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BEZALIP MONO TABLETS 400MG

Active substance(s): BEZAFIBRATE / BEZAFIBRATE / BEZAFIBRATE

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352 LEAFLET Bezalip 20170112

PACKAGE LEAFLET: INFORMATION FOR THE USER

BEZALIP MONO TABLETS 400mg

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Bezalip:


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 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.

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):

What is in this leaflet



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)

1

What Bezalip is and what it is used for

2

What you need to know before you take Bezalip



a high alcohol intake

3

How to take Bezalip



are elderly (over 65 years old)

4

Possible side effects



have a family history of muscle disease.

5

How to store Bezalip

6

Contents of the pack and other information

1.

WHAT BEZALIP IS AND WHAT IT IS USED FOR

Children and adolescents
Bezalip should not be used in children.

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.

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.

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):

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.



impaired kidney function



an underactive thyroid (hypothyroidism)



severe infection

Driving and using machines



trauma



surgery

Bezalip may make you feel dizzy. Make sure you are not affected
before you drive or operate machinery.



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



a high alcohol intake.

Bezalip contains lactose
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 are having dialysis.



if you have liver disease.



if you have gall bladder disease.

Tests



if you have nephrotic syndrome (a kidney disorder).



if you have impaired kidney function.

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 in the morning
or evening.

Bezalip and an anion exchange resin should not be taken within 2
hours of each other.
The recommended dose is:
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.
Impaired kidney function: Do not take Bezalip if you have
impaired kidney function or 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).

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.


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.



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.



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.

CONTENTS OF THE PACK AND OTHER INFORMATION

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.

HOW TO STORE BEZALIP

If you have any further questions on the use of this medicine, ask
your doctor, pharmacist or nurse.

What Bezalip contains


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

4.



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.

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:

What Bezalip looks like and contents of the pack



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.

Bezalip is a round, white, film-coated tablets marked ‘D9‘on one
side and plain on the other.



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 (may affect up to 1 in 10 people): decreased appetite,
stomach disorders.

Bezalip is available as blister packs containing 30 tablets.
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

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.

PL No: 08747/0352

Leaflet revision date: 12 January 2017.

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Bezalip is a registered trade mark of F Hoffmann-La Roche AG,
Switzerland.
352 LEAFLET Bezalip 20170112

Very rare (may affect up to 1 in 10,000 people): 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 (Stevens-Johnson 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.

Expand Transcript

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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