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BEZALIP

Active substance(s): BEZAFIBRATE / BEZAFIBRATE / BEZAFIBRATE

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Calberzol XL 400mg Prolonged-Release 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.
What is in this leaflet
1.
What Calberzol XL tablets are and what they are used for
2.
Before you take Calberzol XL tablets
3.
How to take Calberzol XL tablets
4.
Possible side effects
5.
How to store Calberzol XL tablets
6.
Contents of the pack and other 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.

2.
Before you take Calberzol XL tablets
Do not take Calberzol XL tablets :










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 impaired kidney function.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Calberzol XL tablets:




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 Calberzol XL tablets
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). 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, 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
Calberzol XL tablets may make you feel dizzy. Make sure you are not affected before you drive or operate
machinery.

Calberzol XL tablets contain 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.

How to take Calberzol XL tablets

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.
Calberzol XL tablets 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 Calberzol XL tablets if you have impaired kidney function or are having
dialysis.

If you take more Calberzol XL tablets 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 Calberzol XL 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.
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 (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.
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 Calberzol XL tablets

Keep out of the sight and reach 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.
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 Calberzol XL tablets contains



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 looks like and contents of the pack
Calberzol XL tablets 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 June 2016.

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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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