Patient Product Information

Roche

Bezalip® Mono

Bezafibrate

What is in your medicine?

The name of this medicine is Bezalip Mono.

Each round white film-coated, modified release tablet contains 400mg bezafibrate.

Bezafibrate is one of a group of medicines known as lipid-lowering substances. The tablets also contain lactose, povidone, sodium laurilsulfate, hypromellose, silica colloidal hydrated, magnesium stearate (E572), polymethacrylic acid esters, macrogol 10,000, talc (E553b), titanium dioxide (E171), polysorbate 80 and sodium citrate (E331). No synthetic colouring substances are present in the formulation.

What does your medicine do?

Bezalip Mono 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 Mono tablets before you have discussed this with your doctor.

Taking your medicine

The dose is one tablet each day.

Please swallow the tablet 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. Take the next tablet the next day 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 to your doctor immediately.

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

Bezalip Mono 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 Mono tell your doctor.

A very few people have had increased hair loss and in men, rare cases of impotence have been reported, although other causes are possible. These effects usually clear up 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.