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BEZALIP 200MG FILM-COATED TABLETS

Active substance(s): BEZAFIBRATE / BEZAFIBRATE / BEZAFIBRATE

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PATIENT INFORMATION LEAFLET
BEZALIP® 200mg FILM-COATED TABLETS / BEZAFIBRATE 200mg FILM-COATED TABLETS
(bezafibrate)
This medicine is available using any of the above names but will be referred to as Bezalip
throughout the following patient information leaflet.
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, pharmacist or nurse.

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, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Bezalip is and what it is used for
2. What you need to know before you take Bezalip
3. How to take Bezalip
4. Possible side effects
5. How to store Bezalip
6. Contents of the pack and other information
1. WHAT BEZALIP IS AND WHAT IT IS USED FOR
Bezalip 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 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 BEZALIP
Do not take Bezalip:
• if you are allergic (hypersensitive) to bezafibrate or any of the other ingredients in the tablets
(see section 6).
• if you are allergic (hypersensitive) to fibrates or have developed a sensitivity to sunlight or
artificial light (e.g. sunbeds) when taking these medicines.
• if you 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
- 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.
• if you are having dialysis.
• if you have liver disease.
• if you have gall bladder disease.
• if you have nephrotic syndrome (a kidney disorder).
• if you have severely impaired kidney function.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Bezalip:
• if you have an abnormal level of fats (lipids) in your blood caused by:
- uncontrolled type 2 diabetes mellitus,
- an underactive thyroid (hypothyroidism)
- nephrotic syndrome (a kidney disorder)
- an abnormal protein content in the blood
- obstructive liver disease
- medication
• if you have an alcohol addiction.
• 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.
Children and adolescents
Bezalip should not be used in children.
Other medicines and Bezalip
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. 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 colestyramine (used to lower cholesterol). Bezalip 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, breast-feeding and fertility
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.
Driving and using machines
Bezalip may make you feel dizzy. Make sure you are not affected before you drive or operate
machinery.
Tests
If you have impaired kidney function, your doctor may want to monitor you regularly by carrying
out tests.
3. HOW TO TAKE BEZALIP
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Swallow the tablets whole with water, after food.
Bezalip and an anion exchange resin should not be taken within 2 hours of each other.

The recommended dose is:
Adults: One tablet three times a day (600mg bezafibrate a day). Each tablet should be
swallowed whole with sufficient fluid after a meal.
Elderly: your doctor may reduce the dose depending on how your kidneys are working.
Children: Not recommended.
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 Bezalip 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 (rhabdomyolysis).
If you forget to take Bezalip
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.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you notice signs of:
• an allergic reaction (hypersensitivity) (uncommon): swelling of the face, lips, tongue or
throat, narrowing of the airways causing difficulty breathing or swallowing, skin reactions such
as pale or red irregular raised patches with severe itching, itching, sensitivity to sunlight or
artificial light (e.g. sun beds).
• gallstones (very rare): pain in the upper abdomen or yellowing of the skin or whites of the
eyes (jaundice).
• abnormal muscle breakdown (rhabdomyolysis) (very rare): muscle pain or weakness,
swelling.
• blood and lymphatic disorders (very rare): 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), 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.
• serious skin reactions (very rare): 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 (Stevens-Johnson Syndrome), severe rash involving reddening, peeling and swelling
of the skin that resembles severe burns (Toxic epidermal necrolysis).
Tell your doctor if you notice any of the following side effects or notice any other effects not
listed:
Common (may affect up to 1 in 10 people): decreased appetite, stomach disorders.
Uncommon (may affect up to 1 in 100 people): 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.
Rare (may affect up to 1 in 1000 people): damage to nerve endings causing tingling, pins and
needles, inflammation of the pancreas (pancreatitis), depression, difficulty sleeping.
Very rare (may affect up to 1 in 10,000 people): inflammation in the lungs (interstitial lung
disease) causing shortness of breath (which may get worse over time) or cough (usually dry and
non-productive).
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: 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 BEZALIP
• Keep out of the sight and reach of children.
• Do not store above 25°C.
• Do not use Bezalip after the expiry date stated on the label/carton/bottle. 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 the tablets become discoloured or show any other signs of deterioration, you should seek
the advice of your pharmacist who will advise you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Bezalip contains
• The active substance (the ingredient that makes the tablets work) is bezafibrate. Each filmcoated tablet contains 200mg Bezafibrate.
• The other ingredients are: maize starch, microcrystalline cellulose, colloidal silicon dioxide,
sodium starch glycollate, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171),
macrogol 3350, talc.
What Bezalip looks like and contents of the pack
Bezalip tablets are white round film-coated tablet marked ‘G6’ on one side and plain on the other
side.
Bezalip is available in blister packs of 60 and 100 tablets.
PL NO: 15814/0890

POM

Bezalip is manufactured by Cenexi SAS, Rue Marcel AND Jacques Gaucher, 52 (Fontenay Sous
Bois) F-94120, France and is procured from within the EU and repackaged by the Product
Licence holder: O.P.D. Laboratories Ltd., Colonial Way, Watford, Herts WD24 4PR.
Leaflet update and revision date (ref): 08.12.2016.
Bezalip is a registered Trade Mark of Actavis Deutschland GmbH & Co. KG, Germany.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.

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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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