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Lipanthyl Penta 145

 

1. NAME OF THE MEDICINAL PRODUCT

LIPANTHYL PENTA 145, film-coated tablet


2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 145.0 mg fenofibrate (nanoparticles).

For excipients, see section 6.1.


3. PHARMACEUTICAL FORM

Film-coated tablet.


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 factors.


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


Posology:
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 recommended.
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


4.3. Contraindications
- hepatic insufficiency (including biliary cirrhosis),
- renal insufficiency,
- children,
- 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 oral oestrogen).


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 treatment.

 

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 hypersensitivity reactions

 

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 recommended.

 

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 laboratory parameters.

 

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 during lactation.

 

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.

 

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