BEZAFIBRATE 200MG TABLETS

Active substance: BEZAFIBRATE

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SAP number

Not printable space
SAP number

51.6 mm

Bezalip®

Index
1 What Bezalip is and what
it is used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further 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 Before you take

Do not take Bezalip and tell your
doctor if you:

• are allergic (hypersensitive) to bezafibrate
or any of the other ingredients in the tablets
(see section 6).
• are allergic (hypersensitive) to fibrates or
have developed a sensitivity to sunlight or
artificial light (e.g. sunbeds) when taking
these medicines.
• 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.
• are having dialysis.
• have liver disease.
• have gall bladder disease.
• have nephrotic syndrome (a kidney
disorder).
• have severely impaired kidney function.

Check with your doctor or pharmacist
before taking Bezalip if you:

• have any of the following which may
increase the risk of you developing muscle
disease (weakness, wasting and pain):
- impaired kidney function
-  n underactive thyroid
a
(hypothyroidism)
- severe infection
- trauma
- surgery
-  change in the levels of hormones or
a
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.

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 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 and breast-feeding

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

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

Always take Bezalip exactly as your doctor has
told you. If you are not sure, check with your
doctor or pharmacist.
Swallow the tablets whole with water, after
food.
Bezalip and an anion exchange resin should not
be taken within 2 hours of each other.

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AAAE6470

Continued over page

Bezalip Tablets 200mg PIL - UK

colours/plates:
1. Black

item no:

AAAE6470

dimensions: 125 x 250

print proof no:

5

pharmacode:

origination date: 05.12.12

min pt size:

2.
3.
4.
5.
6.

originated by:
approved for print/date

81.6 mm

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.

R.Paul

revision date:

19.08.13

Technical Approval

revised by:

R.Paul

date sent: 05.12.12

supplier:

Cenexi

technically app. date: 17.12.12

Non Printing Colours
1.
2.
3.

250 mm

==

1.5 mm

(bezafibrate)

Doses:
Adults: Three tablets a day in divided doses
(600mg bezafibrate a day).
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 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 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

Like all medicine, Bezalip 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,
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: 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 (occurs in less than 1 in 10 users):
decreased appetite, stomach disorders.
• 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.
• 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.

• 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.
If you notice any side effects, they get worse, or if
you notice any not listed, please tell your doctor
or pharmacist.

5 How to Store

Keep out of the reach and sight 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.

6 Further information
What Bezalip contains

• The active substance (the ingredient that
makes the tablets work) is bezafibrate.
Each tablet contains 200mg of the active
substance.
• The 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 August 2013.

Continued top of next column
AAAE6470

Actavis, Barnstaple, EX32 8NS, UK

Bezalip Tablets 200mg PIL - UK

colours/plates:
1. Black

item no:

AAAE6470

dimensions: 125 x 250

print proof no:

5

pharmacode:

origination date: 05.12.12

min pt size:

3.
4.
5.
6.

originated by:
approved for print/date

2.

R.Paul

revision date:

19.08.13

Technical Approval

revised by:

R.Paul

date sent: 05.12.12

supplier:

Cenexi

technically app. date: 17.12.12

Non Printing Colours
1.
2.
3.

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.

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