ESSENTIALE FORTE N CAPSULES 300MG

Tradename:

Essentiale® forte N

Dosage Form:

capsules

Composition

1 capsule contains:

• active ingredient: phospholipids from soybeans containing 76% (3-sn-phosphatidyl) - choline (synonyms: EPL, essential phospholipids) - 300 mg;
• auxiliary ingredients: solid fat - 57,000 mg, soy bean oil - 36,000 mg, hydrogenated castor oil - 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 (E 171) - 0.830 mg, iron dye yellow oxide (E 172) - 2.075 mg, iron dye black oxide (E 172) - 0.332 mg, iron dye red oxide ( E 172) - 0.198 mg, sodium lauryl sulfate - 0.125 mg.

Description

Solid gelatin opaque capsules No. 1 are brown in color, containing an oily, paste-like mass of yellowish-brown.

Pharmacotherapeutic group: hepatoprotective agent

Pharmacological properties

Pharmacodynamics

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 a decrease in the ability to regenerate.

Phospholipids, which are part of Essentiale® Forte N preparation, correspond in their chemical structure to endogenous phospholipids, but surpass endogenous phospholipids in activity due to their higher content of polyunsaturated (essential) fatty acids. Embedding these highly energetic 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 increases 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.

Phospholipids, which are part of Essentiale® Forte, regulate lipoprotein metabolism, transferring neutral fats and cholesterol to oxidation sites, mainly due to the increased ability of high-density lipoproteins to bind to cholesterol.

Thus, it turns out to be a normalizing effect on the metabolism of lipids and proteins; on the detoxification function of the liver; to restore andpreservation 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.

With the excretion of phospholipids in the bile, the lithogenic index decreases and bile stabilizes.

Pharmacokinetics

More than 90% of ingested phospholipids 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 into polyunsaturated phosphatidylcholine during the process of absorption in the intestinal mucosa. This polyunsaturated phosphatidylcholine with a current of lymph enters the blood and from there, mainly in the form of high density associated with lipoproteins, enters the liver.

Human pharmacokinetics studies were performed using radioactively labeled dilinoleyl phosphatidylcholine (3H and 14C). The choline portion was labeled with 3H, and the linoleic acid residue had 14C as the label.

The maximum concentration of 3H is reached after 6-24 hours after administration and amounts to 19.9% ​​of the prescribed dose. The half-life of the choline component is 66 hours.

The maximum concentration of 14C is reached in 4-12 hours after administration and amounts to 27.9% of the prescribed dose. The half-life of this component is 32 hours. 2% of the administered dose of 3H and 4.5% of the administered dose of 14C are detected in feces, 6% of the 3H in the urine and only a minimal amount of 14C.

Both isotopes are more than 90% absorbed in the intestine.

Indications for use

• Chronic hepatitis, cirrhosis of the liver, fatty degeneration of the liver of various etiologies, toxic liver damage, alcoholic hepatitis, abnormal liver function in other somatic diseases.
• Toxicosis of pregnancy.
• Prevention of recurrence of gallstones.
• Psoriasis (as a means of adjuvant therapy).
• Radiation syndrome.

Contraindications

Known hypersensitivity to phosphatidylcholine or other auxiliary ingredients of the drug.

Children's age up to 12 years (lack of sufficient evidence).

Dosage and administration

Inside Capsules should be swallowed whole, drinking plenty of water (about 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 a day with meals.

As a rule, the duration of application is not limited.

Side effect

Essentiale® forte N is usually well tolerated by patients.

In order to assess the frequency of side effects, the following definitions are used: very often (> 1/10), often (> 1/100 - <1/10), not often (> 1/1000 - <1/100), rarely (> 1 / 10000 - <1/1000), very rarely (<1/10000), unknown frequency (according to the available data it is not possible to establish the frequency of occurrence).

From the gastrointestinal tract

In some cases, Essentiale® Forte H may cause gastric discomfort, soft stools or diarrhea.

Allergic reactions

In very rare cases, allergic skin reactions (rash, rash, urticaria, pruritus) are possible.

Release form

Capsules 300 mg.

3 years.

Do not use the drug after the expiration date printed on the package.

Storage conditions

Store at a temperature not higher than 21 ° C.

Keep out of the reach of children.