LIPANTHYL Penta Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
LIPANTHYL PENTA 145, Film-coated tablet.
2. Qualitative and quantitative composition
One film-coated tablet contains 145.0mg fenofibrate (nanoparticles). <u>Excipients with known effect:</u> each tablet contains: 132.00mg of Lactose monohydrate 145.00mg of Sucrose 0.50 mg of Soybean lecithin ...
3. Pharmaceutical form
Film coated tablet. White, oblong, film-coated tablets engraved 145 on one side and Fournier logo on the other side.
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 ...
4.2. Posology and method of administration
Posology Adults The recommended dose is one tablet containing 145 mg fenofibrate taken once daily. Patients currently taking one 200mg capsule or one 160mg tablet can be changed to one 145 mg fenofibrate ...
4.3. Contraindications
Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality), Known gallbladder disease Severe chronic kidney disease, Chronic or acute pancreatitis with the ...
4.4. Special warnings and precautions for use
<u>Secondary causes of hyperlipidemia:</u> Secondary cause of hypercholesterolemia, such as uncontrolled type 2 diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemia, obstructive liver ...
4.5. Interaction with other medicinal products and other forms of interaction
<u>Oral anticoagulants:</u> 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 ...
4.6. Pregnancy and lactation
Fertility Reversible effects on fertility have been observed in animals (see section 5.3). There are no clinical data on fertility from the use of LIPANTHYL PENTA 145. Pregnancy There are no adequate data ...
4.7. Effects on ability to drive and use machines
LIPANTHYL PENTA 145, film-coated tablet has no influence on the ability to drive and use machines.
4.8. Undesirable effects
The most commonly reported ADRs during LIPANTHYL PENTA 145 therapy are digestive, gastric or intestinal disorders. The following undesirable effects have been observed during placebo-controlled clinical ...
4.9. Overdose
Only anecdotal cases of fenofibrate overdosage have been received. In the majority of cases no overdose symptoms were reported. No specific antidote is known. If an overdose is suspected, treat symptomatically ...
5.1. Pharmacodynamic properties
Serum Lipid Reducing Agents/Cholesterol and Triglycerides Reducers/Fibrates ATC code: C10AB05 Dyslipidaemia Fenofibrate is a fibric acid derivative whose lipid modifying effects reported in humans are ...
5.2. Pharmacokinetic properties
Metabolism and excretion LIPANTHYL PENTA 145, film-coated tablet contains 145 mg of fenofibrate nanoparticles. Absorption Maximum plasma concentrations (C<sub>max</sub>) occur within 2 to 4 hours after ...
5.3. Preclinical safety data
Acute toxicity studies have yielded no relevant information about specific toxicity of fenofibrate. In a three-month oral nonclinical study in the rat species with fenofibric acid, the active metabolite ...
6.1. List of excipients
<u>Core:</u> Sucrose, Lactose monohydrate, Silicified microcrystalline cellulose, Crospovidone, Hypromellose, Sodium lauril sulfate, Docusate sodium, Magnesium stearate. <u>Coating:</u> Polyvinyl alcohol, ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Please refer to the product carton for expiry.
6.4. Special precautions for storage
Store in the original package in order to protect from light and moisture, at a temperature not exceeding 30°C.
6.5. Nature and contents of container
Thermoformed blister strips (clear PVC/PE/PVDC sealed with aluminium complex). Boxes of 30 tablets.
6.6. Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorization holder
Abbott Products Operations AG, Hegenheimermattweg 127, 4123 Allschwil, Switzerland
10. Date of revision of the text
23 Feb 2022
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