Skip to Content

BEZALIP MONO 400 MG TABLETS

Active substance(s): BEZAFIBRATE / BEZAFIBRATE / BEZAFIBRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Patient Information Leaflet

Bezalip® Mono
400 mg Tablets
(bezafibrate)
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.

The name of your medicine is Bezalip Mono 400 mg
Tablets, but it will be referred to as Bezalip Mono in this
leaflet.

What is in this leaflet
1

What Bezalip Mono is and what it is
used for

2

What you need to know before you
take Bezalip Mono

3
3
4

How to take Bezalip Mono

5

How to store Bezalip Mono

6

Contents of the pack and other
information

Possible side effects







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 impaired kidney function.

Warnings and precautions
Talk to your doctor, pharmacist or
nurse before taking Bezalip Mono:
 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 Mono should not be used in children.

Other medicines and Bezalip Mono

What Bezalip Mono is and what it is used
for

1

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 What you need to know before you take

Bezalip Mono
Do not take Bezalip Mono:




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.

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

Bezalip Mono 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.

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

3
3

How to take Bezalip Mono
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 Mono 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
Mono if you have impaired kidney function or are having
dialysis.

If you take more Bezalip Mono 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 Mono
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): 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 (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),
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.
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 Mono
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.

6 Contents of the pack and other 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.

What Bezalip Mono looks like and contents of
the pack
Bezalip Mono are white round film-coated modified
release tablets, marked with 'D9' on one side and plain
on the other.
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® Mono 400 mg Tablets
PL 39352/0057

POM

Bezalip® is a registered trademark of Actavis group of
companies.
Leaflet date: 22/11/2016

Expand view ⇕

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.

Hide