Essentiale forte N - instructions for use, dose, side effects, contraindications

Excipients: solid fat - 57 mg; soy bean oil - 36 mg; castor oil, hydrogenated - 1.6 mg; ethanol (96%) 8.1 mg; ethylvaniline - 1.5 mg; 4-methoxyacetophenone 0.8 mg; α-tocopherol - 0.75 mg;

capsule: gelatin - 67,945 mg; purified water - 11.495 mg; titanium dioxide (E171) - 0.83 mg; ferric iron oxide yellow (E172) 2.075 mg; ferric oxide black oxide (E172) - 0.332 mg; iron dye red oxide (E172) - 0.198 mg; sodium lauryl sulfate - 0.125 mg.

Description:Hard gelatinous opaque capsules No. 1 of brown color, containing an oily paste-like mass of a yellowish brown color.

Pharmacotherapeutic group:hepatoprotective agent

ATX: & nbsp

A.05.C Combination of drugs for the treatment of diseases of the liver and biliary tract

Pharmacodynamics:Essential phospholipids are the main elements in the structure of the cell membrane and cellular organelles of the liver. In diseases of the liver, there is always damage to the membranes of the liver cells and their organelles, which leads to disturbances in the activity of the enzymes and receptor systems associated with them, impairment of the functional activity of the hepatic cells, and a decrease in the ability to regenerate.
Phospholipids, which are part of the preparation Essentiale® forte H, correspond in their chemical structure to endogenous phospholipids, but exceed the endogenous phospholipids by activity due to the higher content of polyunsaturated (essential) fatty acids in them. The incorporation of these high-energy molecules into the damaged parts of the cell membranes of hepatocytes restores the integrity of the hepatic cells, promotes their regeneration.Cis-double bonds of their polyunsaturated fatty acids prevent the parallel arrangement of hydrocarbon chains in the phospholipids of cell membranes, the phospholipid structure of the cellular membranes of hepatocytes "loosens", 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 promote the normal, physiological pathway of the most important metabolic processes.
The phospholipids that make up Essentiale Forte N regulate lipoprotein metabolism by transferring neutral fats and cholesterol to oxidation sites, mainly by increasing the ability of high-density lipoproteins to bind to cholesterol.
Thus, there is a normalizing effect on the metabolism of lipids and proteins; on the detoxification function of the liver; on the restoration 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 recovery of cells.
In the excretion of phospholipids in bile there is a decrease in the lithogenic index and stabilization of bile.

Pharmacokinetics:More than 90% of the ingested phospholipids are absorbed in the small intestine. Most of them are cleaved by phospholipase A to 1-acyl-lysophosphatidylcholine, 50% of which immediately undergoes reverse acetylation to polyunsaturated phosphatidylcholine during the absorption process in the intestinal mucosa. This polyunsaturated phosphatidylcholine with shock lymph enters the bloodstream and from there, mainly associated with high density lipoproteins to the liver form.
Studies of pharmacokinetics in humans were carried out using dilanololephosphatidylcholine with a radioactive label (3H and 14C). The choline part was labeled with 3H, and the remainder of linolenic acid had a 14C label.
The maximum concentration of 3H is reached 6-24 hours after administration and is 19.9% of the prescribed dose. The half-life of the choline component is 66 hours.
The maximum concentration of 14C is reached 4-12 hours after administration and is 27.9% of the prescribed dose. The half-life of this component is 32 hours.In the feces, 2% of the administered dose of 3H and 4.5% of the administered 14C dose are detected, in urine 6% of 3H and only a minimum of 14C.
Both isotopes are more than 90% bound in the intestine.

Indications:Chronic hepatitis, liver cirrhosis, fatty degeneration of the liver of various etiologies, toxic liver damage, alcoholic hepatitis, impaired liver function in other somatic diseases, toxicosis of pregnancy,
prevention of recurrence of gallstones, psoriasis (as a means of supporting therapy), radiation syndrome.

Contraindications:Known hypersensitivity to phosphatidylcholine or other auxiliary ingredients of the drug, children under 12 years of age (lack of sufficient evidence base).

Dosing and Administration:

Inside. Capsules should be swallowed whole, with enough water (about 1 cup).

For adolescents over 12 years of age and body weight over 43 kg, as well as for adults Essentiale^® Fort H is recommended to take 2 capsules 3 times a day during meals.

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

Side effects:

Essentiale^® fort H 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); infrequently (≥ 1/1000, <1/100); rarely (≥ 1/10 000, <1/1000); very rarely (<1/10 000); unknown frequency (it is impossible to determine the frequency of occurrence from the available data).

From the side GIT: in some cases, the reception Essentiale^® Forte H can cause gastric discomfort, mild stools, or diarrhea.

Allergic reactions: in very rare cases - skin allergic reactions (rash, exanthema, hives, itching) are possible.

Interaction:Till now unknown.

Form release / dosage:

Capsules, 300 mg.

Packaging:

10 capsules in a blister of PVC and aluminum foil. 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15 blisters are placed in a cardboard box.

2) 10 capsules in a blister of PVC and aluminum foil. For 5 blisters are placed in a cardboard box. For 3 cardboard packs are placed in a cardboard box.

3) 12 capsules per blister of PVC and aluminum foil. By 3, 4, 5, 6, 7, 8, 9, 10 or 11 blisters are placed in a cardboard box.

4) 15 capsules in a blister of PVC and aluminum foil. By 2, 3, 4, 5, 6, 7, 8 or 10 blisters are placed in a cardboard box.

Storage conditions:At a temperature not exceeding +21 °C, out of the reach of children.

Shelf life:3 years. Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N011496 / 01

Date of registration:31.03.2006

The owner of the registration certificate:A. Nattermann and Sie. GmbHA. Nattermann and Sie. GmbH Germany

Manufacturer: & nbsp

A.NATTERMANN and Cie., GmbH Germany

Representation: & nbspSanofi Russia, JSCSanofi Russia, JSCRussia

Information update date: & nbsp20.10.2015

Illustrated instructions

Instructions

Essentiale® Fort H (Essentiale® forte N)