Essentiale® forte n

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ESSENZIALE® FORTE N

Composition:

Active ingredient: «Essential phospholipids»Ò = EPLÒ-substance (soybean-derived phospholipids ((3-sn-phosphatidyl)choline) containing all-rac-α-tocopherol);

1 capsule contains «Essential phospholipids»Ò = EPLÒ-substance
(soybean-derived phospholipids ((3-sn-phosphatidyl)choline) containing all-rac-α-tocopherol) – 300 mg;

Excipients: hard fat, refined soybean oil, hydrogenated castor oil, 96% ethanol, ethylvanillin, 4-methoxyacetophenone, capsule shell: gelatin, purified water, titanium dioxide (E 171), yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172), sodium lauryl sulfate.

Pharmaceutical form. Capsules.

Main physicochemical properties: opaque, elongated, hard capsules of khaki color with a pasty content resembling honey.

Pharmacotherapeutic group. Hepatotropic agents. ATC code A05BA.

Pharmacological Properties.

Pharmacodynamics. In liver diseases, hepatocyte membranes and their organelles are always damaged, which may lead to changes in the activity of membrane-bound enzymes and receptor systems, disruption of the cell's metabolic function, and reduced intensity of liver regeneration.

The phospholipids contained in the drug Essentiale® Forte N are chemically similar to endogenous phospholipids but have a much higher content of polyunsaturated (essential) fatty acids. These high-energy molecules are primarily incorporated into cellular membrane structures and facilitate the restoration of damaged liver tissue. Due to the presence of cis-double bonds in these polyene fatty acids, which hinder the parallel alignment of hydrocarbon chains in membrane phospholipids, the packing density of phospholipid structures decreases, thereby increasing the rate of substance influx and efflux. Membrane-bound enzymes form functional units that can enhance their activity and ensure the physiological course of key metabolic processes.

Phospholipids influence impaired lipid metabolism by regulating lipoprotein metabolism, resulting in the conversion of neutral fats and cholesterol into transportable forms, particularly due to increased ability of high-density lipoproteins (HDL) to bind cholesterol, directing them toward further oxidation. During excretion of phospholipids through the biliary tract, the lithogenic index decreases and bile stabilization occurs.

Pharmacokinetics. After oral administration, more than 90% of the drug is absorbed in the small intestine. The majority is cleaved by phospholipase A into 1-acyl-lysophosphatidylcholine, about 50% of which is immediately reacylated into polyunsaturated phosphatidylcholine during absorption in the small intestine. The polyunsaturated phosphatidylcholine enters the bloodstream via lymphatic pathways and is then transported primarily in complex with HDL to the liver. The maximum concentration of phosphatidylcholine in blood 6–24 hours after oral administration averages 20%.

The elimination half-life for the choline component is 66 hours and for saturated fatty acids is 32 hours. In human kinetic studies, less than 5% of each of the administered isotopes 3H and 14C was excreted in feces.

Clinical characteristics.

Indications.

Non-alcoholic steatohepatitis, alcoholic steatohepatitis, acute and chronic hepatitis of various etiologies, liver cirrhosis, pre- and postoperative treatment in surgical interventions on the liver and biliary tract, psoriasis, radiation syndrome.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Data on incompatibility or interaction of Essentiale® Forte N with other medicinal products are not available.

Interaction between Essentiale® Forte N, 300 mg capsules, and anticoagulants cannot be excluded. Therefore, dose adjustment of the medicinal product may be necessary.

Special precautions for use.

In rare cases, this medicinal product may cause severe allergic reactions, as it contains soybean oil.

This medicinal product does not replace the need to discontinue the use of substances that are harmful to the liver (e.g. alcohol).

If you have chronic hepatitis, supportive treatment with soybean phospholipids is advisable only if an improvement in your condition is observed during treatment. If symptoms worsen or if new symptoms of unknown origin occur, the patient should consult a physician.

Use during pregnancy or breastfeeding.

There is limited clinical data available on the use of this medicinal product during pregnancy.

Therefore, the use of Essentiale® Forte N is not recommended during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

When using Essentiale® Forte N, the reaction speed when driving or operating machinery is not affected.

Dosage and Administration.

The initial dose of the drug for adults and children aged 12 years and older is 2 capsules three times daily; the maintenance dose is 1 capsule three times daily. The capsules should be taken during meals, without chewing, and swallowed with a small amount of water. The recommended duration of treatment is at least 3 months.

Treatment of psoriasis begins with taking 2 capsules of Essentiale® Forte N three times daily for 2 weeks. After this period, 10 intravenous injections of 5 ml each are recommended, administered concurrently with PUVA therapy.

After completion of the injection course, oral capsule intake should be resumed and continued for another 2 months.

Children.

The drug is indicated for use in children aged 12 years and older with a body weight of 43 kg or more.

Overdose.

To date, there have been no reports of overdose or intoxication associated with the use of Essentiale® Forte N capsules.

Adverse reactions.

The frequency of adverse effects was determined according to the following criteria: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); frequency not known.

In individual cases, the use of Essentiale® Forte N may cause gastrointestinal disturbances, including stomach discomfort, softening of stools, or diarrhea.

Very rarely, allergic reactions may occur, including exanthema and urticaria. Skin itching is possible (frequency not known). Any adverse effects not listed in this medical instruction should be reported to a physician.

If any of the above-mentioned adverse reactions occur, especially hypersensitivity reactions, administration of Essentiale® Forte N should be discontinued. The patient should consult a physician who will assess the severity of the reaction and prescribe appropriate treatment.

Shelf life. 2 years.

Storage conditions. Keep out of reach of children.

Protect from light and moisture. Store in the original packaging at a temperature not exceeding 25 °C.

Packaging.

Capsules No. 30 (10×3): 10 capsules per blister, 3 blisters per cardboard box.

Capsules No. 90 (10×9): 10 capsules per blister, 9 blisters per cardboard box.

Capsules No. 100 (10×10): 10 capsules per blister, 10 blisters per cardboard box.

Supply category. Over-the-counter (without prescription).

Manufacturer.

A. Nattermann und Cie. GmbH, Germany / A. Nattermann & Cie. GmbH, Germany

(manufacturing, primary and secondary packaging, quality control, and batch release).

Opella Healthcare Poland Sp. z o.o., Poland / Opella Healthcare Poland Sp. z o.o., Poland

(primary and secondary packaging, batch release).

Manufacturer's address and place of business.

Nattermannallee 1, 50829 Cologne, Germany / Nattermannallee 1, 50829 Koeln, Germany

(manufacturing, primary and secondary packaging, quality control, and batch release)

52 Lubelska Str., 35-233 Rzeszow, Poland / 52 Lubelska Str., 35-233 Rzeszow, Poland

(primary and secondary packaging, batch release).

Marketing Authorization Holder.

LLC "Opella Healthcare Ukraine", Ukraine.

Address of the Marketing Authorization Holder.

48-50A Zhilyanska St., Kyiv, 01033, Ukraine.