BEZALIP

Active substance: BEZAFIBRATE

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Calberzol XL 400mg
Prolonged-Release Tablets
(bezafibrate)
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.

Index
What Calberzol XL tablets are and
1 
what they are used for
2 Before you take
3 How to take
4 Possible side effects
5 How to store
6 Further information
1 What Calberzol XL tablets are and

what they are used for

Calberzol XL tablets belong 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.
Calberzol XL tablets are 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.

MOCK UP

2 Before you take
Do not take Calberzol XL tablets and tell your
ONLY
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 impaired kidney function.

Check with your doctor or pharmacist
before taking Calberzol XL tablets 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.

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). Calberzol XL tablets
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 Calberzol XL
during pregnancy or breast-feeding.

Driving and using machines

Calberzol XL tablets 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.

Tests

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

Continued top of next column
AAAE6473

Continued over page

Bezafibrate (Calberzol) Prolonged Release Tablets 400mg PIL - UK

colours/plates:
1. Black

item no:

AAAE6473

dimensions: 150 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.

3 How to take

Always take Calberzol XL tablets 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
in the morning or evening.
Calberzol XL tablets and an anion exchange resin
should not be taken within 2 hours of each other.
Doses:
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 Calberzol
XL tablets 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).

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, Calberzol XL tablets 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.

MOCK UP
ONLY

Tell your doctor if you notice any of the following
side effects or notice any other effects not listed:
•  ommon (occurs in less than 1 in 10 users):
C
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 of 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 for 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 throat, 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 use Calberzol XL tablets 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 Calberzol XL tablets contain

• The active substance (the ingredient that makes
the tablets work) is bezafibrate. Each tablet
contains 400mg of the active substance.
• The other ingredients are lactose, povidone,
sodium laurilsulfate, hypromellose, silica
colloidal hydrated, magnesium stearate (E572),
polymethacrylic acid esters, macrogol 10,000, talc
(E553b), titanium dioxide (E171), polysorbate 80,
sodium citrate (E331).

What Calberzol XL tablets look like and
contents of the pack

Calberzol XL tablets are white round film-coated
modified release tablets.
Pack size is 30.
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
AAAE6473

Actavis, Barnstaple, EX32 8NS, UK

Bezafibrate (Calberzol) Prolonged Release Tablets 400mg PIL - UK

colours/plates:
1. Black

item no:

AAAE6473

dimensions: 150 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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