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CALBERZOL XL 400 MG PROLONGED-RELEASE TABLETS

Active substance(s): BEZAFIBRATE / BEZAFIBRATE / BEZAFIBRATE

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Bezalip® Mono

2537
23.05.17[5]

(bezafibrate)
PATIENT INFORMATION 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.
This medication is available using as the above name but will be referred to
as Bezalip Mono throughout the following leaflet.

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.

What is in this leaflet
1. What Bezalip Mono is and what it is used for
2. What you need to know before you take Bezalip Mono
3. How to take Bezalip Mono
4. Possible side effects
5. How to store Bezalip Mono
6. Contents of the pack and other information

Driving and using machines
Bezalip Mono may make you feel dizzy. Make sure you are not affected
before you drive or operate machinery.

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 non-medical
treatments such as exercise and weight loss, to lower levels of fats in the
blood.

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

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.

Bezalip Mono contains 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.

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, 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 MONO
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton
and blister strip. The expiry date refers to the last day of that month.
If your tablets become discoloured or shown any other sign of deterioration,
please contact your doctor or pharmacist before taking your medicine.
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 Mono contains
- The active substance is bezafibrate.
Each tablet contains 400mg of the active substance.
- The other ingredients are lactose monohydrate, povidone K25, sodium
laurilsulfate, hypromellose 3 mPa.S, hypromellose 100 mPa.S, silica
colloidal anhydrous, magnesium stearate, polyethylene glycol 10000, talc,
titanium dioxide (E171), polysorbate 80, sodium citrate dihydrate.
What Bezalip Mono looks like and contents of the pack
Bezalip Mono tablets are white, round, modified release tablet imprinted
with ‘D9’.
Available in blister packs of 30 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Cenexi S.A.S., 52, Rue Marcel et Jacques Gaucher,
94120 Fontenay-Sous-Bois, France.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636 / 2537

Leaflet revision and issue date (Ref) 23.05.17[5]
Bezalip Mono is a trademark of Actavis Deutschland GmbH & Co. KG.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

Calberzol® XL 400 mg
Prolonged- Release Tablets

2537
23.05.17[5]

(bezafibrate)
PATIENT INFORMATION 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.
This medication is available using as the above name but will be referred to
as Calberzol XL throughout the following leaflet.

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.

What is in this leaflet
1. What Calberzol XL is and what it is used for
2. What you need to know before you take Calberzol XL
3. How to take Calberzol XL
4. Possible side effects
5. How to store Calberzol XL
6. Contents of the pack and other information

Calberzol XL contains 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.

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 non-medical
treatments such as exercise and weight loss, to lower levels of fats in the
blood.

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.

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.

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

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, 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
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton
and blister strip. The expiry date refers to the last day of that month.
If your tablets become discoloured or shown any other sign of deterioration,
please contact your doctor or pharmacist before taking your medicine.
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 contains
- The active substance is bezafibrate.
Each tablet contains 400mg of the active substance.
- The other ingredients are lactose monohydrate, povidone K25, sodium
laurilsulfate, hypromellose 3 mPa.S, hypromellose 100 mPa.S, silica
colloidal anhydrous, magnesium stearate, polyethylene glycol 10000, talc,
titanium dioxide (E171), polysorbate 80, sodium citrate dihydrate.
What Calberzol XL looks like and contents of the pack
Calberzol XL tablets are white, round, modified release tablet imprinted with
‘D9’.
Available in blister packs of 30 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Cenexi S.A.S., 52, Rue Marcel et Jacques Gaucher,
94120 Fontenay-Sous-Bois, France.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 20636 / 2537

Leaflet revision and issue date (Ref) 23.05.17[5]
Calberzol is a trademark of Actavis Group PTC ehf.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 020 8423 2111 to obtain the
leaflet in a format suitable for you.

Expand Transcript

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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