BEZALIP 200 mg Film-Coated Tablets

Bezalip 200 mg film-coated tablets
bezafibrato

Pharmacotherapeutic category
Lipid-lowering agent.

Therapeutic indications
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, together with a low-fat diet and other non-medical treatments,
such as exercise and weight loss, to reduce the levels of fats in the blood.

Contraindications
Bezafibrato must not be administered to patients with:
liver disorders (with the exception of hepatic steatosis which is frequently associated
with hypertriglyceridemia);
diseases of the gallbladder with or without cholelithiasis;
renal insufficiency and patients undergoing dialysis;
concomitant treatment with HMG CoA reductase inhibitors (statins) in patients with
predisposing factors to myopathy (reduced renal function, severe infections, trauma,
surgical interventions or alterations of hormonal or electrolytic balance) (see Interactions);
established individual hypersensitivity to bezafibrato, other fibrates or any of the
excipients;
established photoallergic or phototoxic reactions to fibrates;
pregnancy and breastfeeding (see Pregnancy and breastfeeding)

Special precautions for use
Adherence to diet and other measures that improve lipid metabolism disorders such
as physical activity, weight loss and adequate treatment of other metabolic disorders
(e.g. diabetes, gout) is of paramount importance.
The patient's response to therapy should be monitored at regular intervals and the
treatment should be discontinued if an adequate response is not obtained within 3 or 4
months.
The indications for the use of bezafibrato in children should be considered with particular caution.
It is not possible to provide a precise dosage indication for children.
Since estrogens can cause an increase in lipid levels, the prescription of bezafibrato in
patients taking estrogens or estrogen-based contraceptives should be critically evaluated
individually.
In patients with hypoalbuminemia, for example in the presence of nephrotic syndrome, and in
patients with impaired renal function, renal function should be monitored regularly. In patients with existing renal impairment, acute renal failure may develop if dosage guidelines based on serum creatinine or creatinine clearance
detected are not strictly followed.
Muscle weakness, myalgia and muscle cramps, often accompanied by a considerable increase in
creatine kinase (CK), may occur. In rare cases, severe muscle damage (rhabdomyolysis) has been observed. In most cases, this syndrome has been the consequence of an overdose or inappropriate use of bezafibrato, most often
in the presence of impaired renal function.
Due to the risk of rhabdomyolysis, the administration of bezafibrato in concomitance with
HMG CoA reductase inhibitors should be limited to exceptional cases, where it is
strictly indicated. Patients treated with combination therapy should be
accurately informed about the symptoms of myopathy and kept under close monitoring. At the first signs of myopathy, combination therapy should be discontinued immediately.
Bezafibrato modifies the composition of bile. Occasionally, the development of gallstones has been reported. It is unclear whether long-term treatment with bezafibrato
increases the formation of gallstones, as has been observed with other drugs with
similar mechanisms of action, or whether pre-existing gallstones increase in volume during
treatment with bezafibrato.
Cholelithiasis cannot be excluded as a possible side effect of therapy with
bezafibrato and therefore, if symptoms and signs related to cholelithiasis occur, appropriate diagnostic procedures should be performed (see Undesirable effects).
When bezafibrato is administered in association with anion exchange resins (for
example, cholestyramine), the two drugs must be taken at least 2 hours apart.

Interactions
Inform your doctor or pharmacist if you are taking or have recently taken
any other medicines, even those without a prescription.
When bezafibrato is used simultaneously with other drugs or substances, the
following interactions must be taken into account:
bezafibrato may increase the activity of coumarin anticoagulants. Consequently, at the beginning of treatment with bezafibrato, the dose of the anticoagulant should be reduced by 30 – 50 %, which should then be adjusted based on coagulation parameters.
bezafibrato may increase the activity of sulfonylureas and insulin due to a
better utilization of glucose, with a simultaneous reduction in the need for insulin.
in isolated cases, in patients undergoing organ transplantation who were taking concomitant immunosuppressive treatment with bezafibrato, impaired renal function has been reported, even if reversible (accompanied by a
corresponding increase in serum creatinine levels). Therefore, these patients require careful monitoring of renal function and, if significant changes in laboratory parameters occur, bezafibrato should be discontinued if necessary.
when bezafibrato is used in concomitance with anion exchange resins (for
example, cholestyramine), at least a 2-hour interval should be ensured between
the administrations of the two drugs due to impaired absorption of
bezafibrato.
Perexiline hydrogen maleate or MAO inhibitors (potentially hepatotoxic) should not be administered together with bezafibrato.
the interaction between HMG-CoA reductase inhibitors (statins) and fibrates may be of varying nature and
intensity depending on the drugs administered. The pharmacodynamic interaction
between these two classes of drugs can increase the risk of myopathy (see
Contraindications).

Special warnings

Pregnancy and breastfeeding
In the absence of adequate clinical experience, bezafibrato is contraindicated in established or suspected pregnancy
and during breastfeeding.

Effects on ability to drive and operate machinery
Since the drug can occasionally cause dizziness and drowsiness, patients should be informed that caution is required when using machinery, including driving vehicles.

Dosage, method of administration and duration of treatment
Start with 3 film-coated tablets a day (1 after each main meal), swallowed whole with
a little liquid.
If favorable results are obtained, especially in patients with hypertriglyceridemia, a daily dose of 2 film-coated tablets can be tested, while in particularly resistant dyslipidemic forms, it is permissible to increase to 4-5 film-coated tablets.
Patients with gastric sensitivity
Bezafibrato should be administered with caution in patients with gastric sensitivity
(see Special precautions for use).
Patients with impaired renal function
Bezalip 200 mg is contraindicated in patients with impaired renal function (serum creatinine
> 6 mg/100 ml or creatinine clearance <15 ml min) (see contraindications).
Creatinine clearance is the most reliable parameter (especially in the elderly patient).
The use of bezafibrato is contraindicated in dialyzed patients (see Contraindications).
Elderly patients
Renal function is physiologically reduced with age. Treatment with bezafibrato
should therefore be evaluated on the basis of serum creatinine and
creatinine clearance values.

Duration of treatment
Treatment with bezafibrato is normally a long-term therapy.
If you have any doubts about the use of the medicine, consult your doctor or pharmacist.

Overdose
With the exception of rhabdomyolysis, no specific clinical picture of bezafibrato intoxication is known. In case of overdose, adequate symptomatic therapy should therefore be administered. There is no specific antidote.
In cases of rhabdomyolysis (predominantly in patients with impaired renal function), immediately discontinue the administration of bezafibrato and monitor
renal function carefully.
In case of accidental ingestion of an excessive dose of the medicine, immediately notify your doctor or go to the nearest hospital.

Undesirable effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The overall safety profile of bezafibrato is based on clinical data and post-marketing experience.
In the 48 clinical studies, a total of 3581 patients were enrolled. The side effects
observed during clinical development and subsequent use in clinical practice are
mainly gastrointestinal symptoms, usually transient and
rarely leading to discontinuation of the drug. Myopathy (rhabdomyolysis) is
observed mainly when dosage reduction was not implemented in
patients with impaired renal function. It is believed that none of the side effects
affect long-term safety, as they usually occurred within the first months of treatment and were transient or disappeared
upon discontinuation of the drug.
The following table reports the frequency of adverse drug reactions ( uncommon (  1/1,000 and <1/100), very rare (<1/10,000))

Changes in laboratory data
The following changes in laboratory data have been observed during clinical studies
and have also been reported after marketing:
decreased alkaline phosphatase (uncommon).
decreased gamma-glutamyl transferase (uncommon).
The decrease in gamma-glutamyl transferase and, in parallel, alkaline phosphatase can
be used as an indicator of patient compliance.
undesirable.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Shelf life and storage
Shelf life: see the expiry date indicated on the packaging.

Caution: do not use the medicine after the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging
correctly stored.
Keep the medicine out of the reach and sight of children.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

Composition
1 tablet contains: bezafibrato 200 mg.
Excipients: corn starch, pregelatinized starch, microcrystalline cellulose, colloidal anhydrous silica, sodium starch glycolate (Type A), magnesium stearate, polyvinyl alcohol, macrogol 3350,
titanium dioxide, talc

Pharmaceutical form and content
50 film-coated tablets.

Marketing authorization holder
AIC Holder: AUROBINDO PHARMA ITALIA SRL Via San Giuseppe 102, 21047 –Saronno
Varese

Manufacturer and final controller
Produced and controlled by:
Cenexi 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois (France)

Batch release:
Cenexi 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois (France)
July 2011

Bezalip 400 mg prolonged-release tablets
bezafibrato

Pharmacotherapeutic category
Hypolipidemic agent.

Therapeutic indications
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, together with a low-fat diet and other non-medical treatments,
such as exercise and weight loss, to reduce levels of fats in the blood.

Contraindications
Bezafibrato must not be administered to patients with:
liver disorders (with the exception of hepatic steatosis which is frequently associated
with hypertriglyceridemia);
diseases of the gallbladder with or without cholelithiasis;
renal insufficiency and patients undergoing dialysis;
concomitant treatment with HMG CoA reductase inhibitors (statins) in patients with
predisposing factors to myopathy (reduced renal function, severe infections, trauma,
surgical interventions or alterations of hormonal or electrolytic balance) (see Interactions);
established individual hypersensitivity to bezafibrato or other fibrates or to any of the
excipients;
established photoallergic or phototoxic reactions to fibrates;
pregnancy and breastfeeding (see Pregnancy and breastfeeding)

Precautions for use
Adherence to diet and other measures that improve lipid metabolism disorders such as
physical activity, weight loss and adequate treatment of other metabolic disorders
(e.g. diabetes, gout) is of paramount importance.
The patient's response to therapy should be monitored at regular intervals and the
treatment should be discontinued if an adequate response is not obtained within 3 or 4
months.
The indications for the use of bezafibrato in children should be considered with particular caution.
No precise dosage indication can be provided for children.
Since estrogens can determine an increase in lipid levels, the
prescription of bezafibrato in patients taking estrogens or estrogen-based contraceptives must be
critically evaluated individually.
In patients with hypoalbuminemia, for example in the presence of nephrotic syndrome, and in
patients with impaired renal function, renal function must be monitored regularly. In patients with
existing renal impairment, acute renal failure may develop if dosage guidelines based on
creatinine or creatinine clearance are not strictly followed.
Muscle weakness, myalgia and muscle cramps may occur, often accompanied
by a considerable increase in creatine kinase (CK). In rare cases, severe muscle damage (rhabdomyolysis) has been observed.
In most cases, this syndrome has been the consequence of an overdose or inappropriate use of
bezafibrato, most often
in the presence of impaired renal function.
Due to the risk of rhabdomyolysis, the administration of bezafibrato in concomitance with
HMG CoA reductase inhibitors must be limited to exceptional cases, in which it is
strictly indicated. Patients treated with combination therapy must be
accurately informed about the symptoms of myopathy and kept under close monitoring. At the
first signs of myopathy, combination therapy should be discontinued immediately.
Bezafibrato modifies the composition of bile. Occasionally, the
development of gallstones has been reported. It is unclear whether long-term treatment with
bezafibrato
increases the formation of gallstones, as has been observed with other drugs with
similar mechanisms of action, or whether pre-existing gallstones increase in volume during
treatment with bezafibrato.
Cholelithiasis cannot be excluded as a possible side effect of therapy with
bezafibrato and therefore, if symptoms and signs related to cholelithiasis occur, appropriate
diagnostic procedures should be performed (see Undesirable effects).

Interactions
Inform your doctor or pharmacist if you are taking or have recently taken
any other medicines, including those available without a prescription.
When bezafibrato is used simultaneously with other drugs or substances, the
following interactions must be taken into account:
bezafibrato may increase the activity of coumarin anticoagulants. Consequently, at the beginning of
treatment with bezafibrato, the dose of the anticoagulant should be reduced by 30 – 50 %, which should then be adjusted based on coagulation parameters.
Bezafibrato may increase the activity of sulfonylureas and insulin due to a
better utilization of glucose, with a simultaneous reduction in the need for insulin.
In isolated cases, in patients undergoing organ transplantation who were taking concomitant immunosuppressive treatment with bezafibrato, a
pronounced, although reversible, impairment of renal function has been reported (accompanied by a
corresponding increase in creatinine levels). Therefore, these patients require careful monitoring of renal function and, if significant changes in laboratory parameters occur, bezafibrato should be discontinued if necessary.
When bezafibrato is used in concomitance with anion exchange resins (for
example colestyramine), at least 2 hours should be ensured between administrations of the two drugs due to impaired absorption of
bezafibrato.
Perexiline hydrogen maleate or
MAO inhibitors (potentially hepatotoxic) should not be administered with bezafibrato.
The interaction between HMG-CoA reductase inhibitors (statins) and fibrates can be of varying nature
and intensity depending on the drugs administered. The pharmacodynamic interaction between these two classes of drugs can increase the risk of myopathy
(see Contraindications).

Special warnings
Bezalip 400 mg contains lactose: if you have established intolerance to certain sugars,
contact your doctor before taking this medicine.

Pregnancy and breastfeeding
In the absence of adequate clinical experience, bezafibrato is contraindicated in established or suspected pregnancy
and during breastfeeding.

Effects on ability to drive and operate machinery
Since the drug can occasionally cause dizziness and drowsiness, the
patients must be informed that caution is required when using machinery,
including driving vehicles.

Dosage, method and time of administration
1 tablet a day to be taken in the morning or evening with meals, swallowed
whole with sufficient liquid.
Patients with gastric sensitivity
Bezafibrato should be administered with caution in patients with gastric sensitivity
(see Precautions for use).
Patients with impaired renal function
Bezalip 400 mg is contraindicated in patients with impaired renal function (serum creatinine
> 1.5 mg/100 ml or creatinine clearance < 60 ml/min) (see Contraindications).
Creatinine clearance is the most reliable parameter (especially in the elderly patient).
The use of bezafibrato is contraindicated in dialyzed patients (see Contraindications).
Elderly patients
Renal function is physiologically reduced with age. Treatment with bezafibrato
should therefore be evaluated on the basis of serum creatinine values and
creatinine clearance.
Bezalip 400 mg should not be used in the elderly as creatinine clearance after 70 years of age is normally less than 60 ml/min.

Duration of treatment
Treatment with bezafibrato is normally a long-term therapy.
If you have any doubts about the use of the medicine, consult your doctor or pharmacist.

Overdose
With the exception of rhabdomyolysis, no specific clinical picture is known
of bezafibrato intoxication. In case of overdose, adequate symptomatic therapy should be administered.
There is no specific antidote.
In cases of rhabdomyolysis (predominantly in patients with impaired renal function), immediately discontinue the administration of bezafibrato and monitor
renal function carefully.
If you accidentally take an excessive dose of the medicine, immediately notify your doctor or go to the nearest hospital.

Undesirable effects
Like all medicines, this medicine can cause side effects, although not everyone
will experience them.
The overall safety profile of bezafibrato is based on clinical data and post-marketing experience.
In the 48 clinical studies, a total of 3581 patients were enrolled. The side effects
observed during clinical development and subsequent use in clinical practice are
mainly symptoms affecting the gastrointestinal tract, usually transient and
rarely leading to discontinuation of the drug. Myopathy (rhabdomyolysis) is
observed mainly when dosage reduction has not been implemented in
patients with impaired renal function. It is believed that none of the side effects
affect long-term safety, as they usually occurred within the first few months of treatment and were transient or disappeared
upon discontinuation of the drug.
The following table reports the frequency of adverse drug reactions (uncommon
(  1/1,000 and <1/100), very rare (<1/10,000))

Abnormalities in laboratory data
The following abnormalities in laboratory data have been observed during clinical studies
and have also been reported after marketing:
decreased alkaline phosphatase (uncommon).
Decreased gamma-glutamyl transferase (uncommon).
The reduction of gamma-glutamyl transferase and, in parallel, of alkaline phosphatase can
be used as an indicator of patient compliance
undesirable.
If any of these side effects worsen or if you notice any other side effects not listed in this leaflet, tell your doctor or pharmacist.

Shelf life and storage
Shelf life: see the expiry date indicated on the packaging.

Caution: Do not use the medicine after the expiry date indicated on the packaging.
The expiry date refers to the product in intact packaging
correctly stored.
Keep the medicine out of reach and sight of children.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

Composition
1 tablet contains: bezafibrato 400 mg.
Excipients: Lactose monohydrate, povidone K25, sodium lauryl sulfate, hypromellose 100 mPas,
colloidal anhydrous silica, magnesium stearate, poly (ethyl acrylate, methyl methacrylate), hypromellose 3
mPas, macrogol 10,000, talc, titanium dioxide, polysorbate 80, sodium citrate.

Pharmaceutical form and content
30 prolonged-release tablets.

Marketing authorisation holder
AUROBINDO PHARMA ITALIA SRL Via San Giuseppe 102, 21047 –Saronno Varese

Manufacturer and final control
Manufactured and controlled by:
Cenexi 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois (France)

Batch release:
Cenexi 52, Rue Marcel et Jacques Gaucher 94120 Fontenay-Sous-Bois (France)