Essentiale Forte N caps 300mg #180

Essentiale Forte N instruction for use

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Essentiale forte N is a drug with a hepatoprotective effect.

Release form and composition

Dosage form of Essentiale forte N - capsules: hard gelatinous, opaque, brown, size No. 1; the capsules contain a yellowish-brown paste-like oily mass (in blisters made of a combination of aluminum foil with PVC, PVC / PTFE or PVC / PE / PVDC; in a cardboard box 1-15 or 18 blisters of 10 pcs.; in a cardboard box 6 cardboard boxes with containing 3 blisters of 10 pcs .; in a cardboard box 3 cardboard packs with 5 or 6 blisters of 10 pcs .; in a cardboard box 3-11 or 15 blisters of 12 pcs .; in a cardboard box 2-8, 10 or 12 blisters 15 pcs.).
Composition of 1 capsule:
    active substance: phospholipids from soybeans with a content of 76% choline (3-sn-phosphatidyl) (synonyms - EPL, Essentiale phospholipids) - 300 mg;
    auxiliary components: α-tocopherol - 0.75 mg; solid fat - 57 mg; hydrogenated castor oil - 1.6 mg; soybean oil - 36 mg; 96% ethanol - 8.1 mg; 4-methoxyacetophenone - 0.8 mg; ethyl vanillin - 1.5 mg;
    capsule: gelatin - 67.945 mg; sodium lauryl sulfate - 0.125 mg; titanium dioxide (E171) - 0.83 mg; dye iron oxide black (E172) - 0.332 mg; dye iron oxide yellow (E172) - 2.075 mg; dye iron oxide red (E172) - 0.198 mg; purified water - 11.495 mg.

Pharmacodynamics

Essentiale phospholipids are the main element of the structure of the membrane of cells and cell organelles. Against the background of liver diseases, damage to the membranes of hepatic cells and their organelles is always noted, which is the cause of disturbances in the activity of enzymes and receptor systems associated with them, deterioration of the functional activity of liver cells and a decrease in the ability to regenerate.
The phospholipids included in Essentiale forte N correspond in their chemical structure to endogenous phospholipids, but due to the higher content of Essentiale (polyunsaturated) fatty acids in them, they surpass them in activity. After the incorporation of these high-energy molecules into the damaged areas of the cell membranes of hepatocytes, the integrity of the liver cells is restored, which contributes to their regeneration. Due to the cis-double bonds of their polyunsaturated fatty acids, the parallel arrangement of hydrocarbon chains in the phospholipids of the cell walls is prevented. The phospholipid structure of the cell membranes of hepatocytes is thus "loosened". This leads to an increase in their elasticity and fluidity and leads to an improvement in metabolism. The formed functional blocks increase the activity of enzymes fixed on the membranes, which in turn helps to improve the physiological pathway of important metabolic processes.
Essentiale phospholipids transport cholesterol and neutral fats to oxidation sites and regulate lipoprotein metabolism, which is mainly due to an increase in the ability of high density lipoproteins to bind to cholesterol.
Essentiale forte N, therefore, has a normalizing effect on the metabolism of proteins and lipids, detoxification function of the liver, preservation and restoration of the cellular structure of the liver and phospholipid-dependent enzyme systems. This ultimately promotes the natural regeneration of liver cells and prevents the formation of connective tissue in it.
When phospholipids are excreted into bile, stabilization of bile and a decrease in the lithogenic index are observed.

Pharmacokinetics

More than 90% of Essentiale phospholipids taken orally are absorbed in the small intestine. Most of them undergo cleavage by phospholipase A to 1-acyl-lysophosphatidylcholine, 50% of which, even during the absorption process in the intestinal mucosa, immediately undergoes reverse acetylation into polyunsaturated phosphatidylcholine. With the flow of lymph, this polyunsaturated phosphatidylcholine enters the bloodstream and from there enters the liver, mainly in the form associated with high density lipoproteins.
Pharmacokinetic studies in humans were carried out using radiolabeled dilinoleoylphosphatidylcholine (3H - choline part, 14C - linoleic acid residue).
The time to reach Cmax (maximum concentration of the substance) 3H and 14C is 6-24 / 4-12 hours after administration (is 19.9% ​​/ 27.9% of the prescribed dose, respectively).
T1 / 2 (half-life) 3H - 66 hours, 14C - 32 hours.
Both isotopes are absorbed in the intestine by more than 90%.
3H in feces / urine is found in the amount of 2% / 6% of the administered dose, 14C - 4.5% / minimum amount.

Indications for use

    cirrhosis of the liver;
    toxicosis of pregnancy;
    chronic hepatitis;
    fatty degeneration of the liver of various origins;
    alcoholic hepatitis;
    toxic liver damage;
    impaired liver function with other somatic diseases;
    gallstone disease (in order to prevent recurrence of the formation of gallstones);
    radiation syndrome;
    psoriasis (as an adjuvant therapy).

Contraindications

    age up to 12 years;
    established individual intolerance to any of the components of the drug.

Instructions for use

Essentiale forte N is taken orally, preferably with meals. The capsules must be swallowed whole with sufficient water (about 1 cup).
The recommended dosing regimen for adults and children over 12 years of age weighing more than 43 kg: 3 times a day, 2 capsules.
The duration of use is not limited.

Side effects

The drug is generally well tolerated by patients.
Possible side reactions:
    digestive system: diarrhea, soft stools, stomach discomfort;
    allergic reactions: in very rare cases (<0.01%) - itching, exanthema, rash, urticaria.

Pediatric use

According to the instructions, Essentiale forte N is not prescribed to patients under 12 years of age, which is due to the lack of necessary data confirming the safety / effectiveness of therapy.

Drug interactions

Information on the interaction of Essentiale forte N with other drugs / substances is not provided.

Terms and conditions of storage

Store in a place protected from children at temperatures up to 21 ° C.
Shelf life:
    capsules packed in a blister made of aluminum foil and PVC - 3 years;
    capsules packed in a blister made of aluminum foil and PVC / PTFE or PVC / PE / PVDC - 2.5 years.

Reviews

According to reviews, Essentiale forte N is an effective drug used in the treatment of liver diseases. Of the advantages, it is noted that it can be used by pregnant women with toxicosis. Of the shortcomings, they point to the high cost and the need for a long course.

Terms of sell

You don't need a prescription to buy Essentiale Forte N.