Phospholipids [from soya-beans containing 76% of (3-sn-phosphatidyl) choline].
Each capsule contains Phospholipids from soya-beans containing 76% of (3-sn-phosphatidyl) choline (extractant: ethanol 96% v/v) 300 mg.
Excipients/Inactive Ingredients: Hard fat, soya-bean oil, hydrogenated castor oil, ethanol, ethyl vanillin, 4-methoxyacetophenone, gelatin, colourants (E171, E172), DL-alpha-tocopherol.
Liver therapeutic agent. ATC Code: A05BA.
Pharmacology: Pharmacodynamics: Among the pharmacodynamic properties were reported hepatoprotective effects found in numerous experimental models into acute liver damage, for example induced by ethanol, alkyl alcohol, carbon-tetrachloride, paracetamol and galactosamine. Moreover, in chronic models (ethanol, thioacetamide, organic solvents) was seen also the inhibition of steatosis and fibrosis. As active principle has been suggested accelerated membrane regeneration and stabilisation, inhibited lipid peroxidation and inhibited collagen synthesis. Specific investigations into human pharmacodynamics are not available.
Pharmacokinetics: Animal experiments into the pharmacokinetics showed that more than 90% of the orally applied radiolabelled soya-bean phospholipids are absorbed in the small intestine. Most of it is split by phospholipase A to 1-acyl-lyosphosphatidylcholine, 50% of which is reacylated immediately into polyunsaturated phosphatidylcholine still during the process of absorption in the intestinal mucosa. This polyunsaturated phosphatidylcholine reaches the blood via the lymph pathway and from there - mainly bound to HDL - it passes in particular to the liver.
Tests into human pharmacokinetics were performed a.o. with radioactively labeled dilinoleoyl-phosphatidylcholine (3H and 14C). The choline moiety was 3H-labeled and linoleic acid had the 14C-label.
The maximum 3H concentration was achieved after 6 to 24 hours and amounted to 19.9% of the dose. The half-life for the choline component was 66 hours.
The maximum 14C concentration was achieved after 4 to 12 hours and amounted to 27.9% of the dose. The half-life for this component was 32 hours.
In the faeces were found 2% of the 3H and 4.5% of the 14C label, in the urine 6% of the 3H and only minor amounts of the 14C label.
These results show that both isotopes are absorbed to over 90% in the intestine.
Essentiale Forte 300 mg is a preparation for liver disease.
Essentiale Forte 300 mg is applied to improve subjective complaints, such as lack of appetite, sensation of pressure in the right epigastrium due to toxico-nutritional liver damage and in hepatitis.
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Essentiale Forte is taken unchewed with meals with plenty of liquid (e.g. with a glass of water).
Basically, the duration of the application is not limited.
The patient leaflet mentions that the information given under Precautions should be taken into account.
No overdose reaction nor symptom of intoxication has been reported to date with Essentiale Forte 300 mg.
The monograph informs that the listed in Adverse Reactions may be reinforced with greater intensity.
The patient should consult the doctor who may decide about the severity and any measures that might be necessary.
Known hypersensitivity to soya-bean preparations or to any of the excipients. Essentiale Forte 300 mg is contraindicated in patients with a known hypersensitivity to phosphatidylcholine, peanuts, and/or any component of Essentiale Forte 300 mg.
Due to the content in soya-bean oil the medicinal product may provoke severe allergic reactions.
The monograph draws the attention of the patient to the following: This drug therapy is not a substitute for the avoidance of the noxious agent causing liver damage (e.g. alcohol).
In chronic hepatitis the adjuvant therapy with soya-bean phospholipids is justified only when improved subjective well-being becomes manifest during therapy.
The doctor should be consulted when complaints aggravate or when other unclear complaints occur.
Ability to drive and use machines: Essentiale Forte 300 mg has no effect on the ability to drive and to use machines.
Use in Children: As specific studies with Essentiale Forte 300 mg have not been conducted, it should not be given to children under 12 years of age.
Preparations from soya-beans are largely used in human food and so far no events have been reported that would suggest any risk during pregnancy. Specific results from investigation are not available. For this reason, the use of Essentiale Forte 300 mg is not recommended during pregnancy and lactation.
For the evaluation of any adverse effects the following incidences are considered: very frequent (≥ 1/10), frequent (≥ 1/100 to < 1/10), occasional (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to <1/1,000), very rare (< 1/10,000).
Occasionally the administration of Essentiale Forte 300 mg may provoke gastrointestinal disorders, such as stomach complaints, soft stool and diarrhoea.
On very rare occasions allergic reactions may occur, such as exanthema or rash and urticaria. Pruritus (frequency unknown). The doctor or pharmacist should be informed about any undesirable effect not listed in the monograph.
Administration of Essentiale Forte 300 mg should be discontinued in the event of one of the previously mentioned side effects, especially in hypersensitivity reactions. The patient should consult the doctor who may decide about the severity and any measures that might be necessary.
An interaction of Essentiale Forte 300 mg with anticoagulants cannot be excluded. For this reason, dose adjustment of the anticoagulant might be necessary.
The monograph advises the patient to consult the doctor in the case of simultaneous application.
Store in the original container, not above 30°C.
Store in the original container in order to protect from humidity.
Shelf-life: 2 years.
A05BA10 - phospholipids ; Belongs to the class of drugs used in liver therapy.
Essentiale Forte hard cap 300 mg
50's;90's
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