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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 160 mg Tablets are 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. −…
Verbatim from this product's MHRA label. Tap a section to expand.
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.
Elderly patients (≥ 65 years old):
No dose adjustment is necessary. 73 m2 (see Patients with renal impairment). 73 m2, is present. 73 m2, the dose of Fenofibrate should not exceed 100mg standard or 67 mg micronized once daily. 73 m2, Fenofibrate should be discontinued.
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.
Hepatic disease:
Patients with hepatic disease have not been studied. Dietary measures initiated before therapy should be continued. g. 3 months) serum lipid levels have not been reduced satisfactorily, complementary or different therapeutic measures should be considered.
Method of administration:
Tablets should be swallowed whole during a meal.
The frequencies of adverse events are ranked according top the following:
Very common ( > 1/10), Common (> 1/100, < 1/10), Uncommon (> 1/1,000, < 1/100), Rare (>1/10,000, < 1/1,000), very rare ( < 1/10,000 including isolated reports Gastrointestinal: Common: Digestive, gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea, and flatulence) moderate in severity Uncommon: Pancreatitis * Hepato-biliary disorders: Common: Moderately elevated levels of serum transaminases (see Special Precautions for use).
Uncommon:
Development of gallstones Very rare: Episodes of hepatitis. g. jaundice, pruritus) indicative of hepatitis occur, laboratory tests are to be conducted for verification and fenofibrate discontinued, if applicable (see Special Warnings).
Cardiovascular system:
Uncommon: Thromboembolism (pulmonary embolism, deep vein thrombosis*) Skin and subcutaneous tissue disorder: Uncommon: rashes, pruritus, urticaria or photosensitivity reactions. g. sunlamp) in individual cases (even after many months of uncomplicated use) Musculoskeletal, connective tissue and bone disorders: Rare: diffuse myalgia, myositis, muscular cramps and weakness Not known: rhabdomyolysis Blood and lymphatic system disorders: Rare: decrease in haemoglobin and leukocytes Nervous system disorder: Rare: sexual asthenia Respiratory, thoracic and mediastinal disorders.
Not known: interstitial pneumopathies Investigation Uncommon: increases in serum creatinine and urea * In the FIELD study, a randomised placebo controlled trial performed in 9795 patients with type II diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate verses patients receiving placebo.
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 be monitored every 3 months during the first 12 months of treatment.
Attention should be paid to patients who develop increase in transaminase levels and therapy should be discontinued if ASAT and ALAT levels increase to more than 3 times the upper limit of the normal range or 100 IU. 8) This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridemia, a direct drug effect, or a secondary phenomenon mediated through bilary 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.
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 normal range). In such cases treatment with fenofibrate should be stopped.
Patients with pre-disposing factors for myopathy and/or rhabdomyolysis, including age above 70 years old, 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. The risk of muscle toxicity may be increased if the drug is administered with another fibrate or an HMG-CoA reductase inhibitor, especially in cases of pre- existing muscular disease.
73 m2), − children, − hypersensitivity to fenofibrate or any component of this medication, − known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen, − gall bladder disease. 6.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fenofibrate in United Kingdom.
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031. 074) 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
Consequently, the co-prescription of fenofibrate with a statin should be reserved to patients with severe combined dyslipidaemia and high cardiovascular risk without any history of muscular disease. This combination therapy should be used with caution and patients should be monitored closely for signs of 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 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.
Other warnings For hyperlipidaemic patients taking oestrogens or contraceptives containing oestrogens it should be ascertained whether the hyperlipidaemia is of primary or secondary nature (possible elevation of lipid values caused by oral oestrogen).
As fenofibrate 160 mg tablets contains lactose, patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. This medicine contains less than 1mmol sodium (23mg) per tablet, that is to say essentially ‘sodium-free’.