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BEZAFIBRATE TABLETS 200MG

Active substance(s): BEZAFIBRATE

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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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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