BEZALIP RETARD TABLETS 400MG
Active substance(s): BEZAFIBRATE
PACKAGE LEAFLET: INFORMATION FOR THE USER
BEZALIP® RETARD TABLETS 400MG/
BEZALIP® MONO 400MG TABLETS
(bezafibrate)
Your medicine is available using the names Bezalip Retard Tablets
400mg or Bezalip Mono 400mg Tablets but will be referred to as
Bezalip throughout this 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.
Index
1.
2.
3.
4.
5.
6.
What Bezalip is and what it is used for
Before you take
How to take
Possible side effects
How to store
Further information
1. What Bezalip is and what it is used for
Bezalip 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. Before you take
Do not take Bezalip 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 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 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
Bezalip 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 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 can cause side effects, although not
everybody gets them.
Contact your doctor immediately if you notice signs
of:
Speak to your doctor before taking Bezalip during pregnancy or
breast-feeding.
Driving and using machines
Bezalip 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 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.
Page 1 of 2
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.
What Bezalip looks like and contents of the pack
Bezalip are white, film-coated, modified release tablets coded 'D9'
on one side and plain on the reverse.
Bezalip are available as blister packs of 30 tablets.
Manufacturer
This product is manufactured by: Cenexi SAS, France.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0334
POM
Leaflet revision and issue date (Ref.) 21.01.14
Bezalip® is a registered trademark of Actavis Deutschland GmbH
& Co. KG.
5. How to store
Do not store above 25°C.
Store in a dry place.
Keep out of the sight and reach of children.
Do not use after the expiry date printed on the carton label
or blister strip. The expiry date refers to the last date of that
month.
If your doctor tells you to stop taking the tablets, please
take them back to the pharmacist for safe disposal. Only
keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will advise you what to do.
Medicines must 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 contains
Each modified release tablet contains 400mg bezafibrate.
Bezalip also contain the following:
lactose monohydrate, polyvidone K25, sodium lauryl sulphate,
hypromellose, magnesium stearate, macrogol 10000,
Eudragit NE 30D, colloidal silicon dioxide, talc,
titanium dioxide (E171), polysorbate 80 and sodium citrate.
Page 2 of 2
BEZALIP® RETARD TABLETS 400MG/
BEZALIP® MONO 400MG TABLETS
(bezafibrate)
Your medicine is available using the names Bezalip Retard Tablets
400mg or Bezalip Mono 400mg Tablets but will be referred to as
Bezalip throughout this 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.
Index
1.
2.
3.
4.
5.
6.
What Bezalip is and what it is used for
Before you take
How to take
Possible side effects
How to store
Further information
1. What Bezalip is and what it is used for
Bezalip 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. Before you take
Do not take Bezalip 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 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 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
Bezalip 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 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 can cause side effects, although not
everybody gets them.
Contact your doctor immediately if you notice signs
of:
Speak to your doctor before taking Bezalip during pregnancy or
breast-feeding.
Driving and using machines
Bezalip 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 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.
Page 1 of 2
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.
What Bezalip looks like and contents of the pack
Bezalip are white, film-coated, modified release tablets coded 'D9'
on one side and plain on the reverse.
Bezalip are available as blister packs of 30 tablets.
Manufacturer
This product is manufactured by: Cenexi SAS, France.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0334
POM
Leaflet revision and issue date (Ref.) 21.01.14
Bezalip® is a registered trademark of Actavis Deutschland GmbH
& Co. KG.
5. How to store
Do not store above 25°C.
Store in a dry place.
Keep out of the sight and reach of children.
Do not use after the expiry date printed on the carton label
or blister strip. The expiry date refers to the last date of that
month.
If your doctor tells you to stop taking the tablets, please
take them back to the pharmacist for safe disposal. Only
keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist
who will advise you what to do.
Medicines must 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 contains
Each modified release tablet contains 400mg bezafibrate.
Bezalip also contain the following:
lactose monohydrate, polyvidone K25, sodium lauryl sulphate,
hypromellose, magnesium stearate, macrogol 10000,
Eudragit NE 30D, colloidal silicon dioxide, talc,
titanium dioxide (E171), polysorbate 80 and sodium citrate.
Page 2 of 2
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