Patient Product Information

Bezalip®

Bezafibrate

What you should know about Bezalip (bezafibrate)

Please read this carefully before you start to take your medicine. This leaflet provides a summary of the information available on your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

What is in your medicine?

The name of this medicine is Bezalip.

Each round white film-coated tablet contains 200mg bezafibrate.

Bezafibrate is one of a group of medicines known as lipid-lowering substances. The tablets also contain maize starch, microcrystalline cellulose, silica, colloidal hydrated, sodium starch glycolate, magnesium stearate (E572), polymethacrylic acid esters, lactose, macrogol 6,000, talc (E553b), kaolin, titanium dioxide (E171), polysorbate 80 and sodium citrate (E331). No synthetic colouring substances are present in the formulation.

What does your medicine do?

Bezalip is used to lower high levels of cholesterol and other fats (lipids) in the blood. These high levels themselves do not make people feel ill but might cause problems later on leading to heart disease or other illness.

Before you take your medicine

• Are you pregnant or breast feeding your baby?
• Do you suffer from liver, gall bladder or kidney problems including renal dialysis?
• Have you been allergic to similar medicines before or become sensitive to sunlight?
• Are you taking medicine for thrombosis (e.g. Warfarin), or antidepressant medicines (e.g. MAOIs)?
• Do you have to monitor your blood or urine glucose (sugar) levels due to diabetes?
• Are you taking any other medicines to lower blood fats (lipids/cholesterol) especially medicines known as Statins?
• Have you had an organ transplant and, if so, are you taking cyclosporin?
• Are you taking medicines that contain oestrogen (e.g. oral contraceptives)?

If the answer to any of these questions is YES, do not take Bezalip tablets before you have discussed this with your doctor.

Taking your medicine

The usual dose is one tablet three times each day. Your doctor may tell you to take fewer tablets each day to reduce your dose, especially if you are elderly, and it is important that you follow these instructions.

 

Please swallow the tablets whole with a drink of water after you have eaten.

If you do miss a dose, take a tablet as soon as you remember on that day. Continue the tablets as usual. If you take more tablets than the label tells you to (overdose), tell your doctor at once if you then feel unwell.

High cholesterol and other blood fats need long term treatment. Keep taking your medicine either until your doctor tells you to stop or if the tablets make you feel unwell.

Look at the label and follow your doctor's directions about what you eat, taking exercise, how much alcohol you may drink and when and how to take your medicine. Your pharmacist may also help if you are not sure.

Bezafibrate can cause dizziness and if you are affected you should not drive or operate machines.

After taking your medicine

These tablets may cause side effects in a few people. To begin with your stomach may feel full or you might feel sick (nausea), but this discomfort should go away in a few days.

You may get a headache or feel dizzy. If these effects are troublesome talk to your doctor.

You may develop a rash or become sensitive to light, if so, tell your doctor.

In very rare cases a rash may become severe. If this happens to you stop taking your medicine and tell your doctor immediately.

You might start to feel tired or in some cases notice you begin to bruise easily. Or you may notice that you have reduced urine output. If you have any of these effects, tell your doctor.

Bezalip could cause gallstones or make existing gallstones larger. If you have troublesome pain in the upper part of the stomach or yellowing of the skin (jaundice) while you are taking Bezalip tell your doctor.

A very few patients have had increased hair loss and in men, impotence has been reported, though this is uncommon and other causes are possible. These effects usually clear up rapidly once the tablets are stopped.

These tablets may cause muscle weakness, cramp or pain, especially in your arms or legs. There may be a greater risk of muscle damage (rhabdomyolysis) especially if you have kidney problems, hormone problems, severe infection or an underactive thyroid or if you drink a lot of alcohol. If this happens to you stop taking your medicine and tell your doctor immediately.

Your doctor may wish to test your blood from time to time.

Tell your doctor or pharmacist if you have any unwanted effects not mentioned in this leaflet.

Storing your medicine

• Keep this medicine in a safe place where children cannot reach it. Your medicines could harm them. Do not use this medicine after the expiry date shown on the blister strip and carton.
• If your doctor tells you to stop the treatment, take any leftover tablets to the pharmacist. Only keep them if the doctor tells you to.