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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 25°C.
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. |
