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Essentiale Forte N

Name of the medicinal product
Essentiale Forte N capsule

Qualitative and quantitative composition
Drug substance:
One capsule contains:
De-oiled enriched phospholipids from soya-beans 300mg
For the list of excipients see section 6.1.

Pharmaceutical form
Hard capsule for oral use

Clinical particulars
Therapeutic indications
Nutritional support in the management of damaged liver (due to chronic liver disease, liver cirrhosis, fatty liver & intoxication by hepatotoxic substances).

Posology and method of administration
In the beginning take 3 times daily 2 capsules (600 mg phospholipids from soya-beans).
Not more than 6 capsules a day should be taken (1800 mg phospholipids from soya-beans.
After some time the dose may be reduced to 3 times daily 1 capsule (300 mg phospholipids from soya-beans) (maintenance dose).

Contraindications
Known hypersensitivity to soya-bean preparations or to any of the excipients.

Special warnings and precautions for use
Due to the content in soya-bean oil the medicinal product may provoke severe allergic reactions.

The leaflet 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.

Children
As specific studies with Essentiale Forte N have not been conducted, it should not be given to children under 12 years of age.

Interaction with other medicinal products and other forms of Interaction
An interaction of Essentiale Forte N with anticoagulants cannot be excluded. For this reason, dose adjustment of the anticoagulant might be necessary.

The leaflet advises the patient to consult the doctor in the case of simultaneous application.

Pregnancy and lactation
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 N is not recommended during pregnancy and lactation.

Ability to drive and use machines
Essentiale Forte N has no effect on the ability to drive and to use machines.

Undesirable effects
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 N 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 the leaflet.

The leaflet informs that the administration of Essentiale Forte N should be discontinued in the event of one of the above 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.

Overdose
No overdose reaction nor symptom of intoxication has been reported to date with Essentiale Forte N. The leaflet informs that the below 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

Pharmacological properties
Pharmacodynamic properties
ATC Code: A05BA
Among the pharmacodynamic properties were reported hepatoprotective effects found in numerous experimental models into acute liver damage, for example induced by ethanol, alcyl alcohol, carbontetrachloride, 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 properties
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-acyllysophosphatidylcholine, 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 dilinoleoylphosphati-dylcholine (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
halflife 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.

Pharmaceutical particulars
List of excipients
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 laurylsulfate, purified water.

Incompatibilities
Not applicable.

Shelf life
2 Years.

Special precautions for storage
Store in the original container, not above 25C.
Store in the original container in order to protect from humidity.
Do not use after the expiry date.

Nature and contents of container
10, 12, 15, 30, 50, and 60 hard capsules in glass bottles
10, 20, 30, 50, 60, 100 and 500 hard capsules in PVC/ PVDC/ Aluminium blisters.
Not all pack sizes are marketed.

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