1 capsule contains: De-oiled, enriched phospholipids from soya-beans 300 mg.
Excipients/Inactive Ingredients: Ethanol 96%, hard fat, soya-bean oil (Ph. Eur.), hydrogenated castor oil, ethyl vanillin, 1-(4-methoxyphenyl)ethanone, alpha tocopherol, gelatin, colouring agents E 171, 172, sodium lauryl sulfate, purified water.
ATC Code: A05BA.
Pharmacology: Pharmacodynamics: Among the pharmacodynamic properties reported were hepatoprotective effects found in numerous experimental models into acute liver damage (induced by ethanol, alcyl alcohol, carbon tetrachloride, paracetamol and galactosamine). Furthermore, it was also seen to inhibit steatosis and fibrosis in chronic liver damage models (induced by ethanol, thioacetamide, organic solvents). Its suggested principal actions have been through accelerated membrane regeneration and stabilization, inhibited lipid peroxidation and inhibited collagen synthesis.
Pharmacokinetics: Animal experiments into the pharmacokinetics showed that more than 90% of the orally applied soya-bean phospholipids are absorbed in the small intestine. Most of it is split by phospholipase A to 1-acyl-lysophosphatidylcholine, 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 with radioactively labeled dilinoleoyl-phosphatidylcholine (3H and 14C). The choline moiety was 3H-labeled and the 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 amount of the 14C label.
These results show that both isotopes are absorbed to over 90% in the intestine.
Nutritional support in the management of damaged liver (due to chronic liver disease, liver cirrhosis, fatty liver & intoxication by hepatotoxic substances).
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Phospholipids (Essentiale Forte P) 300 mg hard gel capsule 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 monograph 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 Phospholipids (Essentiale Forte P) 300 mg hard gel capsule.
The monograph informs that the listed undesirable effects may be reinforced.
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.
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.
Consult the doctor when complaints aggravate or when other unclear complaints occur.
Effects on ability to drive and use machines: Phospholipids (Essentiale Forte P) 300 mg hard gel capsule has no effect on the ability to drive and to use machines.
Use in Children: As information about the administration in children is insufficient, Phospholipids (Essentiale Forte P) 300 mg hard gel capsule should not be given to children under 12 years of age.
Due to the content in soya-bean oil the medicinal product may provoke severe allergic reactions.
Preparations from soya-beans are largely used in human food and so far no clue has appeared that would suggest any risk during pregnancy. Results from investigation are insufficient. For this reason, the use of Phospholipids (Essentiale Forte P) 300 mg hard gel capsule 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 Phospholipids (Essentiale Forte P) 300 mg hard gel capsule may provoke gastrointestinal disorders, such as stomach complaints, soft stool and diarrhoea.
On very rare occasions allergic reactions may occur, such as exanthema and urticaria. The doctor or pharmacist should be informed about any undesirable effect not listed in this monograph.
The monograph informs that the administration of Phospholipids (Essentiale Forte P) 300 mg hard gel capsule should be discontinued in the event of one of the previously mentioned side undesirable 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 Phospholipids (Essentiale Forte P) 300 mg hard gel capsule with anticoagulants cannot be excluded. For this reason, dose adjustment of the anticoagulant might be necessary.
Consult a doctor in the case of simultaneous application.
Incompatibilities: Not applicable.
Store in the original container, not above 25°C.
Store in the original container in order to protect from humidity.
Shelf life: 2 Years.
A05C - DRUGS FOR BILE THERAPY AND LIPOTROPICS IN COMBINATION ; Used in bile and liver therapy.
Hard cap 300 mg (hard gelatin) x 50's.