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Bezafibrate Tablets 200mg

Document: leaflet MAH GENERIC_PL 10622-0042 change

Patient Information Leaflet BEZAFIBRATE 200 mg TABLETS

Read all of this leaflet carefully before you start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms arethe same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed inthis leaflet, please tell your doctor or pharmacist.

1.    What Bezafibrate Tablets are and what they are used for

2.    Before you take Bezafibrate Tablets

3.    How to take Bezafibrate Tablets

4.    Possible side effects

5.    How to store Bezafibrate Tablets

6.    Further information

1. What Bezafibrate tablets are and what they are used for

Bezafibrate tablets contain the active ingredient Bezafibrate, which is a lipid lowering substance. Bezafibrate tablets are used to lower high levels of cholesterol and other fats (lipids) in the blood. If untreated, these high levels might cause problems later on leading toheart disease or other illness. Bezafibrate tablets should only be used for patients with high lipids that are uncontrolled by diet, exercise and weight reduction.

2. Before you take Bezafibrate tablets

Do NOT take Bezafibrate Tablets:

•    if you are allergic (hypersensitive) to Bezafibrate or any of the other ingredients of Bezafibrate tablets (see list of ingredients in Section 6)

•    If you are allergic (hypersensitive) to fibrates or have developed a sensitivity to sunlight or artificial light (e.g. sun beds) when taking these medicines

•    If you are taking statins and have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain):

-    impaired kidney function

-    an under active thyroid (hypothyroidism)

-    severe infection

-    trauma -surgery

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

-a high alcohol intake -age is over 65

-family history of muscle disorders

-suffered from muscle disease due to other blood lipid lowering drugs or fibrate

•    if you are having dialysis

•    if you have severe liver or kidney disorder (nephrotic syndrome)

•    if you have gall bladder disease.

Patient’s should be monitored closely as they may get muscle disease e.g. muscle weakness, muscle damage or muscle pain.

Take special care while receiving Bezafibrate:

If any of the following apply to you, tell your doctor, nurse or pharmacist as soon as possible:

•    if you have problem with some sweet ingredients (glucose, galactose)

•    if you are developing any type of muscle disease after starting Bezafibrate.

•    if you are having abdominal bloating, intolerance of fatty foods, indigestion and wind after starting treatment with Bezafibrate. These could be the symptoms of developing gallstone.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription:

•    anticoagulants (prevent clotting or thickening of the blood, for example warfarin)

•    antidiabetic medicines such as insulin and other treatments that reduce the level of fats in the blood such as ‘statins’ (e.g. simvastatin, pravastatin, atorvastatin) or ion-exchange resin (e.g. colestyramine). Bezafibrate and an anion exchange resin should not be taken within 2 hours of each other

•    monoamine oxidase inhibitors (treatments for depression)

•    oestrogens which are in medicines including HRT (hormone replacement therapy) and the Pill

•    cyclosporin (used to suppress the immune system).

Pregnancy and breast-feeding

You should not take Bezafibrate tablets while pregnant or breast-feeding. Speak to your doctor before taking any medicine.

Important information about some of the ingredients of Bezafibrate tablets

Bezafibrate tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Tests

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

3. How to take Bezafibrate tablets

Always take Bezafibrate tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

Bezafibrate tablets should always be taken with food and swallowed whole with a little water.

Adults and elderly patients

The usual dose is three tablets daily (600 mg Bezafibrate).

Children

There is no recommended dose for children.

Treatment may be stopped if your lipid levels have not been lowered within 3 to 4 months.

Impaired kidney function:

If you have impaired kidney function, your doctor may give you a different dose, especially if you are having dialysis.

If you take more Bezafibrate Tablets than you should:

It is important to stick to the dose on the label of your medicine. If you or someone else takes too many Bezafibrate tablets all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the medicine.

If you forget to take Bezafibrate Tablets

If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose if it is almost time for your next dose. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bezafibrate tablets can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare.

Tell your doctor straight away if you get:

•    an allergic reaction (hypersensitivity): any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body)

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

•    abnormal muscle breakdown (rhabdomyolysis): muscle pain or weakness, swelling.

The following side effects have been reported:

Common side effects (occurring in more than 1 in 100 patients but in less than 10 in 100 patients):

decreased appetite.

Uncommon side effects (occurring in more than 1 in 1000 patients but in less than 10 in 1000 patients):

•    swelling of the face, lips, tongue or throat, itchy skin rash or narrowing of the airways causing difficulty breathing or swallowing

•    dizziness, headache

•    feeling unwell, loose stools, bloated feeling

•    blocked bile flow

•    itching, pale or red irregular raised patches with severe itching (hives), rash sensitivity to sunlight or artificial light (e.g. sun beds)

•    hair loss

•    muscle weakness, cramps or pain (myalgia)

•    acute kidney failure

•    erection problems

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

Rare side effects (occurring in more than 1 in 10,000 patients but in less than 10 in 10,000 patients):

•    abnormal sensation of skin

•    numbness, tingling, burning and weakness of hands and feet

•    inflammation of the pancreas, which causes severe pain in the abdomen and back.

Very rare side effects (occurring in less than 1 in 10,000 patients):

•    severe reduction in blood cells and blood platelets which can cause weakness, bruising or make infections more likely

•    bruise like rash

•    gallstones

•    rash

•    serious illness with blistering of the skin, mouth, eyes and genitals

•    abnormal muscle breakdown

•    lung disease

•    changes in the numbers and types of your blood cells

•    abnormal liver function test.

Side effects with frequency not known:

•    tiredness.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    How to store Bezafibrate tablets

Do not store above 25°C. Store in the original container.

Keep out of the sight and reach of children.

Do not use Bezafibrate tablets after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer needed. These measures will help to protect the environment.

6.    Further information What Bezafibrate Tablets contain:

The active substance is Bezafibrate 200 mg. Bezafibrate Tablets also contain:microcrystalline cellulose, anhydrouslactose, sodium starch glycolate, calcium hydrogen phosphate dihydrate, maize starch, povidone, magnesium stearate,talc, colloidal anhydrous silica.The tablets are film coated with Opadry White YS-1-7003 which contains titanium dioxide (E171), hypromellose, macrogol400 and polysorbate 80.

What Bezafibrate Tablets look like and contents of the pack

Tablets are white, round and marked ‘BZ’ on one side and ‘200’ on the other.

Blister packs of 28, 30, 56, 84, 90, 100, 112 or 120 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

PLIVA Pharma Ltd., Vision House,

Bedford Road, Petersfield, Hampshire,

GU32 3QB, United Kingdom.

Manufacturer:

TEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised in November 2010

PL 10622/0042