Essentiale Forte N Capsules 300mg N30
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Active ingredients
Phospholipids
Release form
Capsules
Composition
1 capsule contains: Active substance: phospholipids from soybeans containing 76% (3-sn-phosphatidyl) choline (synonyms - essential phospholipids, EPL) 300 mg. Additional substances: solid fat - 57.000 mg, soy bean oil - 36.000 mg, castor oil hydrogenated - 1.600 mg, ethanol 96% - 8.100 mg, ethyl vanillin - 1.500 mg, 4-methoxyacetophenone - 0.800 mg, α-tocopherol - 0.750 mg. Capsule composition: gelatin - 67.945 mg, purified water - 11.495 mg, titanium dioxide (E171) - 0.830 mg, iron dye yellow oxide (E172) - 2.075 mg, iron dye black oxide (E172) - 0.332 mg, iron dye red oxide (E172) - 0.198 mg, sodium lauryl sulfate - 0.125 mg.
Pharmacological effect
Essential phospholipids are the main elements of the structure of the membrane of cells and cell organelles. In liver diseases there is always damage to the membranes of the liver cells and their organelles, which leads to impaired activity of the associated enzymes and receptor systems, deterioration of the functional activity of the liver cells and reduced ability to regenerate. The phospholipids that make up the drug Essentiale; Forte H, correspond in their chemical structure to endogenous phospholipids, but surpass endogenous phospholipids in activity due to the higher content of polyunsaturated (essential) fatty acids in them. Embedding these high-energy molecules in the damaged parts of the cell membranes of hepatocytes restores the integrity of the liver cells and contributes to their regeneration. Cis-double bonds of their polyunsaturated fatty acids prevent the parallel arrangement of hydrocarbon chains in cell membrane phospholipids, the phospholipid structure of cell membranes of hepatocytes is loosened, which causes an increase in their fluidity and elasticity, improves metabolism. The resulting functional blocks increase the activity of enzymes fixed on the membranes and contribute to the normal, physiological pathway of the most important metabolic processes. The phospholipids that make up the drug Essentiale; forte, regulate lipoprotein metabolism, transferring neutral fats and cholesterol to oxidation sites, this is mainly due to the increased ability of high-density lipoproteins to bind to cholesterol. Thus, the drug has a normalizing effect on lipid and protein metabolism, detoxification of the liver, recovery and preservation of the cellular structure of the liver and phospholipid-dependent enzyme systems,which ultimately prevents the formation of connective tissue in the liver and contributes to the natural regeneration of liver cells. When phospholipids are excreted in the bile, the lithogenic index decreases and bile stabilizes.
Pharmacokinetics
Absorption, distribution, metabolism More than 90% of the phospholipids ingested are absorbed in the small intestine. Most of them are cleaved by phospholipase A to 1-acyl-lysophosphatidylcholine, 50% of which is immediately subjected to reverse acetylation in polyunsaturated phosphatidylcholine during the process of absorption in the intestinal mucosa. This polyunsaturated phosphatidylcholine with lymph flow enters the blood and from there, mainly in a high-density form associated with lipoprotenes, enters the liver. Studies of the pharmacokinetics in humans were carried out using radioactively labeled dilinoleyl phosphatidylcholine (3H and 14C). The choline portion was labeled with 3H, and the linoleic acid residue had a 14C.Cmax 3H mark reached 6-24 hours after administration and was 19.9% of the prescribed dose. The T1 / 2 of the choline component was 66 hours. Cmax14C reached 4-12 hours. after administration and amounts to 27.9% of the prescribed dose. T1 / 2 of this component is 32 parts. Both of the isotope are more than 90% absorbed in the intestine. Excretion In feces, 2% of the administered dose of 3H and 4.5% of the administered dose of 14C are detected, in urine 6% of 3H and only a minimal amount of 14C.
Indications
- chronic hepatitis; - cirrhosis; - fatty liver dystrophy of various etiologies; - toxic liver damage; - alcoholic hepatitis; - dysfunction of the liver in other somatic diseases; - pregnancy toxicosis; - prevention of recurrence of gallstone formation; - psoriasis (as a means adjuvant therapy); - radiation syndrome.
Contraindications
- children's age up to 12 years (lack of sufficient evidence); - known hypersensitivity to phosphatidylcholine or other auxiliary ingredients of the drug.
Precautionary measures
Application for violations of liver function Applied according to indications. Use in childrenContraindicated in children under 12 years of age (lack of sufficient evidence base).
Use during pregnancy and lactation
Perhaps the use of the drug during pregnancy according to indications
Dosage and administration
InsideCapsules should be swallowed whole, drinking plenty of water (approximately 1 cup). For adolescents over 12 years old and weighing more than 43 kg, as well as for adults Essentiale; Forte H is recommended to take 2 capsules 3 times / day with meals. As a rule, the duration of use is not limited.
Side effects
Essentiale forte N is usually well tolerated. In order to estimate the frequency of side effects, the following definitions are used: very often (more than 1/10), often (more than 1/100-less than 1/10), infrequently (more than 1/1000-less than 1/100 ), rarely (more than 1/10 000 - less than 1/1000), very rarely (less than 1/10 000), unknown frequency (according to the available data it is impossible to establish the frequency of occurrence). On the part of the digestive system: perhaps - a feeling of discomfort in the stomach, soft stools, diarrhea. Allergic reactions: in very rare cases skin allergic reactions are possible (rash, exant ema, urticaria, itching).
Overdose
Currently, no cases of overdose have been reported.
Interaction with other drugs
Drug interaction of the drug is not described.