Essentiale forte H capsules №10х9

Name Essentiale forte N caps. The main active ingredient containing 76%, Phospholipids from soybeans Release formCapsules Dosage300mg Special instructionsIn rare cases, this drug can cause severe allergic reactions, as it contains soybean oil. The use of the drug in children under the age of 12 years is not recommended due to the lack of a sufficient number of studies. Taking this drug is not a substitute for avoiding the damaging effects of certain substances on the liver (such as alcohol). Maintenance treatment with “essential” phospholipids is justified only if there is an improvement in the patient’s symptoms during treatment. If symptoms worsen or other unclear symptoms appear, the patient should consult a doctor. Pharmacodynamics Hepatoprotective effects have been reported in numerous experimental models of acute liver injury (such as those caused by ethanol, carbon tetrachloride, paracetamol and galactosamine). Inhibition of fibrosis and steatosis has also been noted in studies in chronic models. Accelerated recovery and stabilization of membranes, inhibition of lipid peroxidation and collagen synthesis were noted. No specific pharmacodynamic studies have been conducted in humans. Damage to the membranes of liver cells and their organelles can occur in all liver diseases, which can lead to disruption of the activity of membrane-bound enzymes and receptor systems, disruption of the metabolic function of cells, and reduced liver regeneration. The chemical structure of the phospholipids that make up Essentiale® forte N corresponds to that of endogenous phospholipids, but they are superior to the latter due to their high content of polyunsaturated (essential) fatty acids. The inclusion of these high-energy molecules mainly in the membrane fractions of hepatic cells promotes the regeneration of damaged liver tissue. Since the cis-double bonds of their polyenoic acids prevent the parallel arrangement of the hydrocarbon chains of the phospholipid membranes, the density of the phospholipid structures is weakened, which increases the metabolic rate. Functional units with membrane-bound enzymes are formed, which can enhance their activity and ensure the flow of basic metabolic processes in a physiological way. Phospholipids interfere with impaired lipid metabolism by regulating lipoprotein metabolism so that neutral fats and cholesterol are converted into transportable forms, mainly by increasing HDL cholesterol-binding capacity, and thus can be subject to oxidation. In the process of excretion of phospholipids through the biliary system, the lithogenic index decreases and bile stabilizes. Pharmacokinetics Animal pharmacokinetic studies using radiolabeled phospholipids showed that more than 90% of them were absorbed in the small intestine. Most of the ingested phospholipids are cleaved by phospholipase A to 1-acyl-lysophosphatidylcholine, 50% of which is reacylated during absorption in the intestinal mucosa directly into polyunsaturated phosphatidylcholine. This polyunsaturated phosphatidylcholine enters the bloodstream via the lymphatic pathways and from there – mainly in a bound state with HDL – it enters, in particular, into the liver. Pharmacokinetic studies in humans have been performed using radioactively labeled dilinoleylphosphatidylcholine (3H and 14C). The choline moiety was labeled with 3H and the linolenic acid residue was labeled with 14C. The maximum concentration of 3H in the blood was reached 6-24 hours after administration and amounted to 19.9% of the dose taken. The half-life of the choline component was 66 hours. The maximum concentration of 14C was reached 4-12 hours after ingestion and amounted to 27.9% of the dose taken. The half-life of this component was 32 hours. With faeces, 2% 3H and 4.5% 14C of the taken dose were excreted, with urine – 6% 3H and only a minimal amount of 14C. Both isotopes were more than 90% bound in the gut. Preclinical Safety Data No repeated dose toxicity studies have been conducted with soybean phospholipids. Toxicological studies of phosphatidylcholine (a component of phospholipids from soybeans) were conducted in dogs (for 6 weeks) and in rats (for 48 weeks) by oral administration. NOAEL (Maximum Inactive Substance Concentration) in dog studies was 1000 mg/kg bw, in rat studies it was 3750 mg/kg bw, both approximately 20 times the equivalent human dose. In studies in rats, oral doses of bean phospholipids up to a concentration of 3750 mg/kg body weight (approximately 17 times the human equivalent dose) had no effect on fertility. In studies in rats and rabbits, oral doses of phospholipids up to concentrations of 1000 mg/kg body weight and 500 mg/kg body weight, respectively (approximately 4.5 times the human equivalent dose) did not cause teratogenic effects. However, since the studies carried out are not complete and do not meet modern requirements, a final assessment of the results associated with embryotoxicity cannot be made. In an animal experiment, phosphatidylcholine (an ingredient of phospholipids from soybeans) at therapeutic doses did not show teratogenic and embryotoxic effects. The lowest teratogenic-embryotoxic effect was detected after oral administration of a daily dose of more than 1,000 mg/kg body weight in rats and more than 500 mg/kg body weight in rabbits (which is approximately 5.6 times the equivalent dose for humans). No mutagenic properties of phospholipids have been identified in previous in vitro studies. Carcinogenicity has not been evaluated. Indications for use Essentiale forte N is a herbal preparation used to treat liver diseases. Essentiale forte N is used in patients with chronic hepatitis or various alimentary-toxic liver damage caused by substances harmful to the liver and / or malnutrition, to reduce symptoms such as loss of appetite and / or a feeling of heaviness in the right hypochondrium. Method of administration and doses The standard dosing regimen for children from 12 years of age and adults: a single dose is 2 capsules, the total daily dose is 2 capsules 3 times a day. There are no time restrictions on the use of the drug. The recommended duration of treatment is 3 months. The attending physician may recommend a different dosage and duration of treatment, depending on the patient’s condition and the course of the disease. Take the capsules during a meal, without chewing, with a small amount of water. Use in Pregnancy and Lactation The widespread use of soybeans as food has not revealed any risks during pregnancy and during breastfeeding. Due to the lack of sufficient studies, it is not recommended to use this drug without medical supervision during pregnancy. Due to the lack of data on the penetration of phospholipids from soybeans and their metabolites into breast milk, it is not recommended to use the drug during breastfeeding. Fertility In the course of preclinical animal studies, the effect of the drug on male or female fertility has not been identified. Interaction with other drugs An interaction of Essentiale® forteN with anticoagulants cannot be ruled out. You may need to adjust the dose of the anticoagulant. Contraindications Essentiale forte N is contraindicated in patients with known hypersensitivity to phosphatidylcholine, soybeans, peanuts and / or to any component of the drug. Composition One capsule of Essentiale® forte N contains: Active ingredient: “Essential” phospholipids – the substance EPL® (diglyceride esters of cholinephosphoric acid of natural origin, soybean extract, with a high content of unsaturated fatty acids, mainly linoleic acid (about 70%), linolenic and oleic acids) 300 mg. Excipients: solid fat, refined soybean oil, α-tocopherol, hydrogenated castor oil, ethanol 96%, ethylvanillin, 4-methoxyacetophenone, gelatin, purified water, titanium dioxide E 171, yellow iron oxide E172, black iron oxide E172, iron oxide red E172, sodium lauryl sulfate. Overdose So far, there have been no reports of overdose-related reactions or symptoms of intoxication when using the drug Essentiale® forte N. The use of a dose exceeding the recommended one may lead to side effects with greater intensity. Side effect Characteristics of the frequencies of adverse reactions by systemic organ classes: very often (? 1/10), often (? 1/100, but < 1/10), infrequently (? 1/1000, but < 1/100), rarely ( ? 1/10000, but < 1/1000), very rarely (< 1/10000), the frequency is unknown (the frequency cannot be estimated based on the available data). Immune system disorders: Frequency unknown: allergic reactions, including severe anaphylactic reactions and Quincke's edema. Skin and subcutaneous tissue disorders: Frequency unknown: exanthema, rash, urticaria, pruritus. Gastrointestinal disorders: Frequency unknown: indigestion, soft stools, diarrhea. Reporting adverse reactions It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance of the medicinal product. Storage conditionsKeep in a dry place out of the reach of children. Store at a temperature not exceeding 21 ° C. 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