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BEZALIP MONO TABLETS 400MG

Active substance(s): BEZAFIBRATE

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352 LEAFLET Bezalip 20140416

PACKAGE LEAFLET: INFORMATION FOR THE USER



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.

BEZALIP MONO TABLETS 400mg
BEZALIP RETARD TABLETS 400mg
(bezafibrate)
Your medicine is known by either 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.


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.

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 colestyramine (used to lower
colesterol). Bezalip and an anion exchange resin should not be
taken within 2 hours of each other.

Index
1

What Bezalip is and what it is used for



statins e.g. atorvastatin (used to lower cholesterol).

2

Before you take



3

How to take

monoamine-oxidase inhibitors (MAOIs) e.g. phenelzine (used in
depression).

4

Possible side effects



oestrogen or medicines which contain oestrogen.

5

How to store

6

Further information

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

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.

Driving and using machines
Bezalip 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.

2. BEFORE YOU TAKE
Do not take Bezalip and tell your doctor if you:

Tests



are allergic (hypersensitive) to bezafibrate or any of the other
ingredients in the tablets (see section 6).

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



are allergic (hypersensitive) to fibrates or have developed a
sensitivity to sunlight or artificial light (e.g. sunbeds) when
taking these medicines.

3. HOW TO TAKE



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):

Swallow the tablets whole with water, after food in the morning
or evening.



impaired kidney function



an underactive thyroid (hypothyroidism)



severe infection



trauma

Doses:



surgery

Adults: One tablet a day (400mg bezafibrate a day).



a change in the levels of hormones or chemicals in your
body (seen in a blood test)



a high alcohol intake.

Elderly: Your doctor may reduce the dose depending on how well
your kidneys are working.
Children: Not recommended.



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 if
you:


Always take Bezalip exactly as your doctor has told you. If you are
not sure, check with your doctor or pharmacist.

Bezalip and an anion exchange resin should not be taken within 2
hours of each other.

Impaired kidney function: Do not take Bezalip 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 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).

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

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

5.

HOW TO STORE

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



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store the tablets above 25°C.



Do not use this medicine after the expiry date shown on the
blister strip and carton.

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.



If your doctor tells you to stop the treatment, take any leftover
tablets to the pharmacist. Only keep them if the doctor tells you
to.



gallstones: pain in the upper abdomen or yellowing of the skin
or whites of the eyes (jaundice).





abnormal muscle breakdown

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.

(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



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



Each tablet contains 400mg of the active ingredient,
bezafibrate.



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.



The tablets also contain lactose monohydrate, polyvidone K 25,
sodium lauryl sulphate, hypromellose, colloidal silicon dioxide,
magnesium stearate, Eudragit NE 30D, macrogol 10,000, talc,
titanium dioxide (E171), polysorbate 80 and sodium citrate.



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 is available as blister packs containing 30 tablets.



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 test.

What Bezalip contains

What Bezalip looks like and contents of the pack
Bezalip is a round, white, film-coated tablets marked ‘D9‘on one
side and plain on the other.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Cenexi SAS, France.
POM

PL No: 08747/0352

Leaflet revision date: 16 April 2014.
Bezalip is a registered trade mark of F Hoffmann-La Roche AG,
Switzerland.
352 LEAFLET Bezalip 20140416

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.

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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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