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Active substance(s): BEZAFIBRATE

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Patient Information Leaflet

Bezalip® Mono
400 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

This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
The name of your medicine is Bezalip Mono 400 mg
Tablets, but it will be referred to as Bezalip Mono in this


1 What Bezalip Mono is and what it is
used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
1 What Bezalip Mono is and what it is used for
Bezalip Mono 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.
Bezalip mono 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 Before you take

Do not take Bezalip Mono and tell your doctor if
are allergic (hypersensitive) to bezafibrate or any of
the other ingredients in the tablets (see section 6).
are allergic (hypersensitive) to fibrates or have
developed a sensitivity to sunlight or artificial light
(e.g. sunbeds) when taking these medicines.
are taking statins (e.g. atorvastatin) and have any of
the following which may increase the risk of you
developing muscle disease (weakness, wasting and
- impaired kidney function
- an underactive 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.
are having dialysis.
have liver disease.
have gall bladder disease.
have nephrotic syndrome (a kidney disorder).
have impaired kidney function.

Check with your doctor or pharmacist
before taking Bezalip Mono if you:

have any of the following which may increase the
risk of you developing muscle disease (weakness,
wasting and pain):
- impaired kidney function
- an underactive 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
- are elderly (over 65 years old)
- have a family history of muscle disease.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
 coumarin-type anti-coagulants e.g. warfarin (used to
prevent blood clotting).
 antidiabetic medicines such as insulin
(used in diabetes).
 ciclosporin (used to suppress the immune system).
 anion exchange resins such as colestyramine (used
to lower cholesterol). Bezalip Mono and an anion
exchange resin should not be taken within 2 hours
of each other.
 statins e.g. atorvastatin (used to lower cholesterol).
 monoamine-oxidase inhibitors (MAOIs)
e.g. phenelzine (used in depression).
 oestrogen or medicines which contain oestrogen.

Pregnancy and breast-feeding
Speak to your doctor before taking Bezalip Mono during
pregnancy or breast-feeding.

Driving and using machines
Bezalip Mono may make you feel dizzy. Make sure you
are not affected before you drive or operate machinery.

Sugar intolerance
If you have been told you have an intolerance to some
sugars, contact your doctor before taking this medicine,
as it contains a type of sugar called lactose.

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

3 How to take
Always take Bezalip Mono exactly as your doctor has
told you. If you are not sure, check with your doctor or
Swallow the tablets whole with water, after food in the
morning or evening.
Bezalip Mono and an anion exchange resin should not
be taken within 2 hours of each other.

Adults: One tablet a day (400mg bezafibrate a day).
Elderly: Your doctor may reduce the dose depending
on how well your kidneys are working.
Children: Not recommended.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at: By reporting side effects,
you can help provide more information on the safety of
this medicine.

Impaired kidney function: Do not take Bezalip
Mono if you have impaired kidney function or are having

If you take more than you should
If you (or someone else) swallow a lot of tablets at the
same time, or you think a child may have swallowed
any contact your nearest hospital casualty department
or tell your doctor immediately. Signs of an overdose
include abnormal muscle breakdown (muscle pain or
weakness, swelling) which can lead to kidney problems

5 How to Store
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use Bezalip Mono after the expiry date stated on
the label/carton. The expiry date refers to the last day of
that month.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.
If Bezalip Mono show any other signs of deterioration,
you should seek the advice of your pharmacist who will
tell you what to do.

If you forget to take the tablets
Do not take a double dose to make up for a forgotten
dose. If you forget to take a dose take it as soon as you
remember it and then take the next dose at the right

4 Possible side effects
Like all medicine, Bezalip Mono can cause side effects,
although not everybody gets them.

Contact your doctor immediately if you notice
signs of:
an allergic reaction (hypersensitivity): swelling of
the face, lips, tongue or throat, itchy skin rash or
narrowing of the airways causing difficulty breathing
or swallowing.
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.

Tell your doctor if you notice any of the following
side effects or notice any other effects not listed:

6 Further information
What Bezalip Mono contains

The active substance (the ingredient that makes the
tablets work) is bezafibrate. Each modified release
tablet contains 400 mg bezafibrate.
The other ingredients are lactose monohydrate,
polyvidone K25, sodium laurylsulfate, hypromellose
2208, colloidal silicon dioxide, magnesium stearate,
macrogol 10000, talc , titanium dioxide (E171),
polysorbate 80, sodium citrate, polymethacrylate
dispersion, methocel K100.

Common (occurs in less than 1 in 10 users):
decreased appetite, stomach disorders.

What Bezalip Mono looks like and contents of
the pack

Uncommon (occurs in less than 1 in 100 users):
dizziness, headache, bloated feeling, feeling sick,
diarrhoea, stomach pain, constipation, indigestion,
blocked bile flow (cholestasis), itching, pale or red
irregular raised patches with severe itching (hives),
rash, sensitivity to sunlight or artificial light (e.g. sun
beds), hair loss (alopecia), 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.

Bezalip Mono are white round film-coated modified
release tablets, marked with 'D9' on one side and plain
on the other.

Rare (occurs in less than 1 in 1,000 users): damage
to nerve endings causing tingling, pins and needles,
inflammation of the pancreas (pancreatitis),
depression, difficulty sleeping.

Bezalip Mono 400 mg Tablets, PL 39352/0057

Very rare (occurs in less than 1 in 10,000 users):
inflammation in the lungs (interstitial lung disease),
decreased levels of platelets in the blood causing a
disorder characterised by blood spots, bruising and
discolouring to the skin (thrombocytopenic purpura),
decreased levels of the red blood pigment
haemoglobin, 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), severe form of skin rash
with flushing, fever, blisters or ulcers (StevensJohnson Syndrome), severe rash involving reddening,
peeling and swelling of the skin that resembles severe
burns (Toxic epidermal necrolysis), changes in the
numbers and types of your blood cells. If you notice
increased bruising, nosebleeds, sore throats,
infections, excessive tiredness, breathlessness on
exertion or abnormal paleness of the skin, you should
tell your doctor who may want you to have a blood

Leaflet date: 20.12.2013

Pack size is 30.
Manufactured by: Cenexi SAS, France.
Procured from within the EU & repackaged by
PL holder: Kosei Pharma UK Ltd, 956 Buckingham
Avenue, Slough Trading Estate, Slough, SL1 4NL.



Bezalip is a registered trademark of Actavis group of

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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.