Essentiale Forte N

Essentiale Forte N

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Full Prescribing Info
Contents
Phospholipids.
Description
Each capsule contains de-oiled enriched phospholipids from soya beans 300 mg.
Each capsule also contains the following excipients: Ethanol 96%, hard fat, soya bean oil, hydrogenated castor oil, ethyl vanillin, 1-(4-methoxyphenyl) ethanone, α-tocopherol, gelatin, colouring agents: E171, 172, sodium lauryl sulfate, purified water.
Indications/Uses
A herbal preparation that supports the vital functions of the liver.
Dosage/Direction for Use
Adults, Adolescents and Children >12 years (Approximately 43 kg): Initial Dose: 2 hard capsules, 3 times/day (1,800 mg of soya bean phospholipids).
Maintenance Dose: 1 hard capsule, 3 times/day (900 mg of soya bean phospholipids).
If the patient has not taken enough capsules of Essentiale Forte N or if the patient has forgotten a single dose, do not take the double dose next time, but continue as instructed by the physician or in this leaflet. If the patient has any further questions about the use, ask physician or pharmacist.
Administration: Take Essentiale Forte N unchewed with meals and plenty of liquid (preferably with a glass of water).
Basically, the duration of the application is not limited (see Contraindications and Precautions).
Tell physician or pharmacist if the patient has the impression that the effect of Essentiale Forte N is too strong or too weak.
Always take Essentiale Forte N exactly as instructed. If the patient has uncertainty, discuss it with physician or pharmacist.
Overdosage
There is no experience of overdose with Essentiale Forte N.
The adverse reactions may be more pronounced (see Adverse Reactions).
Consult physician in this case, who will decide about any measures that may be necessary.
Contraindications
Hypersensitivity to soya beans preparations or to any of the other ingredients of Essentiale Forte N.
Due to the content in soya bean oil, on rare occasions, Essentiale Forte N may provoke severe allergic reactions.
Special Precautions
If the patient's complaints aggravate or if the patient has other unclear complaints, it is important to tell the physician.
Essentiale Forte N is not a substitute for the avoidance of the noxious agent causing liver damage (eg, alcohol). The use of soya bean phospholipids as an adjuvant therapy is only justified in unhealthy liver conditions when improvement is observed during treatment.
Effects on the Ability to Drive or Operate Machinery: No special precautions.
Use in children: As specific studies with Essentiale Forte N have not been conducted, it should not be given to children <12 years.
Use in pregnancy & lactation: Preparations from soya beans are largely used in human food and so far, no clue has appeared that would suggest any risk during pregnancy and lactation.
Specific results from investigation are not available. For this reason, the use of Essentiale Forte N is not recommended during pregnancy and lactation.
Use In Pregnancy & Lactation
Preparations from soya beans are largely used in human food and so far, no clue has appeared that would suggest any risk during pregnancy and lactation.
Specific results from investigation are not available. For this reason, the use of Essentiale Forte N is not recommended during pregnancy and lactation.
Adverse Reactions
Like all medicines, Essentiale Forte N can have adverse reactions.
For the evaluation of the adverse reactions profile, the following incidences are considered: Very common: Occurring in ≥1 of 10 people who use Essentiale Forte N; common: Occurring in 1-10 of 100 people who use Essentiale Forte N; uncommon: Occurring in 1-10 of 1,000 people who use Essentiale Forte N; rare: Occurring in 1-10 of 10,000 people who use Essentiale Forte N; very rare: Occurring in <1 of 10,000 people who use Essentiale Forte N; not known: Incidence cannot be assessed on grounds of the data available.
Occasionally, gastrointestinal disorders eg, stomach complaints, soft stool and diarrhoea may occur.
On very rare occasions, hypersensitivity reactions may occur eg, cutaneous rash or nettle rash (exanthema, urticaria). Also itching may occur, the incidence not being known.
If the patient notices any of these adverse reactions, especially a hypersensitivity reaction, stop using Essentiale Forte N and tell physician who will decide about the severity and take any necessary measures. If any of the adverse reactions gets serious or if the patient notices any adverse reactions not listed in this leaflet, please tell physician or pharmacist.
Drug Interactions
Inform physician or pharmacist if the patient is taking or have recently taken other medicine, even those not prescribed. An interaction of Essentiale Forte N with anticoagulants cannot be excluded. For this reason, dose adjustment of the anticoagulant might be necessary.
Tell physician if Essentiale Forte N is taken together with anticoagulants.
Storage
Do not store above 30°C.
ATC Classification
A05C - DRUGS FOR BILE THERAPY AND LIPOTROPICS IN COMBINATION ; Used in bile and liver therapy.
Presentation/Packing
Hard capsule 300 mg x 50's.
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