Package leaflet: Information for the patient

Bezafibrate 200 mg Film-coated Tablets

Read all of this leaflet carefully before

you start taking this medicine because it

contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Bezafibrate is and what it is used for

2.    What you need to know before you take Bezafibrate

3.    How to take Bezafibrate

4.    Possible side effects

5.    How to store Bezafibrate

6.    Contents of the pack and other information

1.    What Bezafibrate is and what it is used for

Bezafibrate belongs to a group of medicines, commonly known as fibrates. These medicines are used to lower the level of fats (lipids) in the blood. For example the fats known as triglycerides.

Bezafibrate is used, alongside a low fat diet and other non-medical treatments such as exercise and weight loss, to lower levels of fats in the blood.

2.    What you need to know before you take Bezafibrate

Do not take Bezafibrate:

•    if you are allergic to bezafibrate or any of the other ingredients of this medicine (listed in section 6)

•    if you are allergic to other fibrates or have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking these medicines

•    if you have liver disease (but you can take bezafibrate if you just have more fat in your liver due to your raised levels of triclycerides)

•    if you have gall bladder disease with or without gall stones

•    if you have severe kidney problems or are on dialysis treatment

•    if you have nephrotic syndrome (a disorder where the kidneys have been damaged, causing them to leak protein from the blood into the urine)

•    if you are also taking a statin (medicine to lower cholesterol e.g. atorvastatin and have any of the conditions listed under 'Warnings and precautions; which may increase the risk of you developing muscle disease (weakness, wasting and pain known as myopathy).

Warnings and precautions

Talk to your doctor or pharmacist before taking Bezafibrate:

•    if you have poorly controlled diabetes mellitus (type II), an underactive thyroid (hypothyroidism), nephritic syndrome (a kidney disorder), a condition that affects the amount of protein in the blood (dysproteinemia), obstructive liver disease or regularly drink large amounts of alcohol

•    if you have any of the following that may increase the risk of you developing muscle disease (weakness, wasting and pain):

•    if you have mild to moderate kidney problems

•    a history or family history of muscle problems

•    a previous history of muscle pain or weakness when taking a fibrate or other lipid lowering drug

•    a severe infection

•    recovering from trauma or an operation

•    a change in the levels of hormones or chemicals in your body (seen in a blood test)

•    aged over 65 years

In some isolated cases, bezafibrate can lead to gallstones.

Bezafibrate should be used in addition to eating the correct diet, exercise, weight loss and the treatment of pre-existing problems of the metabolism in the body (e.g. diabetes, gout).

Routine Tests

If you have kidney problems, your doctor may want to monitor you regularly by carrying out tests.

Children and adolescents

Bezafibrate is not recommended for use in children and adolescents.

Other medicines and Bezafibrate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is especially if you are taking any of the following medicines:

•    coumarin-type anticoagulants (medicine used to thin the blood) such as warfarin as your dosage will need to be adjusted

•    antidiabetic medication including insulin

•    monoamine oxidase inhibitors (MAOI) for depression (e.g. phenelzine)

•    ion-exchange resin medicines such as colestyramine or colestipol to help reduce your cholesterol level, you should not take bezafibrate until at least 2 hours after taking the resin

•    medicines used to suppress the immune system such as ciclosporin

•    HMGCoA reductase inhibitors or statins (medicines used to reduce cholesterol e.g. atorvastatin). These increase the risk of serious myopathy (muscle disease).

Your doctor will monitor you for signs of myopathy. If you develop muscle weakness, wasting or pain, tell your doctor straight away. If you have a condition that further increases your risk of muscle disease, you should not take bezafibrate together with a statin (see section 'Do not take Bezafibrate')

•    if you are taking oestrogens or oestrogen-containing contraceptives (including the contraceptive pill or HRT).

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take bezafibrate if you are pregnant, think you may be pregnant or are planning to have a baby. If you become pregnant while you are taking bezafibrate you must stop taking the tablets immediately and tell your doctor.

Breast-feeding

Bezafibrate may reach your baby through the breast milk. Therefore, talk to your doctor before taking bezafibrate while breast-feeding.

Driving and using machines

Bezafibrate is not known to affect your ability to drive or use machines. However, some side effects such as dizziness may occasionally occur. If affected you should not drive or use machines.

Bezafibrate contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Bezafibrate

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults: One tablet (200 mg Bezafibrate) taken three times a day. At the start of treatment, your doctor may decide to increase your dose slowly in the first week to reduce the likelihood of stomach upset.

Older people: Your doctor may reduce the dose depending on how your kidneys are working.

Use in children and adolescents: Bezafibrate is not recommended in children and adolescents.

Kidney disease: If you have kidney problems your doctor may prescribe a lower dose to that stated above. The dose given will depend upon the severity of your kidney disease. Bezafibrate should not be given to patients on dialysis treatment.

Tablets should be swallowed whole with a small drink after a meal.

If you take more Bezafibrate than you should

If you (or someone else) accidentally take too many tablets, or you think a child may have swallowed any, contact your doctor or nearest hospital emergency department immediately for advice. Signs of an overdose include abnormal muscle breakdown (muscle pain or weakness, swelling) which can lead to kidney problems (rhabdomyolysis).

If you forget to take Bezafibrate

Unless it is nearly time for your next dose, take it as soon as you remember and then take the next dose at the right time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Bezafibrate

Do not stop or change your treatment before talking to your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Bezafibrate and contact your doctor or go to the nearest hospital emergency room immediately if you think you may have any of the following side effects:

Uncommon (may affect up to 1 in 100 people)

•    an allergic reaction (hypersensitivity): swelling of the face, lips, tongue or throat, narrowing of the airways causing difficulty breathing or swallowing, red itchy skin.

•    blocked bile flow (cholestasis): liver disease with itching, jaundice (yellowing of the skin and eyes) and dark urine

•    acute renal failure: kidney disease with little or no urine, drowsiness, nausea, vomiting, breathlessness.

•    muscle disease: muscle pain or weakness or very rarely wasting or swelling. This can develop into potentially life-threatening muscle damage known as rhabdomyolysis

Rare (may affect up to 1 in 1,000 people)

•    inflammation of the pancreas (pancreatitis): severe upper stomach pain, often with nausea and vomiting.

Very rare (may affect up to 1 in 10,000 people)

•    decreased levels of platelets in the blood causing a disorder characterised by bleeding, blood spots, bruising and discolouring of the skin (thrombocytopenic purpura) and/or changes in the numbers and types of your blood cells. If you notice increased bruising, suffer from nosebleeds, sore throats, more infections than usual, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want to check your blood (blood test)

•    gallstones: pain in the upper abdomen and feeling sick or yellowing of the skin or whites of the eyes (jaundice)

•    severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis: worsening of a skin rash or blistering and bleeding of the lips, mouth, eyes, nose and genitals and feeling feverish

•    inflammation in the lungs (interstitial lung disease): coughing, difficulty breathing, wheezing.

These are serious side effects. You may need medical attention.

Other side effects

Common (may affect up to 1 in 10 people)

•    loss of appetite.

•    Stomach upset or discomfort

Uncommon (may affect up to 1 in 100 people)

•    dizziness, headache

•    bloated feeling, feeling sick, diarrhoea, stomach pain, constipation, heartburn or indigestion (dyspepsia)

•    itchy swollen skin, rash, hair loss (alopecia), sensitivity to sunlight or artificial light (e.g. sunbeds)

•    muscle cramps

•    problems with getting or maintaining an erection (erectile dysfunction)

•    increased or decreased levels of certain enzymes within the body (seen in a blood test), increased blood levels of creatinine.

Rare (may affect up to 1 in 1,000 people)

•    numbness or weakness of the arms and legs (peripheral neuropathy)

•    tingling or numbness of the hands and feet.

•    depression

•    difficulty getting to sleep (insomnia)

Very rare (may affect up to 1 in 10,000 people)

•    decreased levels of platelets in the blood causing a disorder characterised by bleeding, blood spots, bruising and discolouring of the skin (thrombocytopenic purpura), changes in the numbers and types of your blood cells. If you notice increased bruising, suffer from nosebleeds, sore throats, more infections than usual, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want to check your blood (blood test)

•    decreased levels of the red blood pigment haemoglobin, changes in the numbers and types of your blood cells, increased levels of certain enzymes within the body (seen in a blood test)

•    circular, irregular, red patches on the skin of the hands and arms (erythema multiforme).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Bezafibrate

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date which is stated on the carton, foil or bottle after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Bezafibrate contains

The active substance is bezafibrate. Each tablet contains 200 mg bezafibrate.

The other ingredients are: Tablet core contains: silica, colloidal anhydrous; magnesium stearate; maize starch; cellulose, microcrystalline; povidone, purified talc; sodium starch glycolate. Tablet coat contains: hypromellose; lactose (see section 2 'Bezafibrate contains lactose'); macrogol; titanium dioxide (E171).

What Bezafibrate looks like and contents of the pack

Bezafibrate 200 mg Film-coated Tablets are white, round, with sides that curve outwards and marked "BZ" and "200" on one side and "G" on the other.

Bezafibrate is available in:

•    Blister strips of plastic/aluminium foil in a carton in packs of 84 and 100

•    Plastic (HDPP) containers with tamper-evident polyethylene caps in packs of 84 or 100

•    Plastic (HDPP) containers with tamper-evident and child-resistant polyethylene caps in packs of 84 or 100, which may contain an optional plastic spacer at the top of the pack.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer:

Generics [UK] Limited, Station Close,

Potters Bar, Hertfordshire, EN6 1TL,

United Kingdom.

Gerard Laboratories,

35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13,

Ireland.

This leaflet was last revised in 05/2015    587616

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