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Bezafibrate oral modified release

Updated 2 Feb 2023 | Fibrates


Oral modified release formulations of bezafibrate.

Drugs List

  • bezafibrate 400mg modified release tablet
  • BEZALIP MONO 400mg modified release tablet
  • LIPOZATE 400mg modified release tablet
  • Therapeutic Indications


    Mixed hyperlipidaemia when statin is contraindicated or not tolerated
    Severe hypertriglyceridaemia with or without low HDL cholesterol



    The recommended dosage is 400mg bezafibrate once daily either in the morning or at night.

    Patients with Renal Impairment

    The modified release tablet is contraindicated in patients with renal impairment (creatinine clearance less than 60 ml/minute or serum creatinine greater than 135 micromol/L). Such patients should be treated with standard release bezafibrate 200mg tablets using an appropriately reduced daily dosage.

    Special care is needed in patients with renal impairment, as progressive increases in serum creatinine concentration or failure to follow dosage guidelines may result in myotoxicity (rhabdomyolysis). Discontinue bezafibrate immediately and monitor renal function closely if myotoxicity is suspected or creatine kinase concentration increases significantly.


    Children under 18 years
    Creatine kinase levels over 5 times upper limit of normal
    Photoallergic or phototoxic reactions to fibrates
    Gallbladder disease
    Nephrotic syndrome
    Renal dialysis
    Renal impairment - creatinine clearance below 60ml/minute
    Severe hepatic impairment

    Precautions and Warnings

    Family history of hereditary muscular disorders
    Major surgery
    Patients over 65 years
    Predisposition to myopathy or rhabdomyolysis
    Severe infection
    Diabetes mellitus
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    Hereditary muscular disorder
    History of muscular toxicity secondary to fibrates
    History of muscular toxicity secondary to HMG-CoA reductase inhibitors
    Lactose intolerance

    Advise ability to drive/operate machinery may be affected by side effects
    Correct hypothyroidism before treatment
    Exclude/correct secondary causes of dyslipidaemia prior to treatment
    May contain polysorbate
    Some formulations contain lactose
    If cholelithic symptoms occur perform appropriate diagnostic procedures
    Monitor antidiabetic drug treatment
    Monitor creatine kinase levels in patients at risk of rhabdomyolysis
    Monitor diabetic patients during initiation of therapy
    Advise patients to report muscle pain/tenderness/weakness
    Discontinue if myopathy is suspected
    Discontinue if an adequate response not achieved within 3 months
    Discontinue if creatine kinase concentration increases significantly
    Discontinue immediately if rhabdomyolysis occurs
    Dietary restrictions should be maintained
    Female: Ensure adequate contraception during treatment

    Bezafibrate should be used alongside diet and other measures such as weight loss, physical activity and adequate treatment of other metabolic disorders such as diabetes and gout.

    Secondary causes of dyslipidaemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemia, obstructive liver disease, pharmacological treatment and alcoholism should be adequately treated before therapy starts.

    Bezafibrate is known to alter the composition of bile and isolated reports of gallstones have been reported.

    Oestrogens may lead to a rise in lipid levels. The use of bezafibrate in patients taking oestrogens or oestrogen-containing preparations must considered on an individual basis.

    Bezafibrate is contraindicated in patients with severe hepatic disease (other than fatty infiltration of the liver associated with raised triglyceride values).

    Patients susceptible to the gastrointestinal effects of bezafibrate should initiate treatment by slowly increasing the dose over 5 to 7 days (see other formulations).

    The response to therapy is normally rapid, however a progressive improvement may be apparent over a number of weeks. Treatment should be withdrawn if a sufficient therapeutic response has not been achieved within 3 to 4 months.

    If bezafibrate is given in combination with anion-exchange resins, they must be taken a minimum of 2 hours apart.

    Pregnancy and Lactation


    Bezafibrate is contraindicated during pregnancy.

    Use of bezafibrate during pregnancy is contraindicated by the manufacturer. At the time of writing there is limited published information regarding the use of bezafibrate during pregnancy. Potential risks are unknown.


    Bezafibrate is contraindicated during breastfeeding.

    The manufacturer advises that the patient either discontinues bezafibrate or discontinues breastfeeding. At the time of writing there is insufficient information on the excretion of bezafibrate or its metabolites in human milk. A risk to the infant cannot be excluded.

    Side Effects

    Abdominal distension
    Abdominal pain
    Acute renal failure
    Anaphylactic reaction
    Creatine phosphokinase increased
    Decreased alkaline phosphatase
    Decreased appetite
    Erectile dysfunction
    Erythema multiforme
    Gamma glutamyl transferase (GGT) decreased
    Gamma glutamyl transferase (GGT) increased
    Gastro-intestinal disturbances
    Haemoglobin decrease
    Hypersensitivity reactions
    Increase in serum transaminases
    Increased platelet count
    Interstitial lung disease
    Muscle cramps
    Muscle weakness
    Peripheral neuropathy
    Serum creatinine increased
    Stevens-Johnson syndrome
    Thrombocytopenic purpura
    Toxic epidermal necrolysis
    White blood cell count decreased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: September 2016

    Reference Sources

    Summary of Product Characteristics: Bezalip Mono 400mg tablets. Actavis UK Limited. Revised October 2015.

    Summary of Product Characteristics: Fibrazate XL 400mg Modified Release Tablets. Sandoz Ltd. Revised October 2015.

    Summary of Product Characteristics: Lipozate 400mg prolonged-release tablets. Noumed Life Sciences Ltd. Revised January 2022.

    NICE Evidence Services Available at: Last accessed: 07 December 2022

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