Ozone Esslial forte capsules 300mg # 30

Dosage form

Hard gelatin capsules No. 0.

The body and cap of the capsule are dark brown, opaque.

The content of the capsules is a yellowish brown or brown homogeneous mass from an oily to a denser consistency with a characteristic odor.

Structure

1 capsule contains:

Active substance: lipoid PPL-400 - 400.0 mg, in terms of polyunsaturated phospholipids from soy lecithin (PPL fraction) -300.0 mg, with an average content of La-phosphatidylcholine 76% 228.0 mg.

Excipients: ethyl alcohol 95% - 4.0 mg.

Hard gelatin capsules No. 0:

The composition of the capsule body: iron dye black oxide - 0.53%, iron dye red oxide - 0.93%, iron dye yellow oxide - 0.2%, titanium dioxide -0.3333%, gelatin - up to 100%

The composition of the capsule cap: iron dye black oxide - 0.53%, iron dye red oxide -0.93%, iron dye yellow oxide - 0.2%, titanium dioxide -0.3333%, gelatin - up to 100%

Pharmacodynamics

Essential phospholipids are the main structural elements of the cell membrane and cell organelles of the liver.

In liver diseases, there is always damage to the membranes of the liver cells and their organelles, which leads to disruptions in the activity of enzymes and receptor systems associated with them, impairment of the functional activity of liver cells and a decrease in the ability to regenerate.

The phospholipids that make up the Esslial Forte preparation 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. The incorporation of these high-energy molecules into the damaged areas of the cell membranes of hepatocytes restores the integrity of the hepatic cells and promotes their regeneration. The cis-double bonds of their polyunsaturated fatty acids prevent the parallel arrangement of hydrocarbon chains in the phospholipids of cell membranes, the density of the phospholipid structure of the cell walls of hepatocytes decreases, which leads to an increase in their fluidity and elasticity, and 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 Esslial Forte, regulate lipoprotein metabolism, 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 and phospholipid-dependent enzyme systems

which ultimately prevents the formation of connective tissue in the liver and promotes natural regeneration of liver cells.

When phospholipids are excreted into bile, the lithogenic index decreases and bile stabilizes.

Pharmacokinetics

More than 90% of the phospholipids taken orally 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 enters the bloodstream with the lymph flow, and from there, mainly in the form associated with high density lipoproteins, enters the liver.

Pharmacokinetic studies in humans were carried out using radioactively labeled dilinoleyl phosphatidylcholine (3H and 14C).

The choline part was labeled with 3H, and the lipolic acid residue was labeled with 14C.

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 up to 27.9% of the prescribed dose.

The half-life of this component is 32 hours.

Both isotopes are more than 90% absorbed in the intestine

Side effects

Esslial Forte is usually well tolerated by patients.

In order to estimate the frequency of side effects, the following definitions are used: very often (> 1/10), often (> 1/100 - < 1/10), ns often (> 1/1000 - < 1/100), rarely (> 1 / 10000 - < 1/1000), very rare (< 1/10000), unknown frequency (the frequency of occurrence cannot be determined from the available data).

From the gastrointestinal tract: rarely - discomfort in the epigastric region, loosening of the stool, nausea, gastralgia.

Allergic reactions: very rarely - rash, exanthema, urticaria

unknown frequency - itching.

Special conditions

Influence on the ability to drive vehicles and mechanisms: no data

Indications

Chronic hepatitis, liver cirrhosis, fatty degeneration of the liver of various etiologies, toxic liver damage, alcoholic hepatitis, liver dysfunctions in other somatic diseases.

Toxicosis of pregnancy, prevention of recurrence of the formation of gallstones, psoriasis (as an adjuvant therapy), radiation syndrome.

Contraindications

Individual intolerance to phosphatidylcholine or other auxiliary components of the drug.

Soy intolerance.

Children under 12 years of age (lack of sufficient evidence).

Drug interactions

no information

Dosage

Inside.

The capsules should be taken whole with a sufficient amount of water (approximately 1 glass).

For adolescents over 12 years of age and weighing more than 43 kg, as well as for adults, Esslial Forte is recommended to take 2 capsules - 3 times a day with meals.

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

Overdose

no information

Storage conditions

The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25 В° C.

Shelf life 3 years.

Name ENG

ESSLIVER FORTE

Clinical and pharmacological group

Hepatoprotector

ATX code

Combination of drugs for the treatment of liver and biliary tract diseases

Dosage

300mg

Structure

1 capsule contains: Active substance: lipoid PPL-400 - 400.0 mg, in terms of polyunsaturated phospholipids from soy lecithin (PPL fraction) -300.0 mg, with an average content of La-phosphatidylcholine 76% 228.0 mg.

Excipients: ethyl alcohol 95% - 4.0 mg.

Hard gelatin capsules No. 0: The composition of the capsule body: iron dye black oxide - 0.53%, iron dye red oxide - 0.93%, iron dye yellow oxide - 0.2%, titanium dioxide -0.3333%, gelatin - up to 100%

The composition of the capsule cap: iron dye black oxide - 0.53%, iron dye red oxide -0.93%, iron dye yellow oxide - 0.2%, titanium dioxide -0.3333%, gelatin - up to 100%

Indications

Chronic hepatitis, liver cirrhosis, fatty degeneration of the liver of various etiologies, toxic liver damage, alcoholic hepatitis, liver dysfunctions in other somatic diseases.

Toxicosis of pregnancy, prevention of recurrence of the formation of gallstones, psoriasis (as an adjuvant therapy), radiation syndrome.

INN / Active ingredient

Multivitamins + Phospholipids

Storage conditions and periods

In a dark place at a temperature not exceeding 25 degrees.

Expiration date: 3 years

Contraindications

Hypersensitivity to the components of the drug, children under 12 years of age.

Use with caution during pregnancy, lactation.

Specifications

Category

Preparations for the gastrointestinal tract

,

Hepatoprotectors

Scope of the drug

Gastrointestinal tract

Release form

Capsules

Manufacturer country

Russia

Package quantity, pcs

thirty

Minimum age from

12 years

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Brand name

Ozone OOO

The amount of the dosage form in the primary package

10 pieces.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Hepatoprotective agent

Dosage form

Capsules

The target audience

Adult

Expiration date in days

1095

Package weight, g

45

Mode of application

:

Inside.

< br> Capsules should be taken whole with a sufficient amount of water (about 1 glass).

< br> For adolescents over 12 years old and weighing more than 43 kg, as well as for adults, Esslial Forte is recommended to take 2 capsules - 3 times a day with meals.

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

Anatomical and therapeutic characteristics

:

A05C Drugs for the treatment of liver and biliary tract diseases in combination

Dosage (volume) of the substance in the preparation

:

phospholipids (essential phospholipids) (containing phosphatidylcholine 29%, phosphatidylethanolamine, etc.) 300 mg, thiamine mononitrate 6 mg, riboflavin 6 mg, pyridoxine hydrochloride 6 mg, alpha-tocopherol acetate (in the form of a semi-finished product 50%: alpha-tocopherol acetate

Information on technical characteristics, delivery set, country of manufacture