BEZALIP MONO 400MG TABLETS

Active substance: BEZAFIBRATE

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Patient information leaflet

Bezalip® Mono
(bezafibrate)
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 are the same as yours.
Index
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 called lipidregulating drugs, which lower high levels of cholesterol and
other fats (lipids) in the blood (hyperlipidaemia). This
reduces and prevents any long term effects associated
with hyperlipidaemia.
2. Before you take
Do not take Bezalip Mono and tell your doctor if you:
• 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
pain):
 Impaired kidney function
 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. Especially:
• 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 cholestyramine (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.
Tests
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
pharmacist.
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.
Doses:
Adults one tablet a day (400 mg bezafibrate a day).
Elderly: your doctor may reduce the dose
• Depending on how well your kidneys are working.
Children: not recommended.
Impaired kidney function: do not take Bezalip Mono if
you have impaired kidney function or are having dialysis.
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 or 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
(rhabdomyolysis).
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 time.
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:
• Common (occurs in less than 1 in 10 users):
Decreased appetite
• Uncommon (occurs in less than 1 in 100 users):
Dizziness, headache, bloated feeling, feeling sick,
diarrhoea, 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.
• Rare (occurs in less than 1 in 1,000 users):
Damage to nerve endings causing tingling, pins and
needles, inflammation of the pancreas (pancreatitis).
• 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 (thrombocytopenia 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 test.
If you notice any side effects, they get worse, or if you
notice any not listed, please tell your doctor or pharmacist.
5. How to store








Keep this medicine in a safe place where children
cannot reach it. Your medicine could harm them.
Do not use this medicine after the expiry date shown
on the blister strip and carton.
Do not store above 25°C. Store in a cool dry place.
Keep your medicine in the original packaging.
If your doctor tells you to stop the treatment, take any
leftover tablets to the pharmacist. Only keep them if
your doctor tells you to.
If the tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist who
will advise you what to do.
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.

6. Further information
The active substance is bezafibrate. Each tablet contains
400 mg of bezafibrate. The tablets also contain lactose,
povidone, sodium laurilsulfate, hypromellose, silica
colloidal hydrated, magnesium stearate (E572),
polymethacrylic acid esters, macrogol 10,000, talc
(E553b), titanium dioxide (E171), polysorbate 80 and

sodium citrate (E331). No synthetic colouring substances
are present in the formulation.
What Bezalip Mono looks like and contents of the pack
Each round white film-coated, modified release tablet is
marked ‘D9’ on one side and plain on the reverse. The
tablets are packed in blister strips and come in cartons of
30 tablets.
Manufacturer:
Cenexi 52, Rue Marcel et Jacques Gaucher
94120 Fontenay-Sous-Bois, France
Roche S.p.A. officina di Segrate (MI) – Via Morelli 2, Italy.
Procured within the EU
Re-packaged by the Product Licence Holder:
Munro Wholesale Medical Supplies Limited,
3 Young Place, East Kilbride G75 0TD.

PL 03243/0313

POM

Leaflet revision date: 28/05/2013
0313/8
Bezalip® is a registered trade mark of Actavis Deutschland GmbH
& Co. KG

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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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