Skip to Content

CALBERZOL XL 400 MG PROLONGED-RELEASE TABLETS

Active substance(s): BEZAFIBRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Bezalip® Mono

2537
03.12.15[3]

(bezafibrate)
PATIENT INFORMATION LEAFLET
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.
This medication is available using as the above name but will be referred to
as Bezalip Mono throughout the following leaflet.
What is in this leaflet
1. What Bezalip Mono 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 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.
2. BEFORE YOU TAKE
Do not take Bezalip Mono 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 impaired kidney function.
Check with your doctor or pharmacist before taking Bezalip Mono 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 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 and breast-feeding
Speak to your doctor before taking Bezalip Mono during pregnancy or
breast-feeding.

Driving and using machines
Bezalip Mono 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.
3. HOW TO TAKE
Always take Bezalip Mono 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.
Bezalip Mono 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 Bezalip Mono 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, Bezalip Mono 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 (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 (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 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

PLPI 20636 / 2537

Leaflet revision and issue date (Ref) 03.12.15[3]
Bezalip Mono is a trademark of Actavis Deutschland GmbH & Co. KG.

Calberzol® XL 400 mg
Prolonged- Release Tablets

2537
03.12.15[3]

(bezafibrate)
PATIENT INFORMATION LEAFLET
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.
This medication is available using as the above name but will be referred to
as Calberzol XL throughout the following leaflet.
What is in this leaflet
1. What Calberzol XL 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 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.
2. BEFORE YOU TAKE
Do not take Calberzol XL 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 impaired kidney function.
Check with your doctor or pharmacist before taking Calberzol XL 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 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 and breast-feeding
Speak to your doctor before taking Calberzol XL during pregnancy or
breast-feeding.
Driving and using machines
Calberzol XL 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.
3. HOW TO TAKE
Always take Calberzol XL 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 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 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 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 (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 (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

PLPI 20636 / 2537

Leaflet revision and issue date (Ref) 03.12.15[3]
Calberzol is a trademark of Actavis Group PTC ehf.

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.

Hide