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BEZAFIBRATE 200 MG FILM-COATED TABLETS

Active substance(s): BEZAFIBRATE

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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:

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• 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 oestrogencontaining contraceptives (including the
contraceptive pill or HRT).

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Package leaflet: Information for the patient

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.

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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 StevensJohnson 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.

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.

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)
This leaflet was last revised in 05/2015

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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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