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BEZALIP 200 MG TABLETS

Active substance(s): BEZAFIBRATE / BEZAFIBRATE

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Bezalip® 200 mg Tablets

2536
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 throughout the following leaflet.
What is in this leaflet
1. What Bezalip is and what it is used for
2. What you need to know before you take Bezalip
3. How to take Bezalip
4. Possible side effects
5. How to store Bezalip
6. Contents of the pack and other 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 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BEZALIP
Do not take Bezalip:
- 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 severely impaired kidney function.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Bezalip:
- 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 should not be used in children.

Other medicines and Bezalip
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 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 may make you feel dizzy. Make sure you are not affected before
you drive or operate machinery.
Tests
If you have impaired kidney function, your doctor may want to monitor you
regularly by carrying out tests.
3. HOW TO TAKE BEZALIP
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.
Bezalip and an anion exchange resin should not be taken within 2 hours of
each other.
The recommended dose is:
Adults: One tablet three times a day (600mg bezafibrate a day). Each tablet
should be swallowed whole with sufficient fluid after a meal.
Elderly: your doctor may reduce the dose depending on how your kidneys
are working.
Children: Not recommended.
Impaired kidney function: If you have impaired kidney function, your
doctor may give you a different dose, especially if you are having dialysis.
If you take more Bezalip 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
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) (uncommon) : swelling of the
face, lips, tongue or throat, narrowing of the airways causing difficulty
breathing or swallowing, skin reactions such as pale or red irregular raised
patches with severe itching, itching, sensitivity to sunlight or artificial light
(e.g. sun beds).
- gallstones (very rare): pain in the upper abdomen or yellowing of the
skin or whites of the eyes (jaundice).
- abnormal muscle breakdown (rhabdomyolysis) (very rare): muscle
pain or weakness, swelling.
- blood and lymphatic disorders (very rare): 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), 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.

- serious skin reactions (very rare): 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).
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) causing shortness of breath (which may get worse
over time) or cough (usually dry and non-productive).
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
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.
Do not store above 25°C.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Bezalip contains
- The active substance is bezafibrate.
Each tablet contains 200mg of the active substance.
- The other ingredients are:
Tablet core: maize starch, microcrystalline cellulose, colloidal silicon dioxide,
sodium starch glycollate, magnesium stearate and pregelatinised starch.
Film-coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
What Bezalip looks like and contents of the pack
Bezalip tablets are white round film-coated tablet imprinted with G6 and
plain on the other.
Available in blister packs of 20, 60 and 100 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 20636/2536

Leaflet revision and issue date (Ref) 23.05.17[5]
Bezalip 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.

Bezafibrate 200 mg Tablets

2536
23.05.17[5]

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 Bezafibrate throughout the following leaflet.
What is in this leaflet
1. What Bezafibrate is and what it is used for
2. What you need to know before you take Bezafibrate
3. How to take Bezafibrate
4. Possible side effects
5. How to store Bezafibrate
6. Contents of the pack and other information
1. WHAT BEZAFIBRATE IS AND WHAT IT IS USED FOR
Bezafibrate 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.
Bezafibrate 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. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BEZAFIBRATE
Do not take Bezafibrate:
- 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 takin 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 severely impaired kidney function.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Bezalip:
- 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 should not be used in children.

Other medicines and Bezafibrate
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).
Bezafibrate 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
Bezafibrate may make you feel dizzy. Make sure you are not affected before
you drive or operate machinery.
Tests
If you have impaired kidney function, your doctor may want to monitor you
regularly by carrying out tests.
3. HOW TO TAKE BEZAFIBRATE
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.
Bezafibrate and an anion exchange resin should not be taken within 2 hours
of each other.
The recommended dose is:
Adults: One tablet three times a day (600mg bezafibrate a day). Each tablet
should be swallowed whole with sufficient fluid after a meal.
Elderly: your doctor may reduce the dose depending on how your kidneys
are working.
Children: Not recommended.
Impaired kidney function: If you have impaired kidney function, your
doctor may give you a different dose, especially if you are having dialysis.
If you take more Bezafibrate 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 Bezafibrate
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) (uncommon): swelling of the
face, lips, tongue or throat, narrowing of the airways causing difficulty
breathing or swallowing, skin reactions such as pale or red irregular raised
patches with severe itching, itching, sensitivity to sunlight or artificial light
(e.g. sun beds).
- gallstones (very rare): pain in the upper abdomen or yellowing of the
skin or whites of the eyes (jaundice).
- abnormal muscle breakdown (rhabdomyolysis) (very rare): muscle
pain or weakness, swelling.
- blood and lymphatic disorders (very rare): 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), 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.

- serious skin reactions (very rare): 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).
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) causing shortness of breath (which may get worse
over time) or cough (usually dry and non-productive).
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 BEZAFIBRATE
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.
Do not store above 25°C.
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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Bezafibrate contains
- The active substance is bezafibrate.
Each tablet contains 200mg of the active substance.
- The other ingredients are:
Tablet core: maize starch, microcrystalline cellulose, colloidal silicon dioxide,
sodium starch glycollate, magnesium stearate and pregelatinised starch.
Film-coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
What Bezafibrate looks like and contents of the pack
Bezafibrate tablets are white round film-coated tablet imprinted with G6 and
plain on the other.
Available in blister packs of 20, 60 and 100 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 20636/2536

Leaflet revision and issue date (Ref) 23.05.17[5]

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 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.

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