Skip to Content

BEZAFIBRATE 200 MG TABLETS

Active substance(s): BEZAFIBRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Bezalip® 200 mg Tablets

2536
04.01.16[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 throughout the following leaflet.
What is in this leaflet
1. What Bezalip 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 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. 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 severely 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
Speak to your doctor before taking Bezalip during pregnancy or breastfeeding.

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
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.
Bezalip and an anion exchange resin should not be taken within 2 hours of
each other.
Doses:
Adults: Three tablets a day in divided doses (600mg bezafibrate a day).
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 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:
- an allergic reaction (hypersensitivity): 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: 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.
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. FURTHER 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

PLPI 20636 / 2536

Leaflet revision and issue date (Ref) 04.01.16[3]
Bezalip is a trademark of Actavis Deutschland GmbH & Co. KG.

Bezafibrate 200 mg Tablets

2536
04.01.16[3]

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 Bezafibrate throughout the following leaflet.
What is in this leaflet
1. What Bezafibrate 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 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. BEFORE YOU TAKE
Do not take Bezafibrate 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 severely impaired kidney function.
Check with your doctor or pharmacist
before taking Bezafibrate 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).
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 and breast-feeding
Speak to your doctor before taking Bezafibrate during pregnancy or breastfeeding.

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
Always take Bezafibrate 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.
Bezafibrate and an anion exchange resin should not be taken within 2 hours
of each other.
Doses:
Adults: Three tablets a day in divided doses (600mg bezafibrate a day).
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 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, Bezafibrate 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, 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: 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.
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. FURTHER 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

PLPI 20636 / 2536

Leaflet revision and issue date (Ref) 04.01.16[3]

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