Bezafibrate/Bezalip

Elevated triglyceride levels and mixed lipid abnormalities can increase cardiovascular risk, and some patients require a non-statin approach to lipid management. Bezafibrate tablets are a prescription-only fibrate medicine used in adults for the treatment of hyperlipidaemia, including raised triglycerides and mixed dyslipidaemia. Sold under the brand name Bezalip in the modified release 400 mg formulation, bezafibrate is particularly effective at triglyceride management and can be used alone or alongside dietary measures and other lipid-lowering medicines when clinically appropriate. A prescription can only be issued following a clinical consultation.

Bezafibrate is an oral prescription medicine belonging to the fibrate class of lipid-lowering medicines. The brand name Bezalip refers to the modified release 400 mg tablet formulation. Fibrates are a distinct class from statins and work through a different mechanism. Where statins primarily target LDL cholesterol reduction, fibrates have their strongest effect on triglyceride management and HDL cholesterol improvement, making them particularly useful when triglyceride levels are the primary concern or when LDL control alone is insufficient.

Bezafibrate is licensed in the UK for the treatment of hyperlipidaemia of types IIa, IIb, III, IV, and V where dietary measures and other appropriate treatments have been inadequate. This covers a range of lipid abnormalities including primary hypercholesterolaemia, combined hyperlipidaemia, hypertriglyceridaemia, and mixed dyslipidaemia. The modified release formulation delivers bezafibrate gradually over time, allowing a single once daily evening dose to provide effective lipid management throughout the following day.

Bezafibrate is available as a single strength in the Bezalip modified release formulation: 400 mg taken once daily. A standard release 200 mg bezafibrate tablet is also available from other manufacturers but requires three times daily dosing and is a different product.

Bezafibrate lowers lipid levels through its action as a peroxisome proliferator-activated receptor alpha (PPAR alpha) agonist.

PPAR Alpha Activation. Bezafibrate activates PPAR alpha receptors inside cells, particularly in the liver and muscle tissue. PPAR alpha is a nuclear receptor that regulates the expression of genes involved in fatty acid metabolism and lipoprotein production. When PPAR alpha is activated by bezafibrate, several metabolic effects occur that together improve the lipid profile.

Effects on Blood Lipids. Activation of PPAR alpha by bezafibrate increases the activity of lipoprotein lipase, the enzyme that breaks down triglyceride rich particles in the blood. This leads to a significant reduction in plasma triglyceride levels. At the same time, bezafibrate reduces the production of VLDL particles by the liver, which further lowers circulating triglycerides. Bezafibrate also raises HDL cholesterol by increasing the production of apolipoprotein A-I and A-II, the structural proteins of HDL particles.

The effect of bezafibrate on LDL cholesterol is less predictable and more modest than its effect on triglycerides and HDL. In patients with pure hypertriglyceridaemia, LDL may actually increase slightly as triglyceride rich particles are broken down. In patients with mixed dyslipidaemia, bezafibrate can produce a modest LDL reduction. Overall, bezafibrate is most effective as part of a broader lipid management strategy where triglyceride control and HDL improvement are treatment priorities.

Always take Bezalip exactly as your prescriber instructs. Read the Patient Information Leaflet supplied with your medicine before starting treatment.

• Take one Bezalip 400 mg modified release tablet once daily in the evening, with or just after the evening meal.
• Swallow the tablet whole with a glass of water. Do not crush, chew, or break the tablet, as this destroys the modified release mechanism and delivers the full dose too rapidly.

If you miss a dose, take it as soon as you remember on the same evening. If you only remember the following morning, skip the missed dose and take the next dose as normal in the evening. Do not take two doses on the same day. Do not stop taking Bezalip without speaking to your prescriber first, as lipid management requires ongoing treatment.

Your prescriber will arrange blood tests to check your lipid levels before and after starting treatment, and will monitor liver and kidney function periodically. Bezafibrate is substantially excreted by the kidneys, and kidney function is particularly important in assessing dose appropriateness.

Bezalip 400 mg modified release tablets are the only strength available through this service. One tablet is taken once daily in the evening with a meal. This once daily dosing schedule is a practical advantage of the modified release formulation over standard release bezafibrate, which requires three times daily dosing.

Dose reduction is required in patients with kidney impairment. The SmPC specifies reduced dosing for patients whose kidney function is below certain thresholds, and bezafibrate may need to be avoided entirely in patients with severe kidney impairment. Your prescriber will assess your kidney function before and during treatment and will determine whether the standard 400 mg once daily dose is appropriate for you. Do not change your dose without medical advice.

Like all medicines, bezafibrate can cause side effects.

Common Side Effects (may affect up to 1 in 10 people):

• Gastrointestinal effects including nausea, abdominal discomfort, bloating, and diarrhoea. These are often mild, and taking the tablet with food helps reduce discomfort.
• Muscle aches or weakness (myalgia). Contact your prescriber if you experience unexplained muscle pain, tenderness, or weakness.

Uncommon Side Effects (may affect up to 1 in 100 people):

• Raised liver enzymes, usually without symptoms and monitored periodically.
• Headache.
• Dizziness.
• Skin rash or itching.

Serious Side Effects — Seek Urgent Medical Attention: Go to your nearest accident and emergency department or call 999 immediately if you experience severe muscle pain, weakness, or cramps, particularly with dark, tea coloured urine, which may indicate rhabdomyolysis (risk higher when combined with a statin); signs of significant liver problems such as yellowing of the skin or eyes, severe abdominal pain, or very dark urine; or signs of a severe allergic reaction such as sudden widespread rash, difficulty breathing, or swelling of the face, lips, tongue, or throat.

Bezalip tablets may be suitable if you:

• Are an adult with hyperlipidaemia, hypertriglyceridaemia, or mixed dyslipidaemia that has not been adequately managed by dietary measures alone.
• Have raised triglyceride levels as the primary lipid abnormality or as part of a mixed lipid disorder.
• Cannot tolerate statins or require additional lipid management alongside statin therapy, and your prescriber has assessed the risk of combination treatment.
• Are already prescribed bezafibrate and require a repeat prescription through an online prescribing service.

Bezalip tablets are not suitable if you:

• Have significant kidney impairment, as bezafibrate is substantially excreted by the kidneys and dose reduction or avoidance is required.
• Have significant liver disease or abnormal liver function tests.
• Have a history of photoallergy or phototoxicity from fibrate medicines.
• Have gallbladder disease, as fibrates increase the cholesterol content of bile and can raise the risk of gallstones.
• Are pregnant or planning to become pregnant. Effective contraception is required during treatment and for an appropriate period after stopping.
• Are breastfeeding.
• Are under 18 years of age.
• Have a known allergy or hypersensitivity to bezafibrate or any excipient listed in the SmPC.

Important Drug Interactions: Statins (atorvastatin, simvastatin, rosuvastatin) combined with bezafibrate increase the risk of myopathy and rhabdomyolysis and require careful prescriber assessment. Anticoagulants such as warfarin may have their effect enhanced — closer INR monitoring is needed. Antidiabetic medicines including insulin and sulphonylureas may have their blood glucose lowering effect enhanced, increasing hypoglycaemia risk. Ciclosporin may increase the risk of kidney impairment when combined with bezafibrate. Colestyramine and other bile acid sequestrants reduce bezafibrate absorption — take at least one hour before or four to six hours after.

Bezafibrate is a Prescription Only Medicine. The clinical consultation is the essential first step. A prescription will only be issued if a registered prescriber concludes, based on their individual assessment of your circumstances, that Bezalip is clinically appropriate for you.

During your online consultation with Pharmacy Planet, a registered prescriber will review your lipid profile, kidney function where available, liver function, current medicines, and other relevant medical history. The prescriber will assess whether bezafibrate is the right choice for your lipid management needs, whether the 400 mg modified release dose is appropriate, and whether online prescribing is suitable for your situation.

Not all consultations will result in a prescription. The prescriber may request recent blood test results, recommend a statin or a different approach to cholesterol management, or advise that a full lipid assessment by your GP is needed before prescribing proceeds.

If you are under the care of your GP or a specialist for lipid management or cardiovascular therapy, please keep them informed of all medicines prescribed through online services.