Эссенциале® forte N

General characteristics. Structure:

Active ingredient: the phospholipids from soybeans containing 76% (E-vp-fosfatidil) - sincaline (synonyms: EPL, essential phospholipids) -  mg E00;
auxiliary ingredients: fat firm - 57,000 mg, soybeans oil - 36,000 mg, the castor oil hydrogenated - 1,600 mg, ethanol of 96% - 8,100 mg, ethylvanillin - 1,500 mg, 4-metoksiatsetofenon - 0,800 mg, and - tocopherol - 0,750 mg.
Structure of the capsule: gelatin - 67,945 mg, the water purified - 11,495 mg, titanium dioxide (Е 171)-0,830 mg, dye ferrous oxide yellow (Е 172) - 2,075 mg, dye ferrous oxide black (Е 172) - 0,332 mg, dye ferrous oxide red (Е 172) - 0,198 mg, sodium lauryl sulfate
- 0,125 mg.
Description. The solid gelatin opaque capsules No. 1 of brown color containing the oily pasty mass of yellowish-brown color.

Pharmacological properties:

Pharmacodynamics. Essential phospholipids are basic elements of structure of a cover of cells and cellular organellas. At liver diseases there is always a damage of covers of hepatic cells and their organellas which leads to disturbances of activity of the related enzymes and systems of receptors, deterioration in functional activity of hepatic cells and decline in the ability to regeneration.
The phospholipids which are a part of the drug Essentsiale® forte of N correspond on the chemical structure to endogenous phospholipids, but surpass endogenous phospholipids in activity at the expense of higher content in them polyunsaturated (essential) fatty acids. Embedding of these highly power molecules to the damaged sites of cellular membranes of hepatocytes recovers integrity of hepatic cells, promotes their regeneration. Cis-double bonds of their polyunsaturated fatty acids prevent a parallel arrangement of hydrocarbon chains in phospholipids of cellular covers, the phospholipidic structure of cellular covers of hepatocytes "is loosened" that causes increase in their flowability and elasticity, improves a metabolism. The formed functional blocks increase activity of the enzymes fixed on membranes and promote a normal, physiological way of course of the major metabolic processes.
The phospholipids which are a part of the drug Essentsiale® forte regulate metabolism of lipoproteins, transferring neutral fats and cholesterol to places of oxidation, mainly it occurs due to increase in ability of lipoproteins of high density to contact cholesterol.
Thus, the normalizing effect is had on metabolism of lipids and proteins; on disintoxication function of a liver; on recovery and preservation of cellular structure of a liver and fosfolipidozavisimy fermental systems; what finally interferes with formation of connecting fabric in a liver and promotes natural recovery of cells of a liver.
At excretion of phospholipids in bile there is a decrease in a litogenny index and stabilization of bile.

Pharmacokinetics. More than 90% of the phospholipids accepted inside are soaked up in a small intestine. Their most part is split by a phospholipase And to 1-acyl-lizofosfatidilkholina which 50% immediately are exposed to the return acetylation in polyunsaturated phosphatidylsincaline even during process of absorption in a mucous membrane of intestines. This polyunsaturated phosphatidylsincaline with current of a lymph gets to blood and from there, mainly, in the look connected with lipoproteins of high density comes to a liver.
Pharmacokinetics researches at people were conducted with the help dilinoleit phosphatidylsincaline with a radioactive label (3H and 14C). A choline part was marked 3H, and the rest of linolic acid had as a tag  of C.
The maximum concentration of H is reached in 6-24 hours after introduction and makes 19,9% of the appointed dose. The elimination half-life of a choline component makes 66 hours.
The maximum concentration 14C is reached in 4-12 hours after introduction and makes up to 27,9% of the appointed dose. The elimination half-life of this component makes 32 hours. In Calais 2% of the entered dose 3H and 4,5% of the entered dose 14C, in urine - 6% from 3H and only the minimum quantity 14C are found.
Both isotopes more than for 90% are soaked up in intestines.

Indications to use:

- Chronic hepatitises, cirrhosis, fatty dystrophy of a liver of various etiology, toxic damages of a liver, alcoholic hepatitis, abnormal liver functions at other somatopathies.
- Pregnancy toxicosis.
- Prevention of a recurrence of formation of gallstones.
- Psoriasis (as means of auxiliary therapy).
- Radiation syndrome.

Route of administration and doses:

Inside. Capsules should be swallowed entirely, washing down with enough water (about 1 glass).
For teenagers 12 years and weighing more than 43 kg are more senior, and also for adult Essentsiale® forte the N is recommended to accept on 2 capsules - 3 times a day during food.
As a rule, duration of use is not limited.

Side effects:

Эссенциале® forte the N is usually well had by patients.
For assessment of frequency of side effects the following definitions are used: very often (> 1/10), it is frequent (> 1/100 - <1/10), is not frequent (> 1/1000 - <1/100), is rare (> 1/10000 - <1/1000), is very rare (<1/10000), the unknown frequency (according to the available data it is not possible to establish emergence frequency).
From digestive tract
In certain cases reception of Essentsiale® forte of N can cause gastric discomfort, a soft chair or diarrhea.
Allergic reactions
Skin allergic reactions (rash, dieback, urticaria, itch) are seldom or never possible.

Contraindications:

The known hypersensitivity to phosphatidylsincaline or other auxiliary ingredients of drug.
Children's age up to 12 years (lack of sufficient evidential base).

Storage conditions:

Period of validity 3 years. Not to use drug after the period of validity specified on packaging.
To store at a temperature not above 21 °C. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

Capsules of 300 mg.
1) On 10 capsules in the blister from PVC and aluminum foil. On 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 blisters together with the application instruction in a cardboard pack.
2) On 10 capsules in the blister from PVC and aluminum foil. On 5 blisters in a cardboard pack. On 3 cardboard packs together with the application instruction in a cardboard box.
3) On 12 capsules in the blister from PVC and aluminum foil. On 3, 4, 5, 6, 7, 8, 9, 10 or 11 blisters together with the application instruction in a cardboard pack.
4) On 15 capsules in the blister from PVC and aluminum foil. On 2, 3, 4, 5, 6, 7, 8 or 10 blisters together with the application instruction in a cardboard pack.