrate is not recommended in paediatric subjects under 18 years.
Method of administration:
Tablet should be swallowed whole during a meal.
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) and post- marketinga 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. 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.
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 cause of hypercholesterolemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver disease or 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.
Pancreas:
Pancreatitis has been reported in patients taking fenofibrate (see sections Contraindications and Undesirable effects). This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridemia, a direct drug effect, or a secondary phenomenon mediated through biliary tract stone or sludge formation with obstruction of the common bile duct.
1. In addition, Fenofibrate should not be taken in patients allergic to peanut or arachis oil or soya lecithin or related products due to the risk of hypersensitivity reactions.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Muscle:
Muscle toxicity, including rare cases of rhabdomyolysis, with or without renal failure, has been reported with administration of fibrates and other lipid- lowering agents. The incidence of this disorder increases in case of hypoalbuminaemia and previous renal insufficiency.
Patients with pre- disposing factors for myopathy and/or rhabdomyolysis, including age above 70 years, personal or familial history of hereditary muscular disorders, renal impairment, hypothyroidism and high alcohol intake, may be at an increased risk of developing rhabdomyolysis.
For these patients, the putative benefits and risks of fenofibrate therapy should be carefully weighed up. Muscle toxicity should be suspected in patients presenting diffuse myalgia, myositis, muscular cramps and weakness and/or marked increases in CPK (levels exceeding 5 times the upper normal range).
In such cases treatment with fenofibrate should be stopped. The risk of muscle toxicity may be increased if the drug is administered with another fibrate or an HMG-CoA reductase inhibitor, especially in case of pre- existing muscular disease.
Consequently, the co-prescription of fenofibrate with HMG-CoA reductase inhibitor or another fibrate should be reserved to patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscular disease and with a close monitoring of potential muscle toxicity.
3). Fenofibrate should be used with caution in patients with mild to moderate renal insufficiency. 2). Reversible elevations in serum creatinine have been reported in patients receiving fenofibrate monotherapy or co-administered with statins.
Elevations in serum creatinine were generally stable over time with no evidence for continued increases in serum creatinine with long term therapy and tended to return to baseline following discontinuation of treatment. 4% with statin monotherapy.
3% of patients receiving co- administration had clinically relevant increases in creatinine to values > 200 μmol/L. Treatment should be interrupted when creatinine level is 50% above the upper limit of normal. It is recommended that creatinine is measured during the first 3 months after initiation of treatment and periodically thereafter.
Excipients:
Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Sodium benzoate This medicine contains 10 micrograms of sodium benzoate (E211) per tablet.
Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.