1. NAME OF THE MEDICINAL
LIPANTHYL PENTA 145, film-coated
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 145.0 mg fenofibrate (nanoparticles).
For excipients, see section 6.1.
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
Hypercholesterolaemia and hypertriglyceridaemia alone or combined (type IIa,
IIb, III, IV and V dyslipidaemias) in patients unresponsive to dietary and
other non-drug therapeutic measures (e.g. weight reduction or increased
physical activity), particularly when there is evidence of associated risk
The treatment of secondary hyperlipoproteinaemia is indicated if the
hyperlipoproteinaemia persists despite effective treatment of the underlying
disease (e.g.dyslipidaemia in diabetes mellitus).
Dietary measures initiated before therapy should be continued.
4.2. Posology and method of administration
In combination with diet, this medicinal product constitutes a long-term
treatment, the efficacy of which should be monitored periodically.
Response to therapy should be monitored by determination of serum lipid
values (total cholesterol, LDLC, triglycerides). If an adequate response has
not been achieved after several months (e.g. 3 months), complementary or
different therapeutic measures should be considered
Adults: The recommended dose is one tablet containing 145 mg
fenofibrate taken once daily. Patients currently taking one 200mg capsule or
one 160 mg tablet can be changed to one 145 mg fenofibrate tablet without
further dose adjustment.
Elderly patients: In elderly patients, the usual adult dose is
Patients with renal impairment: Dosage reduction is required in
patients with renal impairment.
Children: The use of the
145 mg dosage form is contraindicated in children.
Hepatic disease: Patients
with hepatic disease have not been studied.
Method of administration: Tablet
should be swallowed whole with a glass of water.
LIPANTHYL PENTA 145, film-coated tablet may be given at any time of the day,
with or without food
- hepatic insufficiency (including biliary cirrhosis),
- renal insufficiency,
- hypersensitivity to fenofibrate or any component of this medication,
- known photoallergy or phototoxic reaction during treatment with fbrates or
ketoprofen, .,-.gallbladder disease.
Use during pregnancy and lactation:
LIPANTHYL PENTA 145, film-coated tablet should not be taken in patients
allergic to peanut or arachis oil or soybean lecithin or related products
due to the risk of hypersensitivity reactions.
4.4. Special warnings and precautions for use
Secondary cause of hypercholesterolemia, such as uncontrolled type 2
diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia,
obstructive liver disease, pharmacological treatment, alcoholism, should be
adequately treated before fenofibrate therapy is initiated.
For hyperlipidaemic patients taking estrogens or contraceptives containing
oestrogens it should be ascertained whether the hyperlipidaemia is of
primary or secondary nature (possible elevation of lipid values caused by
Liver function: As with other lipid lowering agents, increases have
been reported in transaminase levels in some patients. In the majority of
cases these elevations were transient, minor and asymptomatic. It is
recommended that transaminase levels be monitored every 3 months during the
first 12 months of treatment. Attention should be paid to patients who
develop increase in transaminase levels and therapy should be discontinued
if ASAT and ALAT levels increase to more than 3 times the upper limit of the
normal range or 100 IU.
Pancreatitis: Pancreatitis have been reported in patients taking
fenofibrate. This occurrence may represent a failure of efficacy in patients
with severe hypertriglyceridemia, a direct drug effect, or a secondary
phenomenon mediated through biliary tract stone or sludge formation with
obstruction of the common bile duct.
Muscle: Muscle toxicity, including very rare cases of rhabdomyolysis,
has been reported with administration of fibrates and other lipid-lowering
agents. Patients with hypoalbuminemia and renal insufficiency in their
personal history have a higher incidence of myotoxicity. Muscle toxicity
should be suspected in patients presenting diffuse myalgia, myositis,
muscular cramps and weakness and/or marked increases in CPK (levels
exceeding 5 times the upper normal range). In such cases treatment with
fenofibrate should be stopped.
Patients with pre-disposing factors for myopathy and/or rhabdomyolysis,
including age above 70 years old, personal or familial history of hereditary
muscular disorders, renal impairment, hypoalbuminaemia, hypothyroidism and
high alcohol intake, may be at an increased risk of developing
rhabdomyolysis. For these patients, the putative benefits and risks of
fenofibrate therapy should be carefully weighed up.
The risk of muscle toxicity may
be increased if the drug is administered with another fibrate or an HMGCoA
reductase inhibitor (statins), especially in cases of pre-existing muscular
disease. Consequently, the co-prescription of fenofibrate with a statin
should be reserved to patients with severe combined dyslipidaemia and high
cardiovascular risk without any history of muscular disease. This
combination therapy should be used with caution and patients should be
monitored closely for signs of muscle toxicity.
Renal function: Treatment
should be interrupted in case of an increase in creatinine levels > 50% and
ULN (upper limit of normal). It is recommended that creatinine measurement
may be considered during the first three months after initiation of
This medicinal product contains
lactose, therefore patients with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
should not take this medicine.
This medicinal product contains sucrose, therefore patients with rare
hereditary problems of fructose intolerance, glucose-galactose malabsorption
or sucrase-isomaltase insufficiency should not take this medicine.
LIPANTHYL PENTA 145, film-coated tablet should not betaken inpatients
allergic to soybean lecithin or related products due to the risk of
4.5. Interactions with other
medicinal products and other forms of interaction
Oral anticoagulants: Fenofibrate enhances oral anticoagulant effect
and may increase risk of bleeding. It is recommended that the dose of
anticoagulants is reduced by about one third at the start of treatment and
then gradually adjusted if necessary according to INR (International
Normalised Ratio) monitoring. Therefore, this combination is not
Cyclosporin: Some severe
cases of reversible renal function impairment have been reported during
concomitant administration of fenofibrate and cyclosporin. The renal
function of these patients must therefore be closely monitored and the
treatment with fenofibrate stopped in the case of severe alteration of
HMG-CoA reductase inhibitors
and other fibrates: Concurrent use of lovastatin (or other HMGCoA
reductase inhibitors) may cause severe myositis and myoglobinuria. The risk
of serious muscle toxicity is increased if a fibrate is used concomitantly
with HMG-CoA reductase inhibitors or other fibrates. Such combination
therapy should be used with caution and patients monitored closely for signs
of muscle toxicity.
Cytochrome P450 enzymes: In vitro studies using human liver
microsomes indicate that fenofibrate and fenofibric acid are not inhibitors
of cytochrome (CYP) P450 isoforms CYP3A4, CYP2D6, CYP2E1, or CYP1A2. They
are weak inhibitors of CYP2C19 and CYP2A6, and mild-tomoderate inhibitors of
CYP2C9 at therapeutic concentrations.
4.6 PREGNANCY - BREAST FEEDING
There are no adequate data from the use of fenofibrate in pregnant women.
LIPANTHYL PENTA 145, film-coated tablet should only be used during pregnancy
after a careful benefit/risk assessment.
There are no data on the excretion of fenofibrate and/or its metabolites
into breast milk. LIPANTHYL PENTA 145, film-coated tablet should not be used
4.7. Effects on the ability to
drive and use machines
LIPANTHYL PENTA 145, film-coated tablet has no influence on the ability to
drive and use machines.