ESSENTIALE FORTE

Package leaflet: Information for the patient

Essentiale Forte, 300 mg, capsules
Phospholipidum essentiale
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Table of contents

1. What Essentiale Forte is and what it is used for
2. Important information before taking Essentiale Forte
3. How to take Essentiale Forte
4. Possible side effects
5. How to store Essentiale Forte
6. Contents of the pack and other information

1. What Essentiale Forte is and what it is used for

Essentiale Forte is a herbal medicinal product used in liver disorders.
It contains essential phospholipids (Phospholipidum essentiale), which are glycerol esters of
phosphatidylcholine and unsaturated fatty acids: linoleic, linolenic, and oleic acid.
Due to the presence of polyunsaturated fatty acids in their side chains, these phospholipids cannot
be synthesized in the body.
The phospholipids contained in Essentiale Forte are incorporated into the membranes of liver cells
after reaching the liver. This replenishes existing deficiencies caused by the disease process and
promotes faster regeneration of damaged liver cells.
Phospholipids are essential for the differentiation and proliferation of liver cells.
They inhibit liver fibrosis by reducing collagen production and increasing the activity of collagenase,
the enzyme responsible for collagen breakdown.
Incorporation of phospholipids into liver cell membranes reduces the sensitivity of these cells to
damaging factors of the immune system.
Phospholipids are excreted into bile, where they reduce the cholesterol/phospholipid ratio and
increase cholesterol solubility—thanks to the emulsifying properties of essential phospholipids,
this plays an important role in the prevention of gallstone formation.
Alongside bile acids, phospholipids play a key role in fat digestion and in the absorption of fat-soluble
vitamins.
Moreover, the polyunsaturated fatty acids contained in phospholipids reduce cholesterol levels and
normalize serum lipoprotein levels—exerting beneficial anti-atherosclerotic effects. They also enhance
cholesterol transport from extrahepatic tissues to the liver and activate lipolytic enzymes.
Polyunsaturated fatty acids improve blood flow through blood vessels by reducing platelet adhesion and
increasing red blood cell flexibility.

Indications
Reduces subjective patient complaints such as: loss of appetite, feeling of pressure in the right upper
abdomen caused by liver damage due to improper diet, exposure to toxic substances, or during
hepatitis.

2. Important information before using Essentiale Forte

When not to use Essentiale Forte

• if the patient is allergic to the active substance, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Essentiale Forte, discuss it with your doctor or pharmacist.

• The use of Essentiale Forte cannot replace the elimination from the diet of harmful substances causing liver damage (e.g. alcohol).
• In chronic hepatitis, supportive treatment with Essentiale Forte is justified only if, during therapy, the patient experiences an improvement in general well-being.

If there is no improvement within 7 days, if symptoms worsen, new symptoms appear, or
other non-specific symptoms occur, consult a doctor.
Children and adolescents
There is insufficient data on the use of Essentiale Forte in children under 12 years of age. Therefore,
Essentiale Forte should not be used in children under 12 years of age.
Essentiale Forte with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Consult your doctor before using this medicine together with anticoagulant agents.
Essentiale Forte with food and drink
Take the capsules during meals, without chewing (swallow with, for example, a glass of water).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Soybeans are a common food component, and so far no harmful effects on pregnancy have been observed with their consumption. However, sufficient studies have not been conducted. Therefore, the use of this medicine during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
Essentiale Forte has no influence on the ability to drive or operate machinery.
Essentiale Forte contains soybean oil, ethanol, and sodium
Due to the presence of soybean oil, this medicine may cause severe allergic reactions.
Do not use if hypersensitivity to peanuts or soy has been diagnosed.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. the medicine is considered "sodium-free".
This medicine contains 10 mg of alcohol (ethanol) per capsule, which corresponds to
20.49 mg/g (2.05% w/w).
The amount of ethanol in one capsule is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to use Essentiale Forte

This medicine should always be used exactly as described in the patient leaflet or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Adults and children over 12 years: 2 capsules three times daily.
The capsules should be taken during meals, without chewing (swallowed with, for example, a glass of water).
Generally, there are no time limitations regarding the duration of treatment with Essentiale Forte; however, the recommended duration of treatment should be at least 1–3 months.
The length of treatment may also be individually determined by the doctor.
Use in children and adolescents
There is insufficient data on the use of Essentiale Forte in children under 12 years of age. Therefore, Essentiale Forte should not be used in children under 12 years of age.
Accidental overdose of Essentiale Forte
Cases of overdose with Essentiale Forte have not been reported to date.
If a dose higher than recommended is taken, the undesirable effects described below may become more pronounced.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Unknown frequency (frequency cannot be estimated from the available data):
an allergic reaction may occur, such as erythema, rash, urticaria, itching, gastrointestinal disturbances
e.g. nausea, vomiting, loose stools, diarrhoea, abdominal discomfort, increased blood pressure,
palpitations, dizziness.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in the leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Essentiale Forte

Keep this medicine out of sight and reach of children.
Store below 25 °C and protect from moisture.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Essentiale Forte contains

• The active substance is: phospholipids from soybean seeds containing (3-sn-phosphatidyl)choline; 1 capsule contains 300 mg.
• The other ingredients are: refined soybean oil, hydrogenated castor oil, hydrogenated vegetable glycerides (Witepsol W 35), higher fatty acid triglycerides (Witepsol S 55), ethanol, ethylaniline, p-methoxyacetophenone, α-tocopherol.

Capsule shell: gelatin, yellow iron oxide (E 172), black iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate, purified water.

What Essentiale Forte looks like and contents of the pack
Yellow to brownish, honey-like viscous paste in a green, opaque, elongated capsule.
Pack contains 50, 90, 100 or 180 capsules.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
{Sanofi logo}

Manufacturer
A.Nattermann & Cie. GmbH
Nattermannallee 1
D-50829 Cologne, Germany

Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
ul. Lubelska 52
35-233 Rzeszów

For further information, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
tel.: +48 22 280 00 00