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BEZALIP RETARD 400MG TABLETS

Active substance(s): BEZAFIBRATE

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Patient information leaflet

Bezalip® Mono
400mg Tablets
(bezafibrate)
This product is available as the above name but will be referred
to as Bezalip Mono throughout the remainder of this leaflet.
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
2
3
4
5
6

What Bezalip Mono is and what it is used for
What you need to know before you take Bezalip Mono
How to take Bezalip Mono
Possible side effects
How to store Bezalip Mono
Contents of the pack and other information
1

1 What Bezalip Mono is and what it is used for
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 nonmedical treatments such as exercise and weight loss, to
lower levels of fats in the blood.
2

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.
• 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
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 monohydrate
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 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 or pharmacist.
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 or search for
MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5

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/blister. 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.
If your medicine become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who will tell
you what to do.6

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 prolonged-release
tablet contains 400mg of bezafibrate.
The other ingredients are lactose monohydrate,
polyvidone K25, sodium lauryl sulfate, hypromellose,
colloidal silicon dioxide, magnesium stearate, polyacrylate
dispersion 30%, macrogol 10000, talc, titanium dioxide
E171, polysorbate 80 and sodium citrate.

What Bezalip Mono looks like and contents of the
pack
Bezalip Mono is a white, round, film-coated, prolongedrelease tablet embossed ‘D9’ on one side and plain on the
other side.
Bezalip Mono is available as blister packs of 30 tablets.
PL: 15814/1341

POM

Manufactured by CENEXI SAS, France.
Procured from within the EU and repackaged by the Product
Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial
Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 13.02.2018
Bezalip is registered trademark of Actavis Group PTC ehf,
Iceland.

To request a copy of this leaflet
in Braille, large print or audio
please call 01923 332 796.

Patient information leaflet

Bezalip® Retard
400mg Tablets
(bezafibrate)
This product is available as the above name but will be referred
to as Bezalip Retard throughout the remainder of this leaflet.
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
2
3
4
5
6

What Bezalip Retard is and what it is used for
What you need to know before you take Bezalip Retard
How to take Bezalip Retard
Possible side effects
How to store Bezalip Retard
Contents of the pack and other information
1

1 What Bezalip Retard is and what it is used for
Bezalip Retard 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 Retard 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

2 What you need to know before you take
Bezalip Retard
Do not take Bezalip Retard:
• 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
Bezalip Retard:
• 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 Retard should not be used in children.

Other medicines and Bezalip Retard
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 Retard 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 Retard may make you feel dizzy. Make sure you are
not affected before you drive or operate machinery.

Bezalip Retard contains lactose monohydrate
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 Bezalip Retard
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 Retard 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 Retard if you
have impaired kidney function or are having dialysis.

If you take more Bezalip Retard 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 Retard
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 or pharmacist.
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 or search for
MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5

5 How to store Bezalip Retard
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use Bezalip Retard after the expiry date stated on the
label/carton/blister. 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.
If your medicine become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who will tell
you what to do.6

6 Contents of the pack and other information
What Bezalip Retard contains



The active substance (the ingredient that makes the
tablets work) is bezafibrate. Each prolonged-release
tablet contains 400mg of bezafibrate.
The other ingredients are lactose monohydrate,
polyvidone K25, sodium lauryl sulfate, hypromellose,
colloidal silicon dioxide, magnesium stearate, polyacrylate
dispersion 30%, macrogol 10000, talc, titanium dioxide
E171, polysorbate 80 and sodium citrate.

What Bezalip Retard looks like and contents of the
pack
Bezalip Retard is a white, round, film-coated, prolongedrelease tablet embossed ‘D9’ on one side and plain on the
other side.
Bezalip Retard is available as blister packs of 30 tablets.
PL: 15814/1341

POM

Manufactured by CENEXI SAS, France.
Procured from within the EU and repackaged by the Product
Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial
Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 13.02.2018
Bezalip is registered trademark of Actavis Group PTC ehf,
Iceland.

To request a copy of this leaflet
in Braille, large print or audio
please call 01923 332 796.

Patient information leaflet

Calberzol® XL 400mg
Prolonged-Release
Tablets
(bezafibrate)
This product is available as the above name but will be referred
to as Calberzol XL throughout the remainder of this leaflet.
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
2
3
4
5
6

What Calberzol XL is and what it is used for
What you need to know before you take Calberzol XL
How to take Calberzol XL
Possible side effects
How to store Calberzol XL
Contents of the pack and other information
1

1 What Calberzol XL is and what it is used for
Calberzol XL 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.
Calberzol XL 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

2 What you need to know before you take
Calberzol XL
Do not take Calberzol XL:
• 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:
• 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
Calberzol XL should not be used in children.

Other medicines and Calberzol XL
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 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 may make you feel dizzy. Make sure you are
not affected before you drive or operate machinery.

Calberzol XL contains lactose monohydrate
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
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 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 if you
have impaired kidney function or are having dialysis.

If you take more Calberzol XL 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
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 or pharmacist.
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 or search for
MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects, you can help provide more
information on the safety of this medicine.
5

5 How to store Calberzol XL
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use Calberzol XL after the expiry date stated on the
label/carton/blister. 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.
If your medicine become discoloured or show signs of any
deterioration, consult your doctor or pharmacist who will tell
you what to do.6

6 Contents of the pack and other information
What Calberzol XL contains



The active substance (the ingredient that makes the
tablets work) is bezafibrate. Each prolonged-release
tablet contains 400mg of bezafibrate.
The other ingredients are lactose monohydrate,
polyvidone K25, sodium lauryl sulfate, hypromellose,
colloidal silicon dioxide, magnesium stearate, polyacrylate
dispersion 30%, macrogol 10000, talc, titanium dioxide
E171, polysorbate 80 and sodium citrate.

What Calberzol XL looks like and contents of the
pack
Calberzol XL is a white, round, film-coated, prolongedrelease tablet embossed ‘D9’ on one side and plain on the
other side.
Calberzol XL is available as blister packs of 30 tablets.
PL: 15814/1341

POM

Manufactured by CENEXI SAS, France.
Procured from within the EU and repackaged by the Product
Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial
Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 13.02.2018
Calberzol is registered trademark of Actavis Group PTC ehf,
Iceland.

To request a copy of this leaflet
in Braille, large print or audio
please call 01923 332 796.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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