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BEZAFIBRATE 200MG TABLETS

Active substance(s): BEZAFIBRATE / BEZAFIBRATE / BEZAFIBRATE

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Bezalip®
(bezafibrate)

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 nonmedical 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
• 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.

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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.

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Do not take Bezalip:

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.

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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

Warnings and precautions

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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.

26.3

SAP number

Bezafibrate(Bezalip) 200mg Film-coated tablet PIL - UK
item no:

AAAJ0762

dimensions: 148 x 210

print proof no:

5

pharmacode:

origination date: 02.06.15
approved for print/date

min pt size: 7pt

colours/plates:

1. Black
2
3
4
5
6

originated by:

DR

revision date:

28.07.16

Technical Approval

revised by:

DR

date sent: 06.06.15 +16.06.16

supplier:

Cenexi SAS

technically app. date: 20.06.16

Non Printing Colours

1. Profile Info
2.
3.

Version1 : 27.10.2015
Creation

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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).
• g
 allstones (very rare): pain in the upper abdomen or
yellowing of the skin or whites of the eyes (jaundice).
• a
 bnormal muscle breakdown (rhabdomyolysis) (very
rare): muscle pain or weakness, swelling.
• b
 lood 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.
• s erious 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).

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.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

6 Contents of the pack and other information
What Bezalip contains

• T he active substance (the ingredient that makes the
tablets work) is bezafibrate. Each tablet contains 200mg
of the active substance.
• T he other ingredients are:
Tablet core: maize starch, microcrystalline cellulose,
colloidal silicon dioxide, sodium starch glycollate,
magnesium stearate.
Film-coating: polyvinyl alcohol, titanium dioxide (E171),
macrogol, talc.

What Bezalip looks like and contents of the pack

Bezalip tablets are white round film-coated tablets.
Pack size is 100.
Marketing Authorisation Holder
Actavis Group PTC ehf,
Reykjavíkurvegi 76-78,
220 Hafnarfjordur,
Iceland.
Manufacturer
Cenexi,
52, Rue Marcel et Jacques Gaucher,
94120 Fontenay-Sous-Bois,
France.
This leaflet was last
revised in July 2016.
Actavis, Barnstaple, EX32 8NS, UK
SAP number
10

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AAAJ0762

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).

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3 How to take Bezalip

148x210 (2 pages)

Bar code:
type=128 C
colours/plates:
Bezafibrate(Bezalip) 200mg Film-coated tablet PIL - font
UK = C28P30C
- 35 pt
1. Black
value : the SAP number
2
item no:
dimensions: 148 x 210Height bars:
AAAJ0762
7.408 mm
3 mm
large
:
23.409
print proof no: 5
pharmacode:
4

origination date: 02.06.15
approved for print/date

min pt size: 7pt

5
6

originated by:

DR

revision date:

28.07.16

Technical Approval

revised by:

DR

date sent: 06.06.15 +16.06.16

supplier:

Cenexi SAS

technically app. date: 20.06.16

Non Printing Colours

1. Profile Info
2.
3.

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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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