Instructions for Essentiale Forte N capsules No. 100
Composition
active ingredient: “Essential Phospholipids”Ò= EPLÒ-substance (phospholipids from soybeans ((3-sn-phosphatidyl)choline), which contain all-rac-a-tocopherol);
1 capsule contains “Essential Phospholipids”Ò= EPLÒ-substance
(phospholipids from soybeans ((3-sn-phosphatidyl)choline), which contain all-rac-a-tocopherol) – 300 mg;
excipients: solid fat, refined soybean oil, hydrogenated castor oil, ethanol 96%, ethyl vanillin, 4-methoxyacetophenone, empty capsule: 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.
Dosage form
Capsules.
Main physicochemical properties: opaque, oblong, hard khaki capsules with pasty contents resembling honey.
Pharmacotherapeutic group
Hepatotropic drugs. ATX code A05B A.
Pharmacological properties
Pharmacodynamics. In liver diseases, hepatocyte membranes and their organelles are always damaged, which can lead to changes in the activity of membrane-bound enzymes and receptor systems, disruption of the metabolic function of the cell, and a decrease in the intensity of liver regeneration.
Phospholipids contained in the preparation EssentialeÒ forte H are similar in chemical structure to endogenous phospholipids, but have a much higher content of polyunsaturated (essential) fatty acids. These high-energy molecules are mainly incorporated into the structures of cell membranes and facilitate the restoration of damaged liver tissues. Since the cis-double bonds of these polyenoic acids prevent the parallel arrangement of the hydrocarbon chains of membrane phospholipids, the density of the arrangement of phospholipid structures decreases, as a result of which the rate of entry and excretion of substances increases. Membrane-bound enzymes form functional units that can enhance their activity and ensure the physiological course of basic metabolic processes.
Phospholipids affect impaired lipid metabolism by regulating lipoprotein metabolism, as a result of which neutral fats and cholesterol are converted into forms suitable for transport, especially by increasing the ability of high-density lipoproteins (HDL) to bind cholesterol, and are directed for further oxidation. During the excretion of phospholipids through the biliary tract, the lithogenic index decreases and bile is stabilized.
Pharmacokinetics. When taken orally, more than 90% of the drug is absorbed in the small intestine. The main amount is broken down by phospholipase-A to 1-acyl-lyso-phosphatidylcholine, 50% of which is immediately reacylated into polyunsaturated phosphatidylcholine during absorption in the small intestine. Polyunsaturated phosphatidylcholine enters the blood through the lymphatic system and is then transported to the liver, mainly in a complex with HDL. The maximum content of phosphatidylcholine in the blood 6–24 hours after oral administration is on average 20%.
The half-life for the choline component is 66 hours, for the saturated fatty acids – 32 hours. In human kinetic studies, less than 5% of each of the administered 3H and 14C isotopes was excreted in the feces.
Indication
Non-alcoholic steatohepatitis, alcoholic steatohepatitis, acute and chronic hepatitis of various etiologies, liver cirrhosis, pre- and postoperative treatment for surgical intervention on the liver and biliary tract, psoriasis, radiation syndrome.
Contraindication
Hypersensitivity to any of the components of the drug.
Interaction with other medicinal products and other types of interactions
There is no data on the incompatibility or interaction of Essentiale® forte H with other drugs.
An interaction between Essentiale® forte H, 300 mg capsules, and anticoagulants cannot be ruled out. Therefore, it may be necessary to adjust the dose of this medicinal product.
Application features
In rare cases, this medicine may cause severe allergic reactions because it contains soybean oil.
This medicine does not replace the cessation of substances that damage the liver (such as alcohol).
If you have chronic hepatitis, maintenance treatment with soybean phospholipids is only advisable if your condition improves with treatment. If symptoms worsen or if other unexplained symptoms appear, the patient should consult a doctor.
Use during pregnancy or breastfeeding
There is a limited amount of clinical trial data on the use of the drug in pregnant women.
Therefore, the use of Essentiale® forte H is not recommended during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using Essentiale Forte H, the reaction speed when driving or working with other mechanisms does not change.
Method of administration and doses
The initial dose of the drug for adults and children over 12 years of age is 2 capsules 3 times a day, maintenance - 1 capsule 3 times a day. Capsules are taken during meals, not chewed, washed down with a small amount of water. The recommended course of treatment is at least 3 months.
Psoriasis treatment begins with taking 2 capsules of Essentiale Forte H 3 times a day for 2 weeks. After that, 10 intravenous injections of 5 ml are recommended with simultaneous administration of PUVA therapy.
After the end of the course of injections, resume taking the capsules and continue using the drug for 2 months.
Children.
The drug is intended for use in children aged 12 years and older, whose body weight is 43 kg or more.
Overdose
To date, there have been no reports of overdose or intoxication when using Essentiale® forte N capsules.
Adverse reactions
The frequency of side effects was determined using the following criteria: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); frequency unknown.
In some cases, taking Essentiale® forte H may cause gastrointestinal disturbances, including stomach discomfort, loose stools, or diarrhea.
Very rarely, allergic reactions may occur, including exanthema and urticaria. Itching of the skin is possible (frequency unknown). If you notice any undesirable effects not listed in the instructions for medical use, you should inform your doctor.
If any of the above-mentioned side effects occur, especially hypersensitivity reactions, Essentiale® forte N should be discontinued. The patient should consult a doctor who will be able to determine the severity of the reaction and prescribe the necessary treatment.
Expiration date
3 years.
Storage conditions
Keep out of reach of children.
Store in a dry place at a temperature not exceeding 21 °C.
Packaging
Capsules No. 30 (10×3): 10 capsules in a blister, 3 blisters in a cardboard box.
Capsules No. 100 (10×10): 10 capsules in a blister, 10 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
A. Nattermann & Cie. GmbH, Germany
(production, primary and secondary packaging, control and batch release).
Sanofi-Aventis Sp. z oo, Poland/ Sanofi-Aventis Sp. z oo, Poland
(primary and secondary packaging, batch production).
Location of the manufacturer and address of its place of business.
Nattermannallee 1, Koeln, Nordrhein-Westfalen, 50829, Germany
(production, primary and secondary packaging, control and batch release)
52 Lubelska Str., 35-233 Rzeszow, Poland/52 Lubelska Str., 35-233 Rzeszow, Poland
(primary and secondary packaging, batch production).
Applicant.
Opela Healthcare Ukraine LLC, Ukraine.
Location of the applicant.
Ukraine, 01033, Kyiv, Zhylyanska St., 48-50A.
