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ETC / RX - Anti-diabetics - Fenofib 200, 300

COMPOSITION:

Fenofibrate: 200 mg, 300 mg


INDICATIONS:

FENOFIB is used to reduce low-density lipoprotein (LDL)-cholesterol, total triglycerides, and apolipoprotein B, and to increase high-density lipoprotein (HDL)-cholesterol, in the management of hyperlipidaemias, including type IIa, type IIb, type III, type IV, and type V, in combination with the diet.


ADMINISTRATION AND DOSAGE:

FENOFIB is administered in combination with the diet, by mouth. Should be taken with food.

Adults: 100 mg capsule: Three capsules per day, or 160 mg or 200 mg or 300 mg capsule: One capsule per day. The dose should be chosen according to response of individual.

Children over 10 years of age: The maximum dose is 5 mg/kg per day, equivalent to one 100 mg capsule daily per 20 kg body weight.

Elderly: In elderly patients without renal impairment, the normal adult dose is recommended.

Patients with mild to moderate renal impairment: The dosage should be reduced depending on the rate of creatinine clearance:

  • Creatinine clearance 20 to 60 mL/min: Two 100 mg capsules daily.
  • Creatinine clearance less than 20 mL/min: One 100 mg capsule daily.

CONTRAINDICATIONS:

  • Hypersensitivity to fenofibrate or any component of this medication.
  • Severe hepatic failure (including biliary cirrhosis), severe renal failure.
  • Known photo-allergy reaction during treatment with fibrates or ketoprofen.
  • Gallbladder disease.
  • Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.
  • Pregnancy and lactation.
  • Children under 10 years.

WARNINGS AND PRECAUTIONS:

  • Check hepatic and renal function before starting initial therapy.
  • Test serum transaminase every 3 months, during the first 12 months of treatment. Treatment should be interrupted in the event of ALAT (SGPT) or ASAT (SGOT) elevations to more than 3 times the upper limit of the normal range or more than one hundred international units.
  • Pancreatitis has been reported in patients taking fenofibrate. This occurrence may represent a failure of efficacy in patients with severe hypertriglyceridaemia, or a secondary phenomenon mediated through biliary tract stone or sludge formation, resulting in the obstruction of the common bile duct.
  • 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 of CPK. 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 cases of pre-existing muscular disease. 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. The patients should be monitored closely for signs of muscle toxicity.

Pregnancy and lactation: There are no adequate data from the use of fenofibrate in pregnant women. Animal studies have not demonstrated any teratogenic effects. The potential risk for humans is unknown.
There are no data on the excretion of fenofibrate and/or its metabolites into breast milk. It is therefore recommended that FENOFIB should not be administered to women who are pregnant or breast feeding.
Effects on ability to drive and use machines: None reported.


SIDE EFFECTS:

Fenofibrate is generally well tolerated. Adverse reactions are generally minor, transient and do not interfere with treatment.
Common: Digestive, gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea, and flatulence).
Uncommon: Pancreatitis, thromboembolism, rashes, pruritus, urticaria or photosensitivity reactions; in individual cases (even after many months of uncomplicated use) cutaneous photosensitivity may occur with erythema, vesiculation or nodulation, headache, fatigue, vertigo.
Rare: Increases in serum transaminases, increases in serum creatinine and urea, slight decrease in haemoglobin and leukocytes, myalgia, myositis, muscular cramps and weakness.
Very rare: Interstitial pneumopathies, rhabdomyolysis.


INTERACTIONS:

  • Fenofibrate and other fibrates may enhance the effects of oral anticoagulants; therefore, the dose of anticoagulant should be reduced by about one-third when treatment with a fibrate is started, and then adjusted gradually if necessary.
  • The risk of serious muscle toxicity and acute pancreatitis is increased if fenofibrate is used concomitantly with HMG-CoA reductase inhibitors (e.g. pravastatin, simvastatin, fluvastatin) or other fibrates.
  • Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and cyclosporin. The renal function of these patients must therefore be closely monitored and the treatment with fenofibrate stopped in the case of severe alteration of laboratory parameters.

PRESENTATION:

Box of 4 blisters x 7 capsules.
Box of 7 blisters x 4 capsules.
Box of 5 blisters x 4 capsules.
Box of 5 blisters x 6 capsules.