Bezalip And Bezalip Retard Consumer Medicine Information

Bezafibrate

200mg tablets

400mg sustained release tablets

What is in this leaflet

This leaflet answers some common questions about BEZALIP tablets and BEZALIP retard tablets.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of your taking BEZALIP against the benefits expected for you.

If you have any concerns about this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What BEZALIP is used for

The name of this medicine is BEZALIP. It contains the active ingredient bezafibrate.

Bezafibrate belongs to a group of medicines known as lipid-lowering substances.

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.

Your doctor, however, may have prescribed BEZALIP for another purpose. Ask your doctor if you have any questions why BEZALIP has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you take BEZALIP

Do not take BEZALIP if:

  • you have gall bladder disease
  • you have liver disease
  • you have severe kidney disease
  • you are pregnant or breastfeeding
  • you have had an allergic reaction to BEZALIP or any other type of "fibrate" including a reaction to light, or any ingredients listed at the end of this leaflet.
  • the pack is damaged or shows signs of tampering.
  • the expiry date printed on the pack has passed.
    If the pharmacist has repacked the medicine for you, there may not be an expiry date on the pack. If you use this medicine after the expiry date has passed it may not work, or may have an unexpected effect.

If you are not sure if you should be taking BEZALIP, talk to your doctor.

Before you take BEZALIP you must tell your doctor if:

  1. you are allergic to any other medicines, foods, dyes or preservatives
  2. you have any other health problems including:
  • diabetes
  • gout.
  1. you are pregnant or intend to become pregnant
    You should not take BEZALIP if you are pregnant.
  2. you are breastfeeding or wish to breastfeed
    You should not take BEZALIP if you are breastfeeding.

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you have bought from a pharmacy, supermarket or health-food shop.

Some commonly used medicines that may interfere with BEZALIP are:

  • oral contraceptives containing oestrogen
  • medicines for diabetes including insulin and a group of medicines called sulphonylureas which include gliclazide (Diamicron), tolbutamide (Diatol), glibenclamide (Gliben) and glipizide (Glipid)
  • medicines for thinning the blood e.g. warfarin (Marevan, Coumadin)
  • perhexiline maleate (Pexsig), a medicine for angina (chest pain)
  • antidepressant medicines called monoamine oxidase inhibitors (MAOI's). Common MAOI's are phenelzine (Nardil) and tranylcypromine (Parnate)
  • a group of lipid-lowering agents called HMG CoA reductase inhibitors. Common HMG CoA reductase inhibitors are lovastatin, pravastatin, simvastatin (Zocor), atorvastatin (Lipitor) and cerivastatin
  • anion exchange resins such as colestipol (Colestid) and cholestyramine (Questran Light) can prevent BEZALIP from working if they are taken at the same time. These medicines should be taken at least 2 hours before or after BEZALIP is taken
  • Immunosuppressant agents for organ transplantation.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking BEZALIP.

If you have not told your doctor about any of the above, tell them before you start taking BEZALIP.

Use BEZALIP exactly as your doctor has prescribed.

How to take BEZALIP

How much to take

Your doctor will tell you how many BEZALIP tablets to take each day.

The usual dose of BEZALIP 200mg tablets is one tablet three times each day. Your doctor may tell you to take fewer tablets each day, especially if you have a good response to BEZALIP.

The usual dose of BEZALIP retard 400mg tablets is one tablet once a day.

If you have renal disease, your doctor will probably tell you to take fewer BEZALIP 200mg tablets than the usual dose.

How to take it

Swallow the tablets whole with a drink of water. Take the tablets with, or after, meals.

How long to take it

High cholesterol and other blood fats need long term treatment. Keep taking your medicine until your doctor tells you to stop.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember and then go back to taking it as you would normally.

While you are taking BEZALIP

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking BEZALIP.

Do not take any other medicines whether they require a prescription or not without first telling your doctor or pharmacist.

Make sure you follow your doctor's directions about what to eat, exercise and how much alcohol you may drink. Your pharmacist may also help if you are not sure.

Tell your doctor if you become pregnant while taking BEZALIP.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise your doctor may think that it was not effective and change your medicine unnecessarily.

Tell your doctor if you feel the tablets are not helping your condition.

Be sure to keep all of your appointments with your doctor so that your progress can be checked.

Things you must not do

Do not stop taking BEZALIP or lower the dose without first checking with your doctor. Do not let yourself run out of medicine over the weekend or on holidays.

Do not give BEZALIP to anyone else, even if their symptoms seem similar to yours.

Do not use BEZALIP to treat other complaints unless your doctor says to.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking BEZALIP.

BEZALIP may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. Your doctor may wish to test your blood from time to time.

Ask your doctor or pharmacist to answer any questions you may have.

If side effects do occur, they may be:

  • 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.
  • if you develop a rash or pains or weakness, especially in your arms or legs, or your skin becomes sensitive to light, tell your doctor.
  • you might start to feel tired or in some cases notice you begin to bruise easily. If so, tell your doctor.
  • high levels of blood fats (cholesterol) may cause gallstones. 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 small number of patients have had increased hair loss. In men, rare cases of impotence have been reported, although other causes are possible.

In general, most of these side effects clear up once the tablets are stopped.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

In case of an overdose

If you or another person have taken more than the recommended dose of BEZALIP, immediately telephone your doctor or National Poisons Information Centre (telephone 0800 POISON or 0800 764 766) for advice or go to your nearest Accident and Emergency centre. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy.

If you are not sure what to do, contact your doctor or pharmacist.

After taking BEZALIP

Storage

Keep BEZALIP in a cool, dry place where the temperature stays below 30C.

Do not store it, or any other medicine, in a bathroom or near a sink.

Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep BEZALIP in a safe place where children cannot reach it. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Keep your tablets in the carton until it is time to take them. If you take the tablets out of the blister or the carton they may not keep well.

Disposal

If your doctor tells you to stop taking BEZALIP, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What BEZALIP looks like

BEZALIP 200mg tablets are white, round tablets engraved BM on one face and G6 on the other.

BEZALIP retard 400mg tablets are white, round tablets engraved BM on one face and D9 on the other.

Ingredients

Active ingredient:

The active ingredient in BEZALIP is bezafibrate.

Each 200mg Bezalip tablet contains 200mg of bezafibrate.

Each 400mg Bezalip retard tablet contains 400mg of bezafibrate.

Inactive ingredients:

Bezalip 200mg tablets also contain maize starch, pregelatinised starch, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycollate, magnesium stearate, poly(ethylacrylate, methylmethacrylate), polysorbate 80, lactose, polyethylene glycol, talc, kaolin, titanium dioxide and sodium citrate.

Bezalip retard 400mg tablets also contain lactose, polyvidone "K 25", sodium lauryl sulphate, methylhydroxypropylcellulose, silica colloidal anhydrous, magnesium stearate, poly(ethylacrylate, methylmethacrylate), polyethylene glycol, talc, titanium dioxide, polysorbate 80, and sodium citrate.

This leaflet was prepared on 8 May 2001.

Reference: Roche UK patient leaflet July 1999, with updates from New Zealand data sheet dated 12 January 2001.